דרושים Regulatory Affairs Associate Iii ב-טבע ב-בריטניה

We are seeking an experiencedAssociate Director, Medical Complianceto provide strategic leadership within our UK & Ireland Medical Affairs organisation. You will bring your extensive medical compliance experience and expertise to this senior-level position, operating autonomously while delivering medical compliance excellence across all Teva activities in the UK and Ireland.

As a Subject Matter Expert (SME), you will drive medical compliance excellence, support key strategic initiatives, and make a meaningful impact on patient outcomes through compliant project implementation.

Success in this role will be by measured by following metrics:

• Ensure full compliance with Teva SOPs, ABPI Code of Practice and IPHA code
• Zero PMCPA/HPRA complaints or successful defence of any complaints received
• Effective risk stratification of complex projects to ensure efficient implementation while maintaining compliance
• Achievement of business objectives through strategic thinking, proactively facilitating stakeholder dialogue and compliant operational processes
• Zero or minor observations in internal audits
• Stakeholder confidence metrics measured through internal surveys showing compliance function is seen as enabling (not blocking) business objectives

• Final Signatory Activities
  • Serve as final signatory for medical compliance approvals
  • Review and approve materials, processes, and initiatives to ensure regulatory compliance
• Medical Compliance Leadership
  • Actas primary PMCPA/MHRA and IPHA/ HPRA contact for medical compliance matters
  • Develop and deliver ongoing training programs for final signatories (medical and commercial), AQPs, and reviewers
  • Serve as main medical compliance liaison for TPE/Global teams
  • Active participation as Compliance Committee member
  • Facilitate Code training workshops across the organisation
  • Liaise with Senior Manager, Meical Compliance and Therapy Area Leads to ensure PSP governance

• People Management
  • Oversee activities and performance of Manager and Senior Manager, Medical Compliance
  • Ensure Manager, Medical Compliance effectively maintains SOPs, compliance documentation (Glorya and Studium), and supports medical operations systems
  • Drive efficient project implementation through proper system utilisation and approvals processes
  • Ensure Senior Manager, Medical Compliance approves materials in a timely manner and provides governance to various projects.

• Audit and Inspection Leadership
  • Lead and/ or support audits and inspections across multiple areas: Pharmacovigilance, Congresses, promotional materials, PSP, Veeva, and PMCPA/ IPHA
  • Ensure audit readiness and compliance across all audited functions
  • Strategic Support and Process Optimisation
  • Provide SME support for process optimisation and continuous improvement initiatives
  • Ensure Medical Affairs and Brand Plans comply with Teva SOPs, ABPI Code and IPHA code
  • Ensure Medical Affairs KPls are aligned with regulatory requirements and company standards
  • Support Medical Affairs Capability Mapping and Development programs
  • Liaise with Compliance Officer on key projects

• System Administration
  • Managing key platforms: Glorya (document management), Studium (training management), EngageMate (HCP engagement) and Veeva Promomats (promotional and non-promotional materials approval)
  • Configure EngageMate and Veeva Promomats systems for compliant and efficient project implementation

• Strategic Project Support
  • Partner with Senior Medical and Technical Director on high-priority initiatives
  • Collaborate with project coordinators to implement key strategic projects
  • Provide compliance expertise for ad hoc business requirements

Do you have...?

• Extensive experience as a final signatory with demonstrated independent decision-making authority
• Experience successfully leading and transforming a medical compliance function (not just participating)
• Proven track record of establishing compliance frameworks from scratch or significantly improving underperforming functions
• Demonstrated ability to challenge and influence key stakeholders on compliance matters without compromising standards
• Proven track record of SME input for process improvement
• Experience of managing and configuring platforms such as Veeva Promomats (promotional and non-promotional materials approval)
• Experience managing direct relationships with MHRA/PMCPA and HPRA/IPHA as the primary organisational representative
• Experience of PMCPA case defences where candidate was the lead strategist (not just a contributor)
• Demonstrated experience preventing PMCPA complaints through proactive stakeholder education and process improvements
• Evidence of preventing regulatory issues through proactive risk identification and stakeholder education
• Track record of participating in industry level initiatives to shape compliance frameworks
• Demonstrated experience making unpopular compliance decisions that were later validated
• Demonstrated experience of balancing compliance considerations and business goals using risk stratification strategies
• Proven ability to recover from compliance failures and implement sustainable improvements
• Evidence of successfully managing compliance during organisational change

Are you...?

• A qualified Physician or a Pharmacist with experience in the Pharmaceutical Industry. Desirable: Master's degree in business administration (MBA), Operations Management, or Process Improvement. Having a process improvement certification (Lean Six Sigma Green Belt/Black Belt, Lean Management, Change Management) will also be desirable.
• The final decision-maker (not advisor) on compliance matters
• Able to building or rebuilding stakeholder confidence after compliance failures
• Able to demonstrate openness to feedback and continuous learning mindset
• Willing to adapt approaches based on evidence and stakeholder feedback
• Able to exhibit collaborative leadership style with ability to influence
• Able to think outside the box while maintaining regulatory compliance
• Proactive
• Good communicator

Whether you're growing your family or pursuing new adventures, ourenhanced maternity and paternity leave, sabbaticals, and hybrid working policiesare here to support you through life’s most meaningful moments. Financial wellbeing matters too, which is why we offer anenhanced pension scheme, access to a discount store, and free financial coaching through Bippit.

To help you grow with confidence, we offer a structuredtraining and development programmetailored to your role and department, equipping you with the tools, knowledge, and support you need to thrive.

Senior Medical and Technical Director

The internal career site is available from your home network as well. If you have trouble accessing your EC account, please contact your local HR/IT partner.

We are seeking an experienced

Success in this role will be measured by:

• Team performance and development outcomes

• KOL engagement quality and satisfaction scores

• Strategic initiative completion and impact

• Territory coverage and engagement metrics

• Scientific collaboration outputs

• Compliance and regulatory adherence

• Cross-functional partnership effectiveness

• Team Leadership & Management

  • Lead, manage, and develop a team of MSLs across UK and Ireland

  • Provide coaching, mentoring, and performance management to ensure team excellence

  • Conduct regular field visits and joint HCP interactions to support MSL development

  • Oversee recruitment, onboarding, and training of MSL team members

  • Foster a collaborative and high-performance team culture

  • Develop ongoing MSL training plan

• Key Opinion Leader (KOL) Relationship Management

  • Establish and maintain strategic relationships with nationally important KOLs

  • Lead engagement with key medical centres and academic institutions at the highest level

  • Support and enhance MSL interactions with regional and local KOLs

  • Develop and execute national KOL engagement strategies

  • Represent the company at major scientific meetings and congresses

• Strategic Planning & Execution

  • Collaborate with therapeutic area and field sales teams to develop comprehensive field medical strategies

  • Translate corporate medical strategies into actionable field execution plans

  • Ensure alignment between field medical objectives and business priorities

  • Monitor and evaluate strategy effectiveness, adapting approaches as needed

  • Provide strategic insights and market intelligence to therapeutic area teams

• Scientific Excellence

  • Maintain deep therapeutic area expertise and stay current with medical literature

  • Provide scientific leadership and credibility in interactions with healthcare professionals

  • Support medical information requests and scientific discussions

  • Contribute to medical publications, research collaborations, and scientific initiatives

  • Ensure compliance with all medical and regulatory requirements

• Cross-functional Collaboration

  • Partner with medical affairs, commercial, regulatory, and clinical teams

  • Support product launch preparations and lifecycle management activities

  • Contribute to medical education programs and advisory board planning

  • Collaborate with global and EU medical teams on key initiatives

  • Liaise with MSL managers from other countries to share best practices

• Strategic Partnership & Representation

  • Deputise for Senior Medical and Technical Director as appropriate

  • Partner with Senior Medical and Technical Director on high-priority strategic initiatives

  • Collaborate with project coordinator on key strategic project implementation

  • Represent Medical Affairs at UK, Ireland, EU, and global meetings

Do you have...?

• Advanced degree in life sciences (MD, PHD, Pharmacy, or equivalent) is a must. Desirable: post-graduate qualification in neurology, psychiatry, gastroenterology or immunology

• Extensive pharmaceutical industry experience in medical affairs or MSL roles, including experience of managing MSLs

• Proven leadership experience managing high-performing teams

• Previous experience managing geographically dispersed teams preferred

• Experience of launching new products, especially in neurology, psychiatry or gastroenterology

• Experience of engaging with key stakeholders in neurology, psychiatry or Gastroenterology

• Knowledge of treatment landscapes in neurology, psychiatry or Gastroenterology

• Strong understanding of pharmaceutical regulations and compliance requirements

• Experience with clinical trial management, especially Phase II/ III/ IV

• Knowledge of UK and Irish regulatory landscapes

• Experience of pre-launch medical planning for a new product launch

• Experience in supporting formulary inclusion of new products

• Experience in working with Market Access Teams

• Experience of working in the NHS

• Proficiency in CRM systems and medical affairs databases

• Experience with scientific literature databases and analysis tools

• Advanced presentation and facilitation skills

• Project management capabilities

Are you...?

• An strategic thinker
• Proactive
• Good communicator
• Happy with the below travel requirements:

  • Extensive travel required (60-70%) across UK and Ireland

  • This role requires 'time on territory' of 3 to 4 days per week.

  • International travel for meetings and conferences

  • Overnight stays required for field visits, MSL coaching and meetings

Whether you're growing your family or pursuing new adventures, ourenhanced maternity and paternity leave, sabbaticals, and hybrid working policiesare here to support you through life’s most meaningful moments. Financial wellbeing matters too, which is why we offer anenhanced pension scheme, access to a discount store, and free financial coaching through Bippit.

To help you grow with confidence, we offer a structuredtraining and development programmetailored to your role and department, equipping you with the tools, knowledge, and support you need to thrive.

Senior Medical and Technical Director

The internal career site is available from your home network as well. If you have trouble accessing your EC account, please contact your local HR/IT partner.

Success in this role will be measured by:

• Strategic impact on product portfolio growth
• Team performance and development outcomes
• Regulatory compliance maintenance
• Clinical trial strategy implementation success
• Stakeholder satisfaction and engagement levels
• Contribution to Teva's Pivot to Growth objectives

• Strategic Medical Support
  • Mature Brands
  • Complex Gx & Biosimilars
  • OTC products
  • Pipeline products
• Promotional and non-promotional material review and approval
  • Serve as final medical signatory for promotional and non-promotional materials
  • Ensure compliance with ABPI Code of Practice, IPHA Code, and relevant regulations including
  • Provide regulatory compliance guidance to Medical and Marketing departments.
  • Support Senior Manager, Operations Excellence in improving process of Promotional and non-promotional material review and approval
  • Support Manager, Medical Compliance to enhance Veeva Promomats system on an ongoing basis to improve efficiency.
• Governance & Compliance
  • Ensure Governance and compliance with Teva Internal SOPs and ABPI/ IPHA Code and training for the wider medical team
  • Ensure governance and support for congress planning
  • Ensure medical inquiries are managed according to internal SOPs and regulatory requirements
  • Maintain high standards for medical information accuracy and timeliness
• Team Leadership & Development
  • Lead and inspire a high-performing scientific services team in a dynamic environment
  • Take full accountability for team performance, development, and career progression
  • Manage medical project budgets effectively
  • Support capability mapping and development aligned with Pivot to Growth strategy
  • Develop and track medical affairs capability plans

• Clinical Trial Strategy and Execution
  • Liaise with Senior Manager, Medical Compliance to build clinical trial phases II-IV capabilities within the medical team through comprehensive training programs
  • Enhance UK/Ireland credibility for efficient regulatory approvals, site initiation, and patient recruitment
• Strategic Partnership & Representation
  • Deputise for Senior Medical and Technical Director UK & Ireland as appropriate
  • Partner with Senior Medical and Technical Director on high-priority strategic initiatives
  • Collaborate with project coordinators on key strategic project implementation
  • Represent Medical Affairs at UK, Ireland, EU, and global meetings
  • Drive cross-functional decision-making and stakeholder engagement

Do you have...?

• Extensive pharmaceutical industry experience with significant medical affairs exposure
• Experience of launching products in Gastroenterology
• Experience of engaging with stakeholders in Gastroenterology
• Knowledge of treatment landscape in Gastroenterology, preferably in Inflammatory Bowel Disease (IBD)
• Proven leadership experience managing high-performing teams
• Strong understanding of pharmaceutical regulations and compliance requirements
• Experience with clinical trial management, especially Phase II/ III
• Demonstrated strategic thinking and business acumen
• Knowledge of UK and Irish regulatory landscapes
• Experience as a final signatory
• Experience in engaging with NICE and SMC
• Experience in working with Market Access and HEOR Teams

Are you...?

• A qualified Physician or a Pharmacist with experience in the Pharmaceutical Industry. Desirable: Post-graduate qualification in gastroenterology or immunology
• Open to feedback and continuous learning
• Willing to adapt approaches based on evidence and stakeholder feedback
• Able to exhibit collaborative leadership style with ability to influence
• Able to think outside the box while maintaining regulatory compliance
• Proactive
• Good communicator
• Open for occasional travel for meetings, congresses, and site visits as required
• Flexible to work across different time zones for global collaboration

Whether you're growing your family or pursuing new adventures, ourenhanced maternity and paternity leave, sabbaticals, and hybrid working policiesare here to support you through life’s most meaningful moments. Financial wellbeing matters too, which is why we offer anenhanced pension scheme, access to a discount store, and free financial coaching through Bippit.

To help you grow with confidence, we offer a structuredtraining and development programmetailored to your role and department, equipping you with the tools, knowledge, and support you need to thrive.

Senior Medical and Technical Director

The internal career site is available from your home network as well. If you have trouble accessing your EC account, please contact your local HR/IT partner.

As a part of Global procurement team, your responsibilities will include:

• Own new reporting solution by providing a single point of contact for all procurement related topics, provide training, proper documentation and align business requirements with IT
• Implement new reporting solutions and tools within Global Procurement to support Business needs
• Other projects/duties to be assigned as needed/appropriate. Examples may include process creation/enhancement, cross-functional team participation, etc.
• Regular (e.g. monthly) and ad-hoc data gathering, reporting, consolidation and analysis of the data to ensure high data quality
• Point of contact for external functions: such as Finance, Legal, Supply Chain etc. who requires data and analytics on Procurement information

• Work with Procurement, Finance and business leaders to develop, enhance existing and develop new cross-functional Reporting capabilities

Temporary contract - 1 year, with possibility to become permanent

• University degree in Business, Finance, or Engineering
• 3+ years of experience:
  • with DWH/BI systems, within Finance, Invoice, Payments, Planning and Procurement subject areas
  • with ERP system mainly Procurement and Financial modules, structure and processes
• Strong knowledge Reporting and analytics solutions (Power BI, QlikView or similar) and understanding of IT acumen
• Strong knowledge of SQL/PL SQL with hands-on experience
• Experience with advanced analytics projects is an advantage
• Solid understanding of procurement best practices, policies and tools
• Exceptional MS office skills, along with the ability to manipulate heavy sets of data and create concise and accurate reports
• Strong interpersonal skills including cross-functional teamwork in multi-cultural environment.
• Effective written and oral communication skills
• Strong analytical and reporting skills. Managing data and information to report KPI’s and update progress against program objectives.
• Ability to lead and influence without authority
• Strong in time management and organization

The internal career site is available from your home network as well. If you have trouble accessing your EC account, please contact your local HR/IT partner.

UK, The Netherlands, Israel

• Analyze and map the professional capabilities of R&D teams to assess strengths and identify gaps at global level.
• Develop and implement comprehensive work plans to bridge competency gaps and enhance the skill sets of R&D employees.
• Identify synergies and shared capability needs across R&D functions, and design cross-functional development programs that address common gaps.
• Collaborate closely with R&D managers and the HR team to align capability development initiatives with business needs and organizational goals.
• Design targeted capability-building programs, ensuring they are aligned with the latest industry trends, technological advancements, and internal requirements.
• Monitor the progress and effectiveness of capability development initiatives, using data and feedback to continuously refine and improve strategies.
• Provide ongoing support and guidance to managers in developing their teams' skills and ensuring their professional growth aligns with R&D objectives.

• A bachelor's degree in a relevant field is required. A master's degree preferred.
• At least 5 years of experience in learning and development, or a related field, with a strong focus on capability mapping, skills gap analysis, and training program development.
• In-depth understanding of technical and professional capabilities development ideally within R&D environments, and the ability to analyze and develop tailored solutions to address competency gaps.
• Strong project management and organizational skills, with the ability to manage multiple initiatives and timelines effectively.
• An analytical mindset and data-driven approach, with the ability to identify gaps, develop solutions, and adapt strategies to meet evolving business needs.
• Proven ability to work cross-functionally with HR teams, managers, and other stakeholders to design and implement competency development strategies.
• Excellent written and verbal communication skills, with the ability to articulate complex concepts clearly and engage with employees at all levels.
• Fluent in English (written and verbal)
• Proven experience in global companies \ corporates with matrix organization

The internal career site is available from your home network as well. If you have trouble accessing your EC account, please contact your local HR/IT partner.

Actavis Laboratories FL, Inc. seeks a Regulatory Affairs Associate III responsible for the following:

· Review change controls for approved Abbreviated New Drug Applications (ANDAs), unapproved but submitted ANDAs, and make appropriate regulatory determination.

· Write, review and compile documentation and data necessary for submission of assigned PINDs, INDs, ANDAs and NDAs with limited supervision from manager.

· Write, review and compile documentation necessary for responses to FDA Deficiency letters.

· Write, review and compile documentation and data for Correspondences and post approval supplements.

· Review applicable revised and new regulations and guidance’s distributed by FDA.

· Train on internal SOPs (Standard Operating Procedure) and requirements as applicable.

· Assist in providing regulatory strategy for assigned R&D projects.

REQUIREMENTS:Bachelor’s degree (or foreign equivalent) in Life Sciences, Chemistry, or a related field.
Plus a minimum of 2 years of regulatory affairs experience, including:

• Solid oral dosage forms: tablets, hard gel capsules, softgel capsules, powders, granules, and pellets.
• Formulations: immediate-release, extended-release, delayed-release, complex generics (including peptides), and combination drug products.
• Regulatory submissions: P-INDs, INDs, NDAs, ANDAs.
• Responding to FDA deficiency comments and preparing submission responses.
• Regulatory advising for product launch readiness and post-approval changes.
• Familiarity with USFDA and ICH regulatory guidance.
• Experience with systems: Harmony Trackwise, VEEVA Vault (eCTD), Planisware, MS Word, PowerPoint, Excel.

We offer a competitive benefits package, including:

Comprehensive Health Insurance: Medical, Dental, Vision, and Prescription coverage starting on the first day of employment, providing the employee enrolls.

Time Off: Paid Time Off including vacation, sick/safe time, caretaker time and holidays.

The total compensation may also include restricted stock units and discretionary awards, depending on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment.

The internal career site is available from your home network as well. If you have trouble accessing your EC account, please contact your local HR/IT partner.

Within CPD Abbots Park, our work is organised into three product technology clusters, each broadly focused - though not exclusively - on a specific subset of injection devices:

• Cartridges & Pen Injectors
• Autoinjectors (AI)
• Pre-Filled Syringes & Safety Systems (PFS)

As Senior Device Engineer, reporting to one of the Engineering Team Leaders or to a Project Technical Lead, you’ll play a key role in ensuring our combination products are safe, effective, and compliant with global standards. You’ll apply best-practice engineering principles, Design Controls, and Safety Risk Management to guide products from concept through to production.

Your expertise in manufacturing technologies - such as plastic injection moulding - will be vital in preparing device designs for seamless transfer into production. You’ll bring creativity and problem-solving skills to tackle complex engineering challenges, while also contributing to the evolution of our departmental systems and influencing best practices across the team.

• Support the engineering design and development of drug delivery devices across various stages of development, including early research, design verification and validation, and life-cycle management.

• Ensure that products in your care are:
  • Engineered to be reliable and robust through the application of appropriate design, analysis, and testing methodologies.
  • Comprehensively specified, ready to be verified, and provide our submissions with objective evidence of compliance.
  • Documented in compliance with CPD’s Quality Management System.
• Lead or support Safety Risk Management activities, including:
  • Hazard identification.
  • Risk analysis and evaluation through the conduct of design Failure Modes and Effects Analyses (FMEAs).
  • Support to the Manufacturing, Science & Technology (MS&T) function in conducting process risk assessments.
• Lead or support technical design reviews to assess design robustness, safety, and documentation quality compliance.
• Lead or support investigations to identify root causes of device-related issues using established techniques such as Fault Tree Analysis and Design of Experiments.
• Contribute to the continuous improvement of departmental processes, including the development and maintenance of Standard Operating Procedures, guidelines, templates, and the introduction of new software tools.
• Mentoring and coaching capabilities, with the ability to support and guide junior colleagues as required.
• Responsible for the management of externally sourced engineering services, including oversight of associated budgets, timelines, and risk.
• Domestic and international travel may be required (approximately 10%) to support project activities, including visits to suppliers, Teva manufacturing sites, and other stakeholders.

Do You Have:

• Bachelor’s degree (or higher) in Engineering, Scientific, or other relevant Technical discipline.
• Proven experience in the design, manufacture, and life-cycle management of medical devices or combination products from concept through to commercialisation (preferred), or equivalent expertise from a relevant regulated industry.
• A demonstratable high level of independence in executing engineering tasks, with minimal supervision. Proactively identifies additional activities required and exercises sound judgement in seeking peer support when appropriate.
• Training in Design Controls, medical device Safety Risk Management, and European Medical Device Directive/Regulations (preferred).
• Familiarity with statistical methods relevant to design input definition, verification and validation testing, including the determination of sample sizes proportionate to risk.
• Strong 3D spatial awareness and ability to visualise concepts, mechanisms, and assemblies.
• Working knowledge of SolidWorks 3D CAD software (preferred).

Are You:

• Able to influence and educate peers and stakeholders; confident in professional judgement and decision-making.
• Bringing strong analytical skills with the ability to assess mechanisms and systems from a first-principles engineering perspective.
• Comfortable operating in dynamic environments, with the ability to adapt to change, manage uncertainty, and respond flexibly to evolving conditions.
• An effective verbal and written communication skills, including the ability to produce high-quality engineering documentation.

Whether you're growing your family or pursuing new adventures, our enhanced maternity and paternity leave, sabbaticals, and hybrid working policies are here to support you through life’s most meaningful moments. Financial wellbeing matters too, which is why we offer an enhanced pension scheme, access to a discount store, and free financial coaching through Bippit.

To help you grow with confidence, we offer a structured training and development programme tailored to your role and department, equipping you with the tools, knowledge, and support you need to thrive.

The internal career site is available from your home network as well. If you have trouble accessing your EC account, please contact your local HR/IT partner.