דרושים Senior Expert Regulatory Affairs ב-טבע ב-Bulgaria, Sofia

Teva Pharmaceuticals has been developing and producing medicines for more than 120 years. Along with our established presence in generics, we have significant research and operations supporting our growing portfolio of innovative medicines and biopharmaceutical products.

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• Actively participate in meetings related to registration procedures or when CMC expertise is needed.
• Collect and critically evaluate data for inclusion in marketing authorization dossiers.
• Compile module 3 and corresponding module 2.3 Quality Overall Summary (QoS) for presentation to regulatory authorities or clients, taking all necessary measures to ensure that dossiers meet relevant, current requirements and trends.
• Critically evaluate the content of module 2.3 and module 3 in terms of completeness and relevance for supporting a new registration and respond to queries.
• Actively participate in the change control system and work in line with established processes.
• Prepare the variation packages and other necessary documents as required by the variation process
• Perform regulatory evaluation and assessment of technical documentation
• Contribute to renewal applications or annual reports
• Keep up to date with regulatory and other developments in the pharmaceutical industry, including relevant legislation and guidelines (EU, US and International markets) and pharmacopoeias.
• Support strategic projects such as technical transfers.
• Ensure that all documents and records pertaining to the RA CMC Lifecycle Department are archived properly. Keep departmental database or other tracking systems up to date.

• University degree, preferably be in possession of a master level of education in ‘Regulatory Disciplines’ or in other area, but pertinent with the field.
• 2-5 years of experience in CMC Regulatory Affairs or in another scientific role in the pharmaceutical industry.
• Knowledge on registration procedures and pharmaceutical regulation.
• Working independently with a moderate level of guidance and direction.
• Very good command of English, speaking and writing.
• Good IT skills.
• Ability to work in team.
• Communication skills with internal and external customers.
• Organisation skills.
• Accuracy in practice and attention to detail.

• Dynamic and challenging work environment in one of the world leading pharmaceutical company and the biggest pharmaceutical company in Bulgaria
• Competitive remuneration bound with performance
• Additional healthcare insurance
• Transportation allowance and other flexible benefits
• Flexible working hours and option to work from home as per the company policy
• Opportunity for development

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.

• Requirement Analysis: Analyze business requirements and perform thorough Impact analysis
• Solutioning & Design: Solutioning for new SAC (SAP Analytics Cloud) planning application implementations and also for enhancements to existing planning applications.
• Prepare High level and detailed design specifications related to SAC Planning model and Import/Export interfaces from/to SAP BW/Datasphere/Oracle databas
• Collaboration: Collaborate with Technical, Stakeholder management and Cross functional teams
• Delivery : Contribute and lead the delivery of SAC Planning application Implementation, enhancements and Interface developments
• Project Status updates : Timely updates of the ongoing development tasks and incident resolution status to the management and concerned teams
• Technical Ownership : Assume technical ownership ensuring tight control over all the technical aspects of the application and adhering to established governance and best practices
• Project Support: Monitor Service Now incidents, JIRA tasks and track them to closure
• Technical Documentation: Prepare and maintain the technical documentation and user guides

• : Bachelor's or Master's degree in Finance, Accounting, Business Administration, or Information Technology.
• 12 + years of experience in the areas of Planning and Analytics
• Minimum 3-4 end to end Planning/Budgeting/Forecasting implementation experience using SAC (SAP Analytics Cloud) Planning
• Strong Understanding and experience of implementing Financial Planning and Standard Financial statements : P&L, Balance Sheet and Cash Flow is a must
• Experience in developing Advanced formula, Data actions
• Extensive experience in Stories and dashboards with rich visualization.
• Experience with setting up User Security in SAC
• Experience with Inbound and Outbound data integrations/interfaces with upstream and downstream systems is a must
• Experience with scripting for Analytical applications is an added advantage
• Strong excel skills
• Data reconciliation and troubleshooting skills
• Hands-on experience with SAP BW / SAP Datasphere
• Hands-on experience in developing simple to Medium complexity SAP HANA Calculation views
• Good Understanding / Hands-on experience in SQL is an added advantage
• Past experience in other Planning tools like BPC standard, BPC Embedded , BW-IP, Hyperion Planning etc. is an added advantage
• Client interfacing skills and experience in interfacing with Senior management and Business users/end users
• Self motivated and quick learner and has the ability to adapt to highly dynamic environment

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 an, you will oversee a team responsible for managing the end-to-end regulatory artwork process for pharmaceutical and non-pharmaceutical products across Europe. In addition to your leadership responsibilities, you’ll remain actively involved in daily operations—ensuring high-quality service delivery and compliance with regulatory standards.

• Lead and support a team of Artwork Coordinators Markets, ensuring effective workload distribution and team development
• Oversee the end-to-end regulatory artwork process, including initiation, review, and approval of packaging artworks
• Actively contribute to daily operations (approx. 50% of the role), maintaining hands-on expertise and supporting peak periods
• Collaborate with internal stakeholders across markets, artwork studios, and regulatory teams to ensure timely and compliant delivery
• Monitor team performance, identify improvement opportunities, and contribute to process optimization initiatives

• Higher education in Life Sciences, Healthcare, Business Administration, or a related field
• 3+ years of relevant experience, including 1–2 years in a leadership role
• Strong organizational, communication, and stakeholder management skills
• Proficiency in Microsoft 365 and experience with document management systems
• Advanced English; additional languages are a plus
• Strong compliance awareness

• Dynamic and challenging work environment in one of the world leading pharmaceutical company and the biggest pharmaceutical company in Bulgaria
• Competitive remuneration bound with performance
• Additional healthcare insurance
• Transportation allowance and other flexible benefits according to the company policy
• Flexible working hours and option to work from home as per the company policy
• Opportunity for development

Please, kindly note that only shortlisted applicants will be contacted. All personal data is protected by law and will be treated in confidence.

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.

Teva Pharmaceuticals has been developing and producing medicines for more than 120 years. Along with our established presence in generics, we have significant research and operations supporting our growing portfolio of innovative medicines and biopharmaceutical products.

• Creation and Maintenance of Master data
• Acting as a commercial intermediary between Teva sites and Internal and External customers regionally and globally
• Collaboration with all international teams, sites and markets in order to provide solution for any occurred problems
• Managing the end to end execution from order placement till delivery and ensures best practice in Logistics and Inventory monitoring processes
• Managing customer service issues and facilitating discussions for resolution
• Performing management reporting
• Participation in/Leading Projects and workshops
• Training new colleagues when needed

· Bachelor Degree or equivalent (preferably in business management discipline)
· Minimum 2 years of experience in an international business environment
· Excellent communication skills in English
· Knowledge of MS Word, MS Excel, MS Outlook
· ERP experience - SAP or other business management system
· Understanding of pharmaceutical business and/ or knowledge of PowerPoint and Visio would be an advantage

• Dynamic and challenging work environment in one of the world leading pharmaceutical company and the biggest pharmaceutical company in Bulgaria
• Competitive remuneration bound with performance
• Additional healthcare insurance
• Transportation allowance and other flexible benefits
• Flexible working hours and option to work from home as per the company policy
• Opportunity for development

Please, kindly note that only shortlisted applicants will be contacted. All personal data is protected by law and will be treated in confidence.

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.

ESSENTIAL AREAS OF RESPONSIBILITY

The following areas of responsibility are essential to the satisfactory performance of this position by any incumbent, with reasonable accommodation if necessary. Any nonessential functions are assumed to be included in other related duties or assignments.

• Quickly build rapport and personable relationships with HCPs, medical staff, and key decision-makers within accounts and with stakeholders and cross-functional partners within Teva
• Provide healthcare product information to physicians, office staff, and key decision-makers within accounts
• Work to uncover HCP and staff challenges and develop solutions, provide resources, or connect cross-functional colleagues to meet customer needs
• Demonstrate the effort and hustle necessary to meet or exceed customer expectations
• Facilitate product and script pull through by working to solve prescriber challenges, interfacing with specialty or facility pharmacies, and connecting cross-functional colleagues to solve problems and provide solutions
• Remain apprised of all product formulary developments within facilities
• Work with the discharge coordinator to understand patient follow-up treatment and transitions of care
• Work to understand the perspectives, challenges, and needs of HCPs, influential stakeholders, and decision-makers within accounts and adapt messaging, tactics, and strategy to influence their prescriber habits
• Work to navigate accounts by uncovering and understanding key decision-makers, how different entities work together, different prescribers and their schedules, and the intricacies of different accounts
• Take initiative to lead business in an independent manner and take accountability for delivering results and meeting sales goals within their accounts
• Engage in pre-call planning to identify goals, consider intricacies of accounts, and create effective plans that are tailored to the unique needs of the account and specific customer
• Effectively manage time by understanding available opportunities and challenges, maximizing effectiveness with fewer touchpoints, planning routing to maximize call points within different areas of geography, and adjusting priorities based on changing dynamics
• Maintain a hunter mentality and competitive drive with a willingness to go above and beyond role expectations to exceed goals and targets
• Develop effective business plans that meet and exceed sales goals by gathering, analyzing, and evaluating relevant market, territory, and competitive data and trends to inform business planning and strategy, and to understand current performance
• Work to understand the broader organizational vision, strategy, and values and use them as guideposts for conducting day-to-day activities
• Proactively seek opportunities to collaborate and communicate with counterpart sales reps from other sales teams and with individuals both within and outside their immediate team, and maintain a One Teva mindset

Proactively share knowledge, ideas, and best practices with cross-functional partners and demonstrate openness to others' ideas

POSITION REQUIREMENTS

Any equivalent combination of education, training, and/or experience that fulfills the requirements of the position will be considered.

Education/Certification/Experience

• Bachelor’s degree required
• Minimum of 5 years of pharmaceutical sales experience required, preferably in the psychiatry or long-acting injectable schizophrenia space
• Experience in the hospital setting or long-term care setting with a detailed understanding of the buy-and-bill model, formulary placement, P&T committees, and in-services required
• Experience in psychiatric therapeutic areas strongly preferred
• Specific experience with long-acting injectables and in-office administration for the treatment of schizophrenia in the hospital setting or long-term care setting preferred
• Experience successfully launching products in the psychiatric space across multiple settings of care
• Ability to operate within complex settings and networks and provide customer insights effectively

Skills/Knowledge/Abilities

• Ability to interact with customers in live and virtual environments and proficiency with technology
• Understanding of reimbursement coverage and pull-through strategies as well as experience in all pertinent settings of business (CMHC, specialty pharmacy, private practice)
• Understanding of the buy-and-bill model
• Leadership skills and ability to collaborate with multiple sales teams
• Proven written and verbal communication skills
• Demonstrated interpersonal skills
• Valid US driver’s license and acceptable driving record required
• Candidate must be able to successfully pass background, motor, and drug screening

TRAVEL REQUIREMENTS

Regular travel, which may include air travel and weekend or overnight travel

The annual starting salary for this position is between $88,000 – $170,000 annually. Factors which may affect starting salary within this range and level of role may include geography/market, skills, education, experience and other qualifications of the successful candidate.

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.
• Retirement Savings: 401(k) with employer match, up to 6% and an annual 3.75% Defined Contribution to the 401k plan.
• Time Off: Paid Time Off including vacation, sick/safe time, caretaker time and holidays.
• Life and Disability Protection: Company paid Life and Disability insurance.
• Additional benefits include, but are not limited to, Employee Assistance Program, Employee Stock Purchase Plan, Tuition Assistance, Flexible Spending Accounts, Health Savings Account, Life Style Spending Account, Volunteer Time Off, Paid Parental Leave, if eligible , Family Building Benefits, Virtual Physical Therapy, Accident, Critical Illness and Hospital Indemnity Insurances, Identity Theft Protection, Legal Plan, Voluntary Life Insurance and Long Term Disability and more.

This position is ultimately organizationally and functionally subordinated to the Global Head of Compliance Audit within the Global Internal Audit Group and is designed to provide for optimum independence and objectivity.

• Responsible for assisting the overall Global Internal Audit department in the establishment of a program for compliance and financial auditing based upon direction from Global Head of Compliance Audit.
• Responsible for the performance of audit procedures in accordance with the annual compliance internal audit work plan or at the direction of the Global Head of Compliance Audit or Compliance Audit team leaders.
• Responsible for the design and delivery of meaningful, accurate and effective presentations to local, regional and global senior management and ensure follow-up on any areas that require corrective action. This role is also responsible for the performance of ongoing follow-up of the implementation of the recommendations of the auditor’s reports and shall draw the attention of the general management of the country being audited for delays in the rectification of deficiencies that have been found in the past.
• Serve as subject matter expert and provide expertise and advice to regional business partners regarding compliance and financial issues. Partner with regional Legal, Finance, and Global Compliance, in carrying out compliance and financial audit activities.
• Maintain all organizational and professional ethical standards and ensures internal audit activities are carried out in compliance with the IIA’s International Standards for the Professional Practice of Internal Auditing (Standards) and department and company policies and procedures.
• Works independently with extensive latitude for initiative and independent judgment.

• Bachelor’s degree in Accounting or related business discipline (i.e. law, criminal or forensic sciences, IT, etc.).
• Minimum of three (3) years of full-time experience in internal audit, external audit, law or Compliance.
• Big 4 Accounting Firm, and/or international Compliance experience with emphasis on Compliance specific to PhRMA Code and FCPA including Anti-Corruption and Anti-Bribery, and experience within Pharmaceutical/Life Sciences industry.
• Professional certification (i.e. CPA, CMA, CIA, CFE, CISA, CRMA, CRISC, CSA, etc.) Other certifications in related field are also a plus.
• Advanced skills in collecting and analyzing complex data, evaluating risk, drawing logical conclusions and presentation of results.
• Knowledge of and skill in applying audit principles and practices, preferred business practices and concepts, and common indicators of fraud; in global operations within the pharmaceutical industry.
• Ability to travel extensively internationally (approx. 25%)
• Advanced level of English – both written and spoken

• Dynamic and challenging work environment in one of the world leading pharmaceutical company and the biggest pharmaceutical company in Bulgaria
• Competitive remuneration bound with performance
• Additional healthcare insurance
• Transportation allowance and additional flexible benefits
• Flexible working hours and option to work from home as per the company policy
• Opportunity for development

Please, kindly note that only shortlisted applicants will be contacted. All personal data is protected by law and will be treated in confidence.

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.

• Planning, preparing, submitting post-approval variations in line with the corporate procedures
• Provide input into regulatory strategies and process improvement/compliance activities within defined areas of scope.
• Analyse regulatory issues and communicate with key stakeholders.
• Maintaining of the relevant regulatory tools
• Keeping up to date with regulatory legislation
• Maintaining communication pathways with all relevant internal stakeholders and external contacts Regulatory Affairs, Local Affiliates, Business Development, Contract Management, IP, Marketing, Core Teams, Portfolio, Manufacturing sites, QA, Authorities, consultants, etc.

• MSc/PhD in Life Science, Pharmaceutical or equivalent university degree
• Experience in regulatory or pharmaceutical industry
• Solution and result oriented attitude
• Good organizational and good communication skills
• High level of written and spoken English

• Dynamic and challenging work environment in one of the world leading pharmaceutical company and the biggest pharmaceutical company in Bulgaria
• Competitive remuneration bound with performance
• Additional healthcare insurance
• Transportation allowance and other flexible benefits according to the company policy
• Flexible working hours and option to work from home as per the company policy
• Opportunity for development

Please, kindly note that only shortlisted applicants will be contacted. All personal data is protected by law and will be treated in confidence.

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.