דרושים Regulatory Affairs Associate Ii ב-טבע ב-India, Bengaluru

Providing regulatory support for International Markets RA.

• Completion of designated projects and tasks supporting International Market RA, according to internal Work Instructions, with guidance and direction by the manager and more senior colleagues.
• Maintaining related documentation and regulatory IT systems, in line with internal procedures.
• Timely task completion in line with Work Instructions, with accurate tracker updates and adherence to compliance standards.
• Communication with Teva units across International Markets, with 3rd Parties and with related Health Authorities.
• Fulfilling other allocated department duties and ad-hoc tasks as directed by senior regulatory affairs staff.
• Completion of trainings assigned in Teva internal learning management system within defined timeframes.
• Attending team meetings and providing regular updates on the assigned activities and tasks to the manager and/or to senior regulatory affairs staff.
• Maintaining and developing awareness of the current/pending regulatory legislation and guidelines.

Qualification:

• Masters in Pharmacy or Masters in Science/Life Sciences
• College or University degree or equivalent work experience that provide knowledge of and exposure to fundamental theories, principles and concepts.

Experience:

• 2-3 years of experience in the Pharmaceutical Industry, ideally within Regulatory Affairs but R&D, Development or QA would be considered.
• Experience of regulatory documentation within Europe and/or International Markets.

• Work experience involving core regulatory concepts and procedures.
• Ability to use existing internal procedures to solve routine or standard problems.
• Proficient in regulatory IT systems to support compliance and documentation processes.
• Working knowledge of Office-365 applications and Veeva Vault systems.
• Strong focus on Compliance and regulatory standards.
• Basic knowledge of project management principles and tools.
• Strong organizational skills to meet self, team and company goals.
• Ability to identify a problem or need for decision that exceeds the competence of the individual.
• French and/or German language proficiency will be an added advantage.

• Monthly review of Health Canada brand safety updates.
• Align updates with internal product lists and communicate relevant changes to cross-functional teams.
• Strategize and implement changes impacting multiple product documents.
• Track and retrieve the latest innovator PMs from the Health Canada Drug Product Database.
• Create and update Teva PMs by referencing Canadian innovator products.
• Use tools like TVT for document comparison, ensuring compliance with HC master templates.
• Perform thorough QC, editing, formatting, and coordinating the review and approval processes.
• Collaborate with French translators for bilingual PMs.
• Coordinate with artwork team the creation of packaging components (Inserts/Outserts/Cartons/Labels) for sANDS submissions.
• Manage the Veeva Artwork Process to obtain final artworks.
• Conduct quality reviews of labeling and submission documents using manual proofreading and electronic tools (TVT).
• Support other safety Level III updates and regulatory commitments in collaboration with the Canada RA team.
• Address Health Canada queries including clarifaxes, screening acceptance, pause-the-clock requests, extensions, BA/BE queries, and withdrawals.
• Maintain accurate project trackers to monitor due dates, priorities, and timelines for all assigned projects.
• Keep databases updated and share current PMs and relevant details with internal and external stakeholders.
• Collaborate with the RA Canada team on safety-related submissions such as Advisement Letters and Level III changes.
• Ensure timely eCTD-compliant submissions in coordination with Regulatory Operations and publishing software.
• Stay current with Health Canada regulations, guidelines, and SOPs.
• Work effectively in a team environment with minimal supervision.
• Perform additional job-related duties as required by management and evolving processes.

• Pharma Graduate / Post Graduate with a Scientific or Regulatory background or equivalent combination of education and experience
• 3+ years of experience in Regulatory Affairs with a focus on Canadian labeling.
• Knowledge of Health Canada regulatory requirements related to Canadian labeling
• Knowledge of XML/SPM development and Health Canada requirements.

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.

This incumbent

• Ensures that the review of CMC documentation is completed in timely & compliant manner as per Teva CORP standards and related Guidance’s.
• Review of Method Development/Validation Protocols & Reports, Stability Protocols & Reports received from various Teva contracting sites, R&D units, Method Development & Stability Testing Centres.
• Review of Instrument/Equipment Qualification records.
• Review of BMR.
• Ensures that the Product Quality Reviews / Annual Product Reviews for Teva products are completed in a timely and compliant manner as per Teva’s CORP Quality Management systems. PQR/APR compilation and approval must be well associated with the Teva Manufacturing Sites, Global Quality Units and Commercial affiliates to meet the targets and ensure compliance.
• Compilation of high quality Annual Product Reviews (APRs) / Product Quality Reviews (PQRs) for products manufactured at various manufacturing sites and retrieve data from the Quality and regulatory databases and system
• Liaising with third party contract manufacturers and QA/QC/Technical support personnel located globally for data collection and arranging responses.
• Recommend actions and professionally communicate to sites/ Quality units for continuous improvement in quality of products
  Receives guidance from Supervisor, Group Leader, Manager Global Quality Services, Associate Director Global Quality GBS, other Managers in Quality Strategy & Shared Services, EMSO Quality affiliates, Commercial Quality EU & IM, TGO sites

1. Review of CMC Documentation

• Review of Method Development / Validation protocols & reports.
• Review of Stability Study protocol, reports & grids.
• Review of Instrument / Equipment Qualification records.
• Review of Batch Manufacturing Records.
• Liaising with contracting Teva units and QA/QC personnels located globally for arranging required documents and query responses.
• Escalation of issues to Supervisor, Group Leader, Manager Global Quality GBS.
• Contemporaneous updation of SharePoint data base

1. Data requesting and Compilation of PQR’s

• Compilation of high-quality Annual Product Reviews (APRs) / Product Quality Reviews (PQRs) for products manufactured at various manufacturing sites and retrieve data from the Quality and regulatory databases and systems
• Liaising with third party contract manufacturers and QA personnel located globally for data collection required for compilation of APRs/ PQRs.
• Follow up with the CMO‘s for the receipt of data within time.
• Check quotation received from CMO and initiate PR/PO for QP’s approval.
• Once the data is received responsible for filling the PQR receipt checklist and scheduling the PQR in SharePoint.
• Escalation of PQR issues to Supervisor, Group Leader, Manager PQR Centre.
• Contemporaneous updation of SharePoint data base

1. Quality Management Systems

• Initiate the process of change controls and deviations
• Preparation of local SOP’s and its related documents.
• Participate in self-inspection process

1. Performance Management

• Participate in continuous process improvement projects to improve efficiency of the unit

1. Training

• Prepare the Training Materials for GMP training and on the job training.
• Imparts training on procedures as needed.

1. Miscellaneous Support

• Any other tasks assigned by the management for smooth functioning of the team

• 2 to 8 years of experience in QA / QC function in the pharmaceutical industry
• Master’s Degree in Pharmacy or other natural sciences or Bachelor Degree in Pharmacy or other natural sciences
• Basic knowledge on worldwide cGxP regulations
• Good English language skills, other language skills could be helpful
• Good communication skills
• Basic knowledge of Computerised Systems. Knowledge of Systems in TEVA´s IT landscape (TrackWise, SAP, LIMS, Global Insights, Glorya etc.) would be of advantage
• Basic understanding of manufacturing, QC and Contract manufacturing processes
• Engagement to drive improvements and ability to manage complexity
• Hands-on experience on Analytical Method development, Method Validation for API and FP of different analytical methods (e.g. Assay, impurities, dissolution etc.) & Stability Studies.
• Hands-on experience on Review of Instrument/Equipment qualification records.
• Basic knowledge / hands on experience of review of BMR.
• Basic knowledge / hands on experience on Product Quality Reviews.

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.

• Build rapport and relationships by interacting effectively with regional team members and key external contacts (ie, HCP and entire office staff) at all levels, demonstrating the awareness of their needs and responding with the appropriate action
• Provide healthcare product demonstrations, physician detailing, and in-servicing of products to current and potential customers
• Consult with physicians, nurses, and medical office staff to appropriately promote product and provide product and patient education
• Strategically manage and grow relationships with key accounts by tailoring solutions to meet their unique needs, leveraging industry insights to drive product differentiation and achieve sales targets
• Regularly review and analyze all provided sales data in order to create effective territory plans and utilize promotional budget funds
• Maintain a competitive edge by effectively addressing external market challenges while fostering a collaborative environment with internal teams to drive cohesive and successful sales strategies
• Open to working with cross-functional teams to integrate diverse expertise and insights and achieve shared objectives
• Maintain a call average as outlined in the sales plan, defined as face-to-face interactions, with healthcare providers focusing on top target customers
• Take calculated risks and apply a range of traditional and nontraditional problem-solving techniques to solve issues creatively in order to improve performance in geographical assignment
• Adhere to all Teva’s compliance policies and guidelines
• Achieve all sales performance goals, reach objectives, and complete all administrative duties for geographical assignment

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, preferably in related field
• At least 1 year of full-time, documented business-to-business sales experience; pharmaceutical sales experience strongly preferred

Skills/Knowledge/Abilities

• Proven record of accomplishments in this specific market toward meeting established objectives
• Demonstrated interpersonal skills, including active listening, empathy, open communication, inclusivity, and openness to feedback
• Well-developed written and oral communication skills
• Ability to interact with HCPs in both face-to-face and virtual environments, and be proficient with technology
• Knowledge of reimbursement, managed care, or marketing preferred
• New product launch experience preferred
• Broad therapeutic area experience particularly in therapeutic area preferred
• Candidate must be able to successfully pass background, motor, and drug screening
• Valid US driver’s license and acceptable driving record required

Full time documented business to business sales experience dependent on level as listed below. Pharmaceutical sales experience preferred. Level of the role will be commensurate to years of experience and performance criteria.

• Sales Specialist : Minimum 1 year
• Executive Sales Specialist : Minimum 7 years

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.

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.

• Ensure the pharmaceutical, medical, and regulatory accuracy of English product information (SmPC, Labeling, PIL) for European procedures (MRP, DCP, CP) of innovative, biosimilar and generic products.
• Provide internal pharmaceutical and medical expertise to address internal and authority-related inquiries and resolve labeling issues.
• Ensure regulatory compliance for all maintained innovative, biosimilar and generic EU procedures (MRP, DCP, CP) regarding labeling.

1. Labeling
• Responsible for creating and updating compliant English product information for EU procedures.
• Providing instructions and guidance to local RA (e.g. calculations due to new excipients warnings).
• Discussion of the content of product information for innovative products (pre- and post-approval) in project teams.
• Evaluate and approve change requests; coordinate submissions with EU regulatory units.
• Collaborate on patent-related issues with Global IP Group.
• Contribute to readability studies and ensure PIL readability and compliance with legal requirements.
• Adaption to reference medicinal product (generic, hybrid, biosimilar procedures).
• Preparation of Expert statements (justification) for type II variations.
• Providing scope of variation to regulatory affairs.
• Performing plausibility check and providing wording to be in line with QRD requirements and Standard Terms for module 3 updates.
2. Monitoring
• Monthly monitoring and communicating safety updates from EU authority websites.
• Track reference product updates and legal/guidance changes affecting product information.
3. Pharmacovigilance
• Assess need for updates based on Company Core Safety Information (CCSI).
• Implement PV triggered and non-PV triggered safety updates (e. g. PRAC/PSUSA/PSUFU, Referrals (Articles 31 + 107i), article 30 procedures, etc.) in line with SOPs; collaborate on safety-related actions with Pharmacovigilance and QA.
• Participation in Product Safety Group (PSG) Meetings.
• Implementation of internal signals (including determining PIL wording).
4. Scientific Work & Authority Communication
• Respond to authority deficiency letters in collaboration with other departments.
5. Mockups
• Coordinate creation and approval of packaging mockups, Braille, and specimens.
• Address authority queries and ensure compliance with EU regulations.

• Experience: 5 to 6 years in relevant fields, (medicinal information and EU labeling in the pharmaceutical industry) ideally in Regulatory Affairs.
• Education: Completed at least 8-semester university degree in natural sciences (e.g., Pharmacy [preferred], Biology, Human Biology, Medicine, Food Chemistry)
• Other: Advanced English (spoken and written), strong MS Office skills, knowledge of European Pharmaceutical Law and Regulatory Affairs.

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.

• Management of the submission and approval process for Teva products in APAC Region (Australia, New Zealand, Singapore, Malaysia etc) to support business opportunities for the company.
• Management of regulatory compliance including product maintenance, data sheets, labelling, regulatory compliance files and regulatory databases.
• Support new product launch activities including coordinating regulatory requirements, artwork approval and providing technical input into any product related materials required for market introduction.

Regulatory Submissions

• Manage all submissions and maintenance activities related to Branded/Specialty and Generic products in APAC region.
• Ensure full compliance of marketed products according to local regulations by proactively managing and monitoring change control with sites/suppliers and global RA WP. Manage local regulatory planning process for post-approval changes, including variations, site transfers and compliance related activities to support supply continuity.
• Manage activities within Regulatory Systems and keep up to data as per compliance requirements (GRIDS, GI Insights, Teva Art, Veeva etc)

Regulatory Intelligence/Expertise/Guidance/Education

• Provide regulatory guidance to ensure that Teva can meet the responsibilities of an importer, distributor and sponsor, to ensure supply of safe and effective medicines, including supply of unapproved medicines, as required by Health Authorities
• Provide regulatory intelligence and maintain thorough and up-to-date understanding of the regulatory environment in APAC region by providing impact analysis feedback to commercial teams..
• Capture monthly activities via reports and capture RA activities on an ongoing basis in the regulatory tracking system.
• Ensure regulatory records and files are maintained electronically for ready record retrieval and life cycle management, in accordance with global and local requirements.
• Monitor, collect and interpret regulatory guidelines and trends that will impact marketed and planned products, share this information with appropriate personnel and assist in the development of strategies and plans of action to address them.
• Work closely with market RA in APAC region to complete all assigned activities

• B. Pharm / M. Pharm (preferred) with 10+ years of experience
• Good knowledge and understanding of pharmaceutical & scientific processes as well as registration and assessment of human medicinal products and medical devices.
• Experience in Generics, Biosimilars or Innovative Medicines in Regulatory Affairs (APAC preferred) and knowledge of regulatory and healthcare system in APAC (Australia, New Zealand, Singapore, Malaysia etc)

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.

• Managing all Labor Costing related accounting activities including Planning process and their reporting and reconciliations.
• Plays key role in the initial transition of processes in cost of labour planning activities into the Global Business Services. Therefore, tight communication and collaboration with local, regional and global accounting, FP&A, HR teams where needed.
• Standardize and streamline cost of labour planning process with clear methodology across all sites and BU’s;support local planners with queries and training on the proper usage of the CoL SAC planning platform.Build robust monthly recon process, run sanity checks on system output vs historical data etc.
• Understand and ensure adherence with applicable financial policies and guidelines with special emphasis on:CoL planning guidelines, global accounting policies, corporate FP&A and HR policies and AOP guidelines.
• Be fully accountable for all the CoL planning activities- plan, report, monitor and analyze.
• Perform regular scrutiny of ledgers, to ensure accuracy of general ledgers, cost center & profit center accounting.
• Support business decisions by providing ad hoc analytics and assessments for differentscenarios.
• Maintain analytical processes, routines and tools to support CoL analysis and validation.

SKILLS/QUALIFICATIONS:

• 5 to 7 years of relevant experience with finance background with strong working knowledge in financial planning, costing and cost of labor accounting.
• BCom/ M.Com / BBA/BBM /MBA Finance
• Strong analytical skills with the ability to collect, organize and analyze significant amounts of information with attention to detail and accuracy
• Workig experience in SAP Sucess Factors & SAP Analtyics on Cloud (SAC) prepered
• Excellent Excel capabilities
• Previous Work Force planning / Cost of Labour experience - advantage
• Fluent verbal and written communication in English
• Excellent collaboration with colleagues in the organization
• Ability to work effectively under pressure
• Location is based in Bangalore with Work from Office Culture
• Ability to travel within & outside India when required

Flexibility to work in shifts

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.