המקום בו המומחים והחברות הטובות ביותר נפגשים
Teva Sr Mgr Regulatory Affairs Mexico, Guanajuato 42423077
28.07.2025
The opportunity
- Ensure 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 for internal and authority-related inquiries and problem-solving.
- Ensure regulatory compliance for all maintained innovative, biosimilar and generic EU procedures (MRP, DCP, CP) regarding labeling.
- Support team members with complex issues as a senior expert (especially in responsibilities 2–6).
- Lead a team of academic staff and administrative staff handling EU Labeling and support departmental leadership.
How you’ll spend your day
- Department Leadership
- Organize and coordinate departmental tasks, personnel management, and planning.
- Manage budget and resource planning.
- Establish efficient internal and cross-departmental processes.
- Lead projects related to labeling, including project management.
- Review and approve SOPs for the department and overall processes.
- Support division leadership and develop strategy, principles, and guidelines.
- Team Leadership
- Organize and coordinate team tasks, personnel management and planning.
- Plan team activities and align with other teams.
- Labeling
- Responsible for creating and updating compliant English product information for EU procedures.
- Strategic planning and implementation of changes affecting multiple product information documents.
- Determination of an implementation plan and tracking the implementation of updates due to new requirements (e.g. new excipients warnings, QRD template update)
- 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.
- Monitoring
- Monthly monitoring and communicating safety updates from EU authority websites.
- Track reference product updates and legal/guidance changes affecting product information.
- 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).
- Scientific Work & Authority Communication
- Participate in project teams to fix the regulatory strategy and prepare expert statements.
- Respond to authority deficiency letters in collaboration with other departments.
- Mock-ups
- Coordinate creation and approval of packaging mock-ups, Braille, and specimens.
- Address authority queries and ensure compliance with EU regulations.
- Industry Representation
- Participate in working groups (e.g., Medicines for Europe) to represent the company as an EU labeling expert.
Your experience and qualifications
- Experience: 12+ years of total experience and minimum 8 years in relevant fields (medicinal information and EU labeling in the pharmaceutical industry), ideally in Regulatory Affairs with at least 3 years of leadership experience.
- Education: Completed at least 8-semester university degree in natural sciences (e.g., Pharmacy [preferred], Biology, Human Biology, Medicine, Food Chemistry), preferably with a Ph.D. Additional leadership qualification is preferred.
- Other: Advanced English (spoken and written), strong MS Office skills, excellent knowledge of EU pharmaceutical law, regulatory affairs, and related legal areas. Project management experience required.
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