Sr Mgr Regulatory Affairs

Who we are

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

1. 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.
2. Team Leadership
• Organize and coordinate team tasks, personnel management and planning.
• Plan team activities and align with other teams.
3. 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.
4. Monitoring
• Monthly monitoring and communicating safety updates from EU authority websites.
• Track reference product updates and legal/guidance changes affecting product information.
5. 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).
6. 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.
7. Mock-ups
• Coordinate creation and approval of packaging mock-ups, Braille, and specimens.
• Address authority queries and ensure compliance with EU regulations.
8. 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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