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Sr Mgr Regulatory Affairs

12 - 22 years

25 - 30 Lacs

Bengaluru

Posted:10 hours ago| Platform: Naukri logo

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Skills Required

Project management Pharmacy Personnel management Packaging Strategic planning Pharmacovigilance MS Office Regulatory affairs Monitoring Recruitment

Work Mode

Work from Office

Job Type

Full Time

Job Description

Find a Career With Purpose at Teva
Keyword
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Select how often (in days) to receive an alert: Sr Mgr Regulatory Affairs
Date: Jul 18, 2025
Location:
Bangalore, India, 560064
Company: Teva Pharmaceuticals
Job Id: 62865

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

  • 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.
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 is committed to equal opportunity in employment. It is Tevas global policy that equal employment opportunity be provided without regard to age, race, creed, color, religion, sex, disability, pregnancy, medical condition, sexual orientation, gender identity or expression, ancestry, veteran status, national or ethnic origin or any other legally recognized status entitled to protection under applicable laws. We are committed to a diverse and inclusive workplace for all. If you are contacted for a job opportunity, please advise us of any accommodations needed to support you throughout the recruitment and selection process. All accommodation information provided will be treated as confidential and used only for the purpose of providing an accessible candidate experience.

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