Instagram
youtube
Facebook

Sr Mgr Regulatory Affairs

12+ years
Not Disclosed
10 July 28, 2025
Job Description
Job Type: Full Time Education: Master’s or Ph.D. Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

 

Senior Manager – Regulatory Affairs (EU Labeling) – Teva Pharmaceuticals, Bangalore

Job Summary:

Teva Pharmaceuticals is hiring a Senior Manager – Regulatory Affairs to lead its EU Labeling division in Bangalore. This is a full-time, on-site leadership role focused on ensuring regulatory compliance and strategic labeling for generic, biosimilar, and innovative pharmaceutical products across the European market. With over 12 years of experience in Regulatory Affairs and at least 3 years in leadership, the ideal candidate will oversee complex regulatory operations, cross-functional team management, and ensure global compliance in product labeling and pharmaceutical regulations.


Key Responsibilities:

  • Lead the EU labeling team, overseeing departmental tasks and project management

  • Develop and execute regulatory strategies for innovative and generic products

  • Ensure compliance with EU regulations across all product information (SmPC, PIL, labeling)

  • Coordinate SOP development, budgeting, and departmental resource planning

  • Monitor safety updates and legal changes affecting labeling and packaging

  • Support Pharmacovigilance-triggered updates in collaboration with QA and PV teams

  • Respond to EU authority inquiries and deficiency letters

  • Lead cross-functional collaboration on product strategy and lifecycle updates

  • Participate in industry representation and working groups (e.g., Medicines for Europe)


Required Skills & Qualifications:

  • Minimum 12+ years of total experience, with at least 8 years in regulatory affairs (medicinal information & EU labeling)

  • Minimum 3 years of leadership experience in pharmaceutical or life sciences settings

  • Master’s or Ph.D. in Pharmacy (preferred), Biology, Human Biology, Medicine, or Food Chemistry

  • Strong understanding of EU pharmaceutical law, labeling requirements, and safety update protocols

  • Proficiency in MS Office, project management, and regulatory documentation

  • Advanced English communication (spoken & written)

  • Strategic, diplomatic, and detail-oriented leadership skills


Perks & Benefits:

  • Competitive compensation and leadership incentives

  • Global exposure to EU regulatory frameworks and pharmaceutical markets

  • Access to professional growth through complex project leadership

  • Work with a purpose-driven team improving global healthcare

  • Inclusive, diverse, and collaborative workplace culture

  • Opportunity to influence regulatory strategies across international markets


Company Description:

Teva Pharmaceuticals is a global leader in generic and specialty medicines, committed to improving health and access to affordable therapies worldwide. With operations in over 60 countries and a strong presence on the World Health Organization’s Essential Medicines List, Teva’s innovations help over 200 million people daily.


Work Mode:

On-site – Bangalore, India


Call-to-Action:

If you’re a regulatory affairs leader with a passion for global pharmaceutical compliance and strategic labeling, apply now to join Teva’s mission of making good health more affordable and accessible.