Director, Regulatory Affairs – Post-Approval (US Generics)
Company: Teva Pharmaceuticals
Location: Navi Mumbai
Job Type: Full-Time
Experience: Typically 15+ Years (Regulatory Affairs / Pharma Industry)
Qualification: PharmD / M.Pharm (Scientific Discipline)
Salary Range: Not Specified
Job Overview
Teva Pharmaceuticals is hiring a Director, Regulatory Affairs – Post-Approval (US Generics) responsible for leading regulatory strategy and execution for post-approval lifecycle management of U.S. FDA-regulated generic products.
This is a high-impact leadership role involving regulatory strategy, FDA interaction, lifecycle management of ANDA/NDA products, and leading a large regulatory team in a global matrix environment.
Key Responsibilities
1. Regulatory Strategy & Leadership
Define and lead global regulatory strategy for post-approval lifecycle management.
Align regulatory decisions with business and commercial objectives.
Act as the primary regulatory authority for post-approval activities.
2. Post-Approval Lifecycle Management
Oversee regulatory submissions including:
CMC Supplements (CBE-0, CBE-30, PAS)
Annual Reports (active/inactive)
REMS updates and correspondences
Manage lifecycle changes such as:
Site transfers
Formulation changes
Alternate APIs
3. FDA Interaction & Compliance
Act as key liaison with the U.S. Food and Drug Administration
Interpret evolving FDA regulations and guidance.
Ensure compliance with 21 CFR 314.70 and ICH guidelines.
4. Team Leadership & Development
Lead and mentor a high-performing regulatory team.
Drive a culture of accountability, innovation, and continuous learning.
Oversee large and complex regulatory portfolios.
5. Regulatory Operations & Systems
Ensure efficient use of regulatory systems (e.g., Veeva, TrackWise).
Maintain compliance with eCTD submission standards.
Develop SOPs, policies, and training programs.
6. Cross-Functional Collaboration
Partner with internal stakeholders and external partners.
Represent Regulatory Affairs in global governance and strategic planning.
Support business initiatives such as divestments and product launches.
7. Market & Product Lifecycle Activities
Manage product launch notifications and obsolescence.
Oversee updates to regulatory listings like Orange Book.
Required Skills
Regulatory Expertise
Deep knowledge of FDA regulations and post-approval processes.
Strong understanding of ANDA/NDA lifecycle management.
Leadership & Strategy
Proven ability to lead large teams and complex portfolios.
Strong strategic thinking and decision-making skills.
Compliance & Systems
Expertise in regulatory submission systems and eCTD.
Strong grasp of ICH guidelines and global compliance standards.
Communication & Stakeholder Management
Strong negotiation and influencing skills.
Ability to interact with regulatory agencies and executive leadership.
Analytical & Business Acumen
Ability to align regulatory strategy with business goals.
Strong problem-solving and risk assessment capabilities.
Preferred Qualifications
Experience in regulatory intelligence and policy shaping.
Lean Six Sigma or similar process improvement certification.
Experience in multinational and matrixed organizations.
Key Competencies
Regulatory strategy and lifecycle management
FDA interaction and compliance
Leadership and team development
Cross-functional collaboration
Regulatory systems and submissions
Business alignment and strategic thinking
About the Company
Teva Pharmaceuticals is a leading global biopharmaceutical company focused on generics and specialty medicines, with a strong presence in neuroscience and immunology, committed to improving global health outcomes.
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