Job Title: Manager – Regulatory Affairs (US ANDA – Formulations)
Department: Regulatory Affairs
Location: Gurgaon
Reports To: Director
Job Summary
Responsible for end-to-end regulatory activities related to Abbreviated New Drug Applications (ANDAs) for the US market. The role includes dossier preparation, submission, lifecycle management, and direct interaction with the US FDA to ensure timely approvals and compliance.
Key Responsibilities
1. ANDA Dossier Preparation & Submission
- Compile, review, and submit ANDAs in CTD/eCTD format in compliance with US FDA requirements.
- Author and review key modules (Module 1, 2, 3) including administrative, quality, and labeling documents.
- Coordinate bioequivalence (BE) and clinical sections with internal/external stakeholders.
2. Regulatory Strategy (US Market)
- Develop regulatory strategies for ANDA filings (Para I–IV certifications, first-to-file opportunities, etc.).
- Evaluate Reference Listed Drugs (RLD), Orange Book listings, and exclusivity considerations.
- Provide regulatory guidance during product development and pre-submission stages.
3. Lifecycle Management
- Manage post-approval submissions including supplements (PAS, CBE-30, CBE-0), annual reports, and amendments.
- Handle site transfers, formulation changes, and labeling updates.
- Track submission timelines and approval status.
4. US FDA Interaction
- Prepare and submit responses to Complete Response Letters (CRLs), Information Requests (IRs), and deficiency letters.
- Coordinate cross-functional inputs to ensure timely and high-quality responses.
- Support pre-ANDA meetings and other FDA communications.
5. Labeling & Compliance
- Review and update US labeling in line with RLD and FDA requirements.
- Ensure compliance with US regulations (21 CFR Part 314, ICH guidelines).
- Support data integrity and audit readiness.
6. Cross-Functional Collaboration
- Work closely with R&D, Analytical, QA, Manufacturing, and Legal/IP teams.
- Align regulatory strategy with product development, patent landscape, and commercialization plans.
7. Regulatory Intelligence
- Monitor updates from US FDA, guidance documents, and industry trends.
- Assess impact of regulatory changes on ongoing and planned submissions.
Qualifications & Experience
- Education: B.Pharm / M.Pharm / MS in Life Sciences or related field
- Experience:
- 7–12+ years (Manager)
- Proven experience in US ANDA submissions and lifecycle management
- Strong familiarity with US FDA systems (eCTD, ESG)
Key Skills
- In-depth knowledge of US FDA regulations and ANDA process
- Expertise in CTD/eCTD dossier preparation
- Understanding of bioequivalence, dissolution, and QbD concepts
- Strong technical writing and review skills
- Attention to detail and regulatory compliance mindset
- Project management and multi-tasking ability
Preferred Skills
- Experience with Para IV filings and litigation support
- Knowledge of controlled correspondence and pre-ANDA meetings
- Familiarity with tools like Lorenz, Veeva, or similar publishing systems
Key Performance Indicators (KPIs)
- On-time ANDA submissions
- Approval timelines and success rate
- Reduction in FDA queries/deficiencies
- Timely closure of CRLs and IRs
Behavioural Competencies
- Analytical thinking and problem-solving
- Strong ownership and accountability
- Effective stakeholder communication
- Ability to work under tight regulatory timelines
Additional Notes
- Flexibility to work in US time zones when required
- Experience handling multiple ANDAs simultaneously is essential
