Deputy Manager, Regulatory Affairs
Amneal Pharmaceuticals is seeking a Deputy Manager for Regulatory Affairs to lead dossier compilation and regulatory strategy for complex injectable products. The role involves managing submissions for the US, EU, and Canada markets while ensuring compliance with FDA and ICH guidelines. The candidate will coordinate cross-functional teams, handle deficiency letters, and mentor junior staff. This is a senior-level position requiring extensive experience in regulatory filings and submission traceability.
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Experience
8-10 years
Function
Research
Work mode
Onsite, India
Company
Tier 2
What you will work on
Amneal Pharmaceuticals is seeking a Deputy Manager for Regulatory Affairs to lead dossier compilation and regulatory strategy for complex injectable products. The role involves managing submissions for the US, EU, and Canada markets while ensuring compliance with FDA and ICH guidelines. The candidate will coordinate cross-functional teams, handle deficiency letters, and mentor junior staff. This is a senior-level position requiring extensive experience in regulatory filings and submission traceability.
TAL's take
Solid, well-defined role in a stable pharmaceutical firm with clear expectations regarding regulatory compliance and project leadership.
The JD is highly specific regarding the types of filings (ANDA, 505(b)(2)), the product domain (injectables), and the regulatory bodies involved (FDA, EMA).
Must haves
- 8+ years of regulatory affairs experience
- Experience in dossier compilation for US/EU/Canada
- Hands-on leadership for 505(b)(2) application strategy
- Knowledge of FDA guidance and ICH guidelines
- B. Pharm degree
Tools and skills
About the company
Established pharmaceutical company with a solid market presence, fitting the criteria for an established product-focused company.