Executive, Regulatory Affairs
Amneal Pharmaceuticals is hiring a Regulatory Affairs Executive to manage ANDA submissions and post-approval procedures. The role involves drafting and reviewing regulatory documentation in compliance with ICH and USFDA guidelines for various dosage forms. Candidates will coordinate with cross-functional teams to ensure timely regulatory filings and maintain compliance. This is a specialized role requiring strong technical documentation skills in a pharmaceutical environment.
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Experience
5-8 years
Function
Research
Work mode
Onsite, India
Company
Tier 2
What you will work on
Amneal Pharmaceuticals is hiring a Regulatory Affairs Executive to manage ANDA submissions and post-approval procedures. The role involves drafting and reviewing regulatory documentation in compliance with ICH and USFDA guidelines for various dosage forms. Candidates will coordinate with cross-functional teams to ensure timely regulatory filings and maintain compliance. This is a specialized role requiring strong technical documentation skills in a pharmaceutical environment.
TAL's take
Solid industry-specific role at an established pharmaceutical firm, though the scope is fairly standard for a regulatory position.
The responsibilities are very specific to regulatory affairs and ANDA submission processes, providing a clear picture of the role.
Must haves
- 5+ years of experience in regulatory affairs
- Knowledge of ANDA submission activities
- Understanding of ICH and USFDA guidelines
- Experience with post-approval procedures
- Proficiency in CTD modules drafting
Tools and skills
About the company
Established pharmaceutical company with a solid market presence, falling under tier 2 status.