We are hiring:
Function: Regulatory Affairs- US
M.Pharm with 10 -14 years of relevant experience
Job Location: Vadodara
Brief Job Description
1. Regulatory activities for US, EU, and Canada markets.
2. Handle Complex Generic Products and Drug-Device Combination Products
Manage New ANDA submissions and agency query responses
3. Develop regulatory strategies for complex generic product development
4. Support product development teams from a regulatory perspective
Prepare and review eCTD submissions 5.
Strong understanding of FDA, EMA, and Health Canada requirements • Experience in regulatory strategy development • Excellent communication and stakeholder management skills
Please share your resume at: Rosemary.varghese@sunpharma.com

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