We are hiring for the position of Manager Regulatory Affairs -US market experience Must
Qualification: M.Pharm / B.Pharm
Experience: 10yrs+ of relevant experience
Location: Hyderabad
Industry: Pharmaceutical MNC
Mandatory: Hands-on US Market Regulatory Affairs experience
Key Responsibilities
- Compilation of ANDA dossiers in eCTD format, mainly CMS sections
- Preparation of responses to US FDA queries
- Preparation and submission of Annual Reports
- Knowledge of CBE-0, CBE-30 & PAS submissions
- Preparation of cover letters, FDA forms and regulatory strategies for timely submissions
- Robust knowledge of US regulations, regulatory databases and submission tools
Interested candidates can share their updated CV or contact:
Charu
+91 92563 21852
[email protected]
📌 Regulatory Affairs Manager (Hyderabad)
🏢 Hr Services Chandigarh
📍 Hyderabad