Hr Services Chandigarh
Regulatory Affairs Manager
10 days ago
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Important information
Contract type:
Permanent
Salary:
₹2,000,000 – ₹2,500,000 / year
Location:
Hyderabad, Telangana, India
Work mode:
Onsite
Published on:
17 October 2026
What they need
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
- Strong knowledge of US regulations, regulatory databases and submission tools
Interested candidates can share their updated CV or contact:
Charu
+91 92563 21852
[email protected]
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