Regulatory Affairs Manager

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
[phone removed]
[email removed]