Regulatory Affairs Manager

Hr Services Chandigarh; Hyderabad; On-site; INR 2,500,000 - 4,000,000; Full time

Job summary

Hr Services Chandigarh in Hyderabad is seeking a Manager Regulatory Affairs with hands-on US market regulatory experience and 10+ years in the field. The role focuses on US FDA dossiers, CMS sections, and regulatory submissions in a fast-paced pharmaceutical MNC environment.

The candidate should hold an M.Pharm or B.Pharm and be proficient with eCTD submissions, FDA communications, and regulatory databases to ensure timely approvals and compliance.

Qualifications

• Hands-on US Market Regulatory Affairs experience
• 10+ years of relevant experience
• Qualification: M.Pharm or B.Pharm

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

Skills

US Regulatory Affairs

Education

M.Pharm / B.Pharm

Tools

Regulatory databases

FDA submission tools

Job description

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