Job Description:

Position: Asst. Manager/Manager - RA

Location: Daman

Experience: 15 - 20 Years

Industries: Pharma

Responsibilities:
- Lead the Regulatory Affairs function and manage regulatory submissions for domestic and international markets.
- Prepare, review and submit CTD/eCTD dossiers, variations, renewals and regulatory responses.
- Coordinate with R&D;, QA, QC, Production and other departments for regulatory documentation.
- Handle regulatory submissions and approvals for new products, existing products and post-approval changes.
- Review product dossiers, technical documents, specifications, stability data and compliance documents.
- Manage regulatory queries and ensure timely responses to health authorities.
- Monitor changes in regulatory guidelines and requirements and ensure compliance.
- Support regulatory audits and inspections and coordinate responses to observations.
- Maintain regulatory databases, submission trackers and approval records.




- Lead and mentor the RA team and ensure timely completion of regulatory activities.

Required Skills:
- Robust knowledge of Pharma Regulatory Affairs & CTD/eCTD
- Experience in US/EU/ROW or regulated markets
- Expertise in regulatory submissions, variations & renewals
- Strong knowledge of GMP and regulatory guidelines
- Excellent documentation and communication skills
- Strong coordination, leadership and problem-solving abilities
- Experience with ERP/eQMS and regulatory submission systems will be an added advantage

Required Qualification: - B.Pharm/M.Pharm/B.Sc/M.Sc - Chemistry

Salary: - Upto 22.00 LPA

If you are interested for this opening please send updated resume on same mail with following details.

Total No. of Years Experience :-

Current CTC :-

Expected CTC :-

Notice Period :-

📌 Asst. Manager/Manager (Diu)
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