Job Description Sr. Executive, Regulatory Affairs

Designation: Sr. Executive Regulatory Affairs
Department: Regulatory Affairs
Qualification: B. Pharm / M. Pharm
Experience: Minimum 3 Years
Industry: Pharmaceutical

Job Summary

We are looking for a detail-oriented and experienced Sr. Executive – Regulatory Affairs to manage regulatory documentation, dossier compilation, and submission activities for pharmaceutical products across international markets.

Key Responsibilities

- Compile and review regulatory dossiers in ACTD, CTD, and country-specific formats.
- Prepare, compile, and maintain regulatory documentation as per applicable country-specific requirements.
- Review technical and regulatory documents, including:
- MFR (Master Formula Record)
- PVP/PVR
- Stability Reports
- Process/Product Validation documents
- DMF (Drug Master File)
- Other CMC and supporting regulatory documents

- Coordinate closely with Manufacturing, Quality Assurance, Quality Control, R&D;, and other relevant departments/sites to ensure timely availability and compliance of regulatory documents.
- Review documents for accuracy, completeness, consistency, and compliance with regulatory requirements.
- Handle and respond to regulatory queries and deficiency letters independently, in coordination with relevant internal teams.
- Support preparation and submission of responses to regulatory authorities.
- Maintain and update regulatory databases, trackers, and document management systems.




- Ensure proper archival and maintenance of regulatory submissions and supporting documents.
- Track submission status, regulatory queries, commitments, and approvals.
- Stay updated on changes in regulatory guidelines and country-specific requirements.
- Support regulatory activities for international markets, including Africa, ASEAN, CIS, and LATAM.

Required Skills & Competencies

- Solid knowledge of pharmaceutical regulatory affairs and dossier compilation.
- Hands-on experience with ACTD/CTD and country-specific dossier formats.
- Good understanding of CMC documentation and regulatory requirements.
- Strong document review and analytical skills.
- Ability to independently handle regulatory queries and prepare responses.
- Good coordination and communication skills.
- Strong attention to detail and ability to manage multiple regulatory activities simultaneously.
- Good working knowledge of MS Office, regulatory databases, and document management systems.

Preferred Candidate Profile

- B. Pharm / M. Pharm with minimum 3 years of relevant experience in Regulatory Affairs.
- Candidates with international regulatory exposure will be preferred.
- Experience handling regulatory submissions for Africa, ASEAN, CIS, and/or LATAM markets will be an added advantage.
- Immediate joiners will be preferred.
- Candidates from the pharmaceutical manufacturing/marketing industry with relevant regulatory experience are preferred.

📌 Senior Regulatory Executive/Sr. RA Executive (Ahmedabad)
🏢 ALVIO PHARMACEUTICALS
📍 Ahmedabad