– Senior Executive – Regulatory Affairs

Industry: Pharmaceuticals Job Location: Chembur East, Mumbai

Experience: 3–4 Years of Relevant Experience

Salary Budget: 6–8 LPA (versatile for suitable candidates)

Gender: Male / Female

Age Limit: Up to 35 Years

Employment Type: Full-Time

Working Days: Monday to Saturday (2nd & 3rd Saturdays Off)

Working Hours: 10:00 AM – 7:00 PM

Job Summary

We are looking for a Senior Executive – Regulatory Affairs with relevant experience in regulatory documentation and dossier submissions for pharmaceutical finished formulations. The candidate should have hands-on experience in manual dossier submissions, eCTD, ACTD, and regulatory requirements for ROW (Rest of World) markets. Candidates must have experience working exclusively with pharmaceutical finished products, such as tablets, capsules, ointments, gels, and injections.

Key Responsibilities

- Prepare, compile, review, and submit regulatory dossiers for pharmaceutical finished formulations.
- Handle manual dossier submissions and electronic Common Technical Document (eCTD) submissions.
- Prepare and manage dossiers in ACTD and CTD formats as applicable.
- Coordinate regulatory submissions and product registration activities for ROW markets.
- Ensure regulatory documents are accurate, complete, and compliant with applicable country-specific requirements.
- Respond to regulatory queries and coordinate the preparation of supporting documentation within specified timelines.
- Review product labels, artworks, and samples to ensure regulatory compliance.
- Coordinate with international agents and internal teams for dossier submissions, registration follow-ups, and regulatory documentation.
- Maintain regulatory records, technical documents, and product registration files.




- Track submission timelines and support timely completion of regulatory activities.

Mandatory Requirements

- 3–4 years of relevant experience in Pharmaceutical Regulatory Affairs.
- Hands-on experience in manual dossier submission.
- Practical knowledge of eCTD and ACTD dossier preparation and submission.
- Experience handling ROW (Rest of World) markets.
- Experience must be exclusively in pharmaceutical finished formulations.
- Candidates with experience in any finished dosage form, including tablets, capsules, ointments, gels, or injections, are eligible.

Educational Qualification

Bachelor's or Master's degree in Pharmacy or a related discipline.

Required Skills

- Regulatory Affairs and Product Registration
- Manual Dossier Submission
- eCTD and ACTD Documentation
- CTD Dossier Preparation
- ROW Market Regulatory Requirements
- Regulatory Documentation and Compliance
- Regulatory Query Management
- Product Artwork and Label Review
- International Agent Coordination
- Documentation Control and Submission Tracking

Candidate Preferences

- Experience: 3–4 years
- Age: Maximum 35 years
- Gender: Male or Female
- Salary: 6–8 LPA; candidates with lower current or expected compensation may also be considered
- Product Category: Finished pharmaceutical formulations only

Important Screening Note: Candidates with experience limited to APIs (Active Pharmaceutical Ingredients) or raw materials should not be considered. Prioritize candidates with direct, hands-on finished-formulation dossier submission experience. ATS Keywords: Senior Executive Regulatory Affairs, Pharmaceutical Regulatory Affairs, Finished Formulations, Manual Dossier Submission, eCTD, ACTD, CTD, ROW Markets, Product Registration, Regulatory Documentation, Pharmaceutical Compliance.

📌 Regulatory Affair - Senior Executive (Chembur)
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📍 Chembur