Regulatory Affairs - Assistant Manager / Manager
Location: Mumbai / Indore
Industry: Pharmaceuticals - Regulatory Affairs Europe Market
Company: Gepach International
Employment Type: Full-time, Permanent
About the Company
Gepach International is a 31-year-young pharmaceutical company engaged in the manufacturing,
export, and marketing of branded generics. We have a robust presence in international markets
including Russia, CIS, FWA Countries and SEA, U.K, Europe, Australia and South Africa. Our
product range includes Oral and Injectable antibiotics, OTC products, Nutritional supplements,
General Tablets Effervescent, Coated and Capsules Lozenges.
We are headquartered in Andheri East, Mumbai, and are focused on expanding to 50 countries
and tripling our revenue in the next 3 years.
Job description
Key Responsibilities
1. Dossier Preparation and Review
o Oversee the preparation of technical product dossiers, ensuring accuracy,
completeness, and compliance with regulatory requirements.
o Review dossiers prepared by team members to ensure they meet national and




international standards.
o Provide guidance and technical expertise to the team during dossier preparation.
2. Regulatory Submissions and Approvals
the country of manufacture and export destinations.
o Coordinate with relevant regulatory authorities to resolve queries and ensure
timely approvals.
3. Task Management and Timeliness
o Ensure timely completion of departmental tasks, adhering to internal and external
deadlines.
o Prioritize assignments and allocate resources effectively to maintain productivity.
4. Compliance Assurance
o Ensure that all regulatory guidelines are strictly adhered to during product
manufacturing and export processes.
o Stay updated on changes in regulatory requirements and communicate updates to
the team.
o Coordinating the inspection of the organization facilities and contract facilities
and developing procedures to ensure regulatory procedures to ensure regulatory
compliance
5. Team L

📌 Regulatory Affairs Manager (Indore)
🏢 Gepach International
📍 Indore