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 Leadership and Development o Supervise and mentor the regulatory affairs team, fostering a culture of collaboration and accountability. o Conduct performance evaluations, provide feedback, and identify training needs for team members.
6. Documentation and Reporting o Maintain accurate records of all regulatory submissions and approvals. o Prepare regular progress reports for senior management, highlighting achievements, challenges, and solutions. Indian FDA guidelines knowledge Understanding & knowledge of standards of various international regulatory bodies SA/ZAZIBONA/EU. Organizational Skills
- Work assignment, time management, working within strict time frames. Ability to solve regulatory queries & compliance matters. Knowledge of dossier types and filing requirements. Prefer professionals with experience in Document (Process, Analytical) review, Dossier preparation and Submission
- for ROW, EU and Other country. Qualifications and Skills Education: Bachelor’s or Master’s degree in Pharmacy, Life Sciences, or a related field. Experience: Minimum of 8 years of experience in regulatory affairs, with at least 2 years in a supervisory role. Knowledge: o Strong understanding of regulatory guidelines and compliance requirements for pharmaceutical manufacturing and export. o Familiarity with technical dossier preparation and submission processes.

Skills : o Excellent organizational and project management skills. o Strong attention to detail and analytical abilities. o Effective communication and interpersonal skills. o Proficiency in regulatory software and tools. Attributes: Proactive, deadline-oriented, and able to work effectively under pressure. Perks & Benefits Competitive salary (based on experience and potential) Comfortable work environment Career growth opportunities in a rapidly expanding organization Company Info: Shop No-23/318, Kondivita lane, Kakad Corner, Marol Pipeline, M.V. Road, Andheri East, Mumbai - 59 Maharashtra

Pay: ₹800,000.00 - ₹1,200,000.00 per year

Work Location: In person

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