Regulatory Affairs – Assistant Manager / Manager
Location: Mumbai / Indore
Industry: Pharmaceuticals – Regulatory Affairs Europe Market
Company: Gepach International
Salary: ₹8.4 – 9.6 LPA (negotiable for the right candidate)
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 strong 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
o Manage applications for licenses, permissions, and other regulatory approvals in
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.
Desired Candidate Profile
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
Website: www.gepach.com
Job Type: Full-time
Pay: ₹800,000.00 - ₹1,200,000.00 per year
Work Location: In person
