Position: Senior Executive
Location: Navi Mumbai (Mahape)
Department: Regulatory Affairs
Reporting To: Regulatory Affairs Manager
About Celogen
Celogen Pharma Pvt. Ltd. is a growing pharmaceutical manufacturing company engaged in the development and manufacturing of high-quality pharmaceutical formulations for domestic and international markets. The company operates advanced manufacturing facilities, including a dedicated hormone manufacturing unit in Gozaria, Gujarat, and additional manufacturing units in Ponda, Goa, and Somnath Road, Daman. With a strong focus on quality, compliance, hygiene, and operational excellence, Celogen Pharma is committed to delivering safe, effective, and affordable healthcare solutions while maintaining high standards across all its operations.
Position Summary
The Senior Executive - Regulatory Affairs will be responsible for preparing, reviewing, submitting, and maintaining technology transfer documents, regulatory dossiers and product registrations for pharmaceutical products across international markets throughout their product lifecycle (including handling of NODs). The role requires sound knowledge of regulatory requirements for Rest of World (ROW) markets, EU markets, CTD dossier preparation, and coordination with cross-functional teams to ensure timely regulatory submissions and compliance.
Key Responsibilities
1. Regulatory Submissions & Documentation
- Prepare, compile, review, and submit regulatory dossiers for product registrations, renewals, variations, NODs, and tender submissions.
- Ensure all product regulatory submission requirements are complete, accurate, and submitted within stipulated timelines.
- Maintain product registration documents and database, submission trackers, regulatory databases, and product license records.
- Maintain regulatory archives and ensure effective document control.
2. Regulatory Compliance & Strategy
- Prepare, review and share technology transfer documents with sites for new product developments and/or site transfers
- Monitor updates to international regulatory guidelines, legislation, and market requirements applicable to EU and ROW markets.
- Interpret regulatory changes and communicate their impact to relevant stakeholders.
- Provide regulatory support to cross-functional teams, including R&D, Quality Assurance, Manufacturing, and Business Development.
- Support regulatory strategies for new product registrations, lifecycle management, renewals, and post-approval variations.
- Ensure compliance with applicable regulatory requirements and internal quality systems.
3. Regulatory Coordination & Communication
- Coordinate with internal departments, manufacturing sites, customers, and regulatory authorities regarding submission requirements.
- Prepare responses to regulatory queries, deficiency letters, and health authority communications.
- Support customer registrations and international tender documentation.
- Participate in internal audits, customer audits, and regulatory inspections.
- Assist in regulatory due diligence activities and maintain effective communication with external stakeholders.
- Assist in preparation of Standard Operating Procedures of Regulatory Affairs Department.
Education
- M.Pharm from a recognized university.
Experience
- 4-5 years of experience in Regulatory Affairs within the pharmaceutical industry.
- Hands-on experience in CTD dossier preparation and submissions for ROW markets.
- Experience in product registrations, renewals, variations, and tender documentation.
- Exposure to regulated market submissions (MHRA) will be an added advantage.
Skills & Competencies
- Good knowledge of international regulatory requirements, particularly EU and ROW markets.
- Working knowledge of ICH guidelines and CTD/eCTD documentation.
- Excellent documentation and technical writing skills.
- Strong analytical, organizational, and time management skills.
- Ability to manage multiple submissions while meeting regulatory timelines.
- Good communication and stakeholder coordination skills.
- Proficiency in Microsoft Office (Excel, Word, PowerPoint, Outlook).
Pay: ₹420,000.00 - ₹528,000.00 per year
Application Question(s):
- Will you be able to reliably commute to Mahape, Navi Mumbai, Maharashtra for this job?
Education:
Work Location: In person
