Trident Lifeline Limited is looking for an experienced Regulatory Affairs professional to independently manage and lead regulatory activities for pharmaceutical formulations, particularly Tablets and Capsules, across Domestic and International Markets.

The candidate will be responsible for product registration, dossier preparation, regulatory queries, product permissions, variations, product samples, regulatory documentation, plant inspections, CAPA coordination, artwork review, and team management.

The candidate should have strong hands-on knowledge of international regulatory requirements and should be capable of independently handling regulatory activities with minimum supervision.

Key Responsibilities

1. Product Registration & Dossier Management

- Handle end-to-end product registration activities for Tablets and Capsules.
- Prepare, compile, review and submit regulatory dossiers as per country-specific requirements.
- Manage product registration in various international markets, including but not limited to:
- Myanmar, Kuwait, Philippines, Congo, Tanzania, Uganda, Kenya, Yemen, Sri Lanka, Iraq, Saudi Arabia, Jordan, Ghana
- Understand and evaluate country-specific regulatory requirements and ensure timely submission of required documents.
- Maintain product registration trackers and monitor submission, approval and renewal timelines.

2. Regulatory Query Management

- Handle and coordinate responses to regulatory queries, deficiencies and clarification requests received from respective authorities, customers or agents.
- Coordinate with QA, QC, Production, R&D;, IPQA and other departments to collect required technical information and documents.
- Ensure timely and accurate submission of responses within regulatory timelines.
- Maintain proper records of queries and responses.

3. Product Samples & Registration Requirements

- Coordinate arrangement and availability of product samples required for registration and regulatory submissions.
- Coordinate with Production, QA, QC, Warehouse and other concerned departments for timely sample preparation.
- Ensure samples and supporting documents are made available as per country-specific requirements.

4. Product Permission & Registration Status

- Follow up regularly on Product Permission, Registration Approval, Renewal and Variation status.
- Coordinate with international customers, agents,



consultants and regulatory representatives.
- Maintain an updated status report of all products and countries.
- Escalate delays or regulatory issues to management with appropriate action plans.

5. Site Variation & Post-Approval Activities

- Handle site variations, manufacturing site changes and other post-approval regulatory activities.
- Coordinate documentation and submission requirements for site variations in applicable markets, including Ghana and other assigned countries.
- Manage variations, amendments, renewals and other post-registration activities within defined timelines.

6. NOC & Regulatory Applications

- Prepare and coordinate NOC applications and other regulatory permissions through applicable regulatory portals/systems.
- Ensure proper documentation and timely submission of NOC and related applications.
- Track application status and coordinate for closure/approval.

7. Plant Inspection & CAPA Coordination

- Coordinate with TNS and relevant internal teams regarding product registration, regulatory requirements and plant inspections.
- Support preparation for regulatory/customer inspections.
- Coordinate collection of required documents and evidence for inspection requirements.
- Coordinate with QA, Production and concerned departments for CAPA preparation and closure arising from regulatory/plant inspections.
- Follow up on CAPA commitments and ensure timely submission/closure.

8. Artwork & Commercial Documentation

- Review and coordinate product artwork, labels, packing materials and regulatory information for respective products.
- Check regulatory compliance of product artwork against approved registration documents and country-specific requirements.
- Review commercial annexures and supporting regulatory documents for respective products.
- Coordinate corrections with concerned departments before final approval.

9. Domestic Regulatory Affairs

- Handle applicable Domestic Regulatory Affairs activities for assigned products.
- Support product permissions, registrations, renewals,



variations and other regulatory requirements.
- Monitor changes in applicable Indian regulatory requirements and communicate relevant requirements internally.

10. International Market Coordination

- Act as a key regulatory point of contact for international markets.
- Communicate with overseas customers, agents, consultants and regulatory authorities as applicable.
- Understand country-specific requirements and provide regulatory inputs to Business Development and Management.
- Support regulatory strategy for new products and new markets.

11. Team Management & Leadership

- Lead and manage the Regulatory Affairs team.
- Allocate responsibilities and monitor submission and registration timelines.
- Review work prepared by team members before submission.
- Guide junior and mid-level RA team members on dossier preparation, regulatory queries and documentation.
- Conduct regular follow-ups with team members to ensure timely completion of regulatory activities.
- Develop team capability and ensure proper regulatory documentation practices.

Required Experience & Skills :- The ideal candidate should have:
- 7–12 years of relevant experience in Pharmaceutical Regulatory Affairs.
- Strong hands-on experience in Tablets and Capsules.
- Experience in Domestic and International Regulatory Affairs.
- Strong experience in dossier preparation and product registration.
- Experience handling regulatory queries and deficiencies.
- Experience in registration, renewals, variations, site variations and post-approval activities.
- Experience in multiple international markets, particularly African, Middle Eastern and Asian markets.
- Robust understanding of pharmaceutical regulatory documentation and submission requirements.
- Experience in coordinating plant inspections and CAPA.
- Experience in artwork and regulatory/commercial document review.
- Ability to coordinate product samples and registration requirements.
- Strong communication and stakeholder-management skills.
- Strong team-handling and leadership experience.
- Ability to independently manage multiple countries and products simultaneously.

Pay: ₹40,000.00 - ₹80,000.00 per month

Benefits

- Cell phone reimbursement
- Food provided
- Leave encashment
- Life insurance
- Paid sick time
- Provident Fund

Work Location: In person

📌 Regulatory Affairs Manager (Surat)
🏢 Trident Lifeline
📍 Surat