About the Role

NKG is looking for an experienced Senior Regulatory Affairs Executive with 3+ years of relevant experience in Regulatory Affairs and regulatory consulting, preferably with exposure to Drugs/Pharmaceuticals, Diagnostics and Medical Devices.

The candidate will be responsible for independently managing regulatory projects, client requirements, regulatory submissions, approvals and compliance activities.

Key Responsibilities

- Manage end-to-end regulatory projects from initial assessment through submission, approval and post-approval activities.
- Handle regulatory requirements for Drugs/Pharmaceuticals, Diagnostics and Medical Devices.
- Review products and determine applicable regulatory pathways, classification and documentation requirements.
- Prepare, review and compile regulatory dossiers, applications and technical documentation.
- Handle product registrations, licenses, approvals, renewals, amendments, variations and post-approval changes.
- Prepare and manage responses to regulatory queries, deficiencies and clarification letters.
- Coordinate with CDSCO, State Drug Authorities and other applicable regulatory authorities.
- Coordinate with clients, manufacturers, importers and other stakeholders for regulatory submissions and documentation.
- Provide regulatory guidance and compliance support to clients based on applicable requirements.




- Monitor regulatory updates and assess their impact on client products and ongoing projects.
- Maintain regulatory trackers, submission records, approvals and project documentation.
- Independently manage multiple projects and ensure quality and timely delivery.
- Review regulatory work prepared by junior team members and provide guidance where required.
- Participate in client discussions and support resolution of complex regulatory matters.

Required Skills & Experience

- 3+ years of relevant experience in Regulatory Affairs, preferably in a regulatory consulting environment.
- Strong hands-on experience in Drugs/Pharmaceuticals.
- Experience in Diagnostics and/or Medical Devices will be an advantage.
- Good understanding of CDSCO, State Drug Authorities and applicable Indian regulatory requirements.
- Experience in regulatory submissions, dossier preparation, product registration, licensing, renewals and amendments.
- Robust client handling and project management skills.
- Excellent analytical, documentation, communication and problem-solving skills.
- Ability to independently manage regulatory projects and timelines.

Qualification

Bachelor's/Master's degree in Pharmacy, Life Sciences, Biotechnology, Microbiology or a relevant discipline.

Apply at [email protected]

📌 Senior Regulatory Affairs Executive (Delhi)
🏢 NKG Advisory Business u0026 Consulting Services
📍 Delhi