Executive - Regulatory Affairs- Delhi

Domnic Lewis has been mandated to hire for Executive - Regulatory Affairs- Delhi

Position Title: Executive – Regulatory Affairs

Grade: C

Reports to: Lead/Manager – Regulatory Affairs

Position Purpose

- Monitor and report the status of all product licenses in a timely and accurate manner

- Support the implementation of submission plans for new product registrations and ongoing product maintenance (e.g., amendments, renewals, updates)

- Manage SUGAM portal submissions as assigned

- Prepare and coordinate responses to queries from health authorities

- Maintain regulatory trackers, documentation, and archival systems

- Plan and execute timely submission of various regulatory applications, including but not limited to: test license applications, clinical trial notifications (e.g., IB amendments, site changes, EC approvals), and responses to HAQs

- Provide regulatory documentation support for tender processes

Key Internal Stakeholders

- Marketing, Sales, Logistics

- Medical Affairs, Legal Affairs, Intellectual Property

- Clinical Operations, Product Teams, Brand Teams

- International Regulatory Affairs, QA, Manufacturing Sites, Regional Offices

Key External Stakeholders

- Local Health Authorities

- Relevant Government Agencies

Minimum Requirements

- Qualification: M.Pharm / B.Pharm / M.Sc

- Experience: 2–3 years in Indian Regulatory Affairs

- Knowledge: Familiarity with dossier compilation and current Indian regulatory guidelines

Key Result Areas and Outputs

1. Regulatory Compliance and Ethics

- Ensure alignment with company values, applicable legislation, and industry codes of conduct

- Adhere to corporate governance, audit requirements, and ethical practices





- Maintain confidentiality of sensitive company and product information

- Report any potential violations of codes or conduct standards

2. Licensing and Documentation

- Monitor and track the status of all product licenses

- Coordinate updates or changes in licenses, ensuring timely communication and documentation

- Maintain organized and updated records and trackers

3. Regulatory Strategy and Recent Product Launches

- Understand product strategy, dossier content, and regulatory intelligence

- Contribute to the planning and execution of regulatory strategies for new launches

- Ensure timely submissions and approvals for rapid market entry

4. Cross-functional Collaboration

- Work closely with cross-functional teams (e.g., QA, Supply Chain, Clinical Ops, Medical, Market Access)

- Coordinate with international and regional regulatory colleagues

- Take ownership of assigned projects with minimal supervision

- Support onboarding and mentoring of junior team members or contract associates

5. Life Cycle Management

- Ensure timely compliance submissions for both commercial and clinical trial products

- Support audits and manage deviations or CAPAs as required

- Assist in import registration/renewal and production transfers

- Review and support packaging/artwork updates and local licensing

6. Clinical Trial Support

- Manage submissions, responses, and approvals for clinical trials, including Phase IV and PMS studies

- Ensure compliance throughout the study lifecycle, from initiation to closure

- Prepare for Subject Expert Committee (SEC) reviews and meetings

7. Competitive Intelligence

- Monitor global pipelines and regulatory trends of competitor companies

- Assess potential impact on internal development plans and provide strategic input as required

📌 Executive - Regulatory Affairs (New Delhi)
🏢 AstraZeneca
📍 New Delhi