Job
Description
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 New 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
