Senior Regulatory Affairs Specialist | New Delhi, India
Job ID: JR_044025 | Category: Regulatory Affairs | Employment Type: Full-Time
About the Role
We are seeking an experienced Senior Regulatory Affairs (RA) Specialist to join our global RA team in New Delhi, India. In this role, you will lead the planning, development, and execution of regulatory strategies for India and neighboring countries, ensuring compliance across product development, labeling, and post-market activities. You will collaborate closely with global and regional RA teams as well as cross-functional departments, including clinical, marketing, and commercial teams, to drive regulatory excellence.
Key Responsibilities
Develop and implement regulatory strategies, timelines, and deliverables in collaboration with cross-functional teams.
Prepare and submit technical files, dossiers, and applications to regulatory authorities and external partners within the region, ensuring accuracy and timeliness.
Maintain regulatory compliance of existing products, including software as a medical device, and provide post-market regulatory support such as Medical Device Reporting.
Review and provide guidance on country-specific advertising, product claims, and direct-to-consumer content.
Conduct regulatory due diligence for new projects, acquisitions, and regional entity initiatives (including eCommerce).
Ensure timely and professional communication with internal stakeholders regarding regulatory plans, updates, and potential impacts.
Monitor external standards, guidelines, and regulatory changes affecting business operations and provide recommended solutions.
Qualifications & Experience
Minimum degree in Life Sciences, Engineering, or related discipline.
At least 6 years of regulatory experience in a regional role handling medical devices or other regulated products in India and comparable markets.
Experience in preparation and submission of regulatory dossiers to India’s Health Authority (CDSCO); experience with submissions in other markets is a plus.
Strong experience reviewing marketing materials and product claims for regulatory compliance.
Excellent interpersonal and communication skills in English.
Proven ability to prioritize workload, work independently, and provide resourceful solutions in a dynamic environment.
Why Join Us
Play a key role in ensuring regulatory compliance for global and regional operations.
Collaborate with an inclusive and innovative team that values diverse perspectives.
Advance your career in a challenging and rewarding environment at the intersection of regulatory strategy, medical device compliance, and business operations.
Work in a culture focused on excellence, professional growth, and innovation.
Location: New Delhi, India
Schedule: Full-Time | Employment Type: Regular
Apply Now to join a global regulatory team and make a significant impact on regulatory compliance, product safety, and market access in India and the region.
Gujarat :
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Frank Scottile Blvd |Missouri :
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England | Harlow | Leeds | London | Maidenhead | Salt Lake City | Stevenage | Stirling | United Kingdom |North Yorkshire :
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Canada |Quebec :
Montreal |Brussels :
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Argentina | Peru |Brazil :
Brazil | Sao paulo |Attica :
Athens | Koropi |Greece :
Greece |North Island :
Auckland |New Zealand :
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Madrid |Cebu Province :
Cebu City |Philippines :
Manila |Croatia :
Croatia |Zagreb :
Zagreb |Estonia :
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Tallinn |Hà Nội :
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Japan | Saitama |Tokyo :
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Oulu |Southwest Finland (Varsinais-Suomi) :
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New Mexico | Ciudad de México |Dubai :
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Kyiv |Lima Region :
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South Africa | Midrand |Nišava District :
Niš |Bohemia :
Prague |Chile :
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