Executive / Senior Executive – Regulatory Affairs (US Market)
Company: Sun Pharmaceutical Industries Ltd
Business Unit: RBC – Regulatory Affairs
Location: Gurgaon, India
Job Type: Full-Time
Experience Required: 2–4 Years
Job Grade: G12A / G11B
Posted Date: January 9, 2026
Job Overview
Sun Pharma is seeking a highly motivated Executive / Senior Executive – Regulatory Affairs to manage US market regulatory submissions for licensed and clinical biologic products. This role involves providing strategic regulatory guidance, coordinating with global teams, and ensuring compliance with US FDA and international regulations. The ideal candidate will have hands-on experience in CMC regulatory affairs and a strong understanding of regulatory frameworks for biologics.
This position offers an excellent opportunity to engage with global cross-functional teams, influence regulatory strategy, and contribute to the timely approval and lifecycle management of biologic products.
Key Responsibilities
Regulatory Strategy & Compliance
Support and manage Chemistry, Manufacturing, and Controls (CMC) regulatory activities for licensed and clinical biologic products
Provide strategic input to product development and regulatory direction to clinical and commercial teams
Ensure regulatory submissions are timely, accurate, and compliant with US FDA and global health authority requirements
Coordinate with global manufacturing sites to integrate regulatory strategies and communicate updates to senior management
Regulatory Submissions & Documentation
Prepare agency consultation packages, briefing books, and regulatory presentations
Manage filings, including query responses and post-approval changes for global products
Conduct document reviews according to US & emerging market requirements and provide recommendations to the Cross-Functional Team (CFT)
Cross-Functional Collaboration
Engage with internal stakeholders, including clinical, commercial, and quality teams, to ensure alignment of regulatory strategies
Support additional CMC projects and regulatory initiatives as required
Job Requirements
Educational Qualification
Master’s degree in Pharmacy (M.Pharm)
Experience
2–4 years of experience in regulatory affairs, preferably with biologics and US market submissions
Hands-on experience with CMC documentation, regulatory strategy, and filings
Skills & Competencies
Strong knowledge of US FDA regulations and global regulatory guidelines
Excellent communication and coordination skills with global cross-functional teams
Ability to work independently, prioritize tasks, and ensure high-quality deliverables
Proactive approach with attention to detail and problem-solving skills
Gujarat :
Ahmedabad | Ankleshwar | Baroda | Bharuch | Gandhinagar | Gujarat | Halol | Jhagadia | Mehsana | surat | Tarasadi | Vadodara | Vapi |Maharashtra :
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Delhi | India | New Delhi | PAN-India |Assam :
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Pondicherry (Puducherry) |Jharkhand :
Ranchi |Sikkim :
Rangpo |India :
Siliguri |Illinois :
Abbott Park | Bloomingdale | Champaign | Chicago | Deerfield | Glenview | Lake Forest | Lombard | Naperville | Norridge | Park RIdge | Round Lake |Maryland :
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Anchorage | Barrow | Bethel | Juneau | Sitka | Wrangell |Massachusetts :
Andover | Billerica | Boston | Cambridge | Devens | Lexington | Massachusetts | Medford and Somerville | Rockland |Wisconsin :
Appleton | Kenosha | Pleasant Prairie | Portage | Waukesha |United states :
Arizona | Buffalo Grove | Clayton | Downers Grove | fairmont | Georgia | Keene | Michigan | Mt. Pleasant | New Jersy | OH | Piedmont | Salisbury | United States | Whitesboro | Winston-Salem |Georgia :
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Frank Scottile Blvd |Missouri :
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Basel | Zurich |Serbia :
Belgrade | Serbia |Hungary :
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Bulgaria | Vedant |Denmark :
Copenhagen | Denmark |Europe :
Europe | France | Latvia | Lendava | Leuven | Poland | Slovenia | Spain |Finland :
Finland |Istanbul :
Istanbul | Turkey |Norway :
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Wavre |Tipperary :
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Brinny | Ringaskiddy |Carlow :
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Donegal |Meath :
Dunboyne |Dún Laoghaire :
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Galway |County Dublin :
Swords |Republic of China :
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China | Quarry Bay |Liaoning :
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Osaka | Tokyo |Shanghai Sai :
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Netherlands |Remote Australia :
Arkansas | Remote Australia |New South Wales :
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Nedlands |Queensland :
Queensland |Melbourne :
South Yarra |United Kingdom :
England | Harlow | Leeds | London | Maidenhead | Salt Lake City | Stevenage | Stirling | United Kingdom |North Yorkshire :
Harrogate |South Yorkshire :
Sheffield |Oxfordshire :
Witney |Ontario :
Richmond Hill | Renfrew | Australia | North York | Uxbridge | Mississauga |Canada :
Canada |Quebec :
Montreal |Brussels :
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Zaventem |South America :
Argentina | Peru |Brazil :
Brazil | Sao paulo |Attica :
Athens | Koropi |Greece :
Greece |North Island :
Auckland |New Zealand :
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Barcelona |Madrid :
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Manila |Croatia :
Croatia |Zagreb :
Zagreb |Estonia :
Estonia | Tartu |Harju County (Maakond) :
Tallinn |Hà Nội :
Hà Nội | Hanoi |Ho Chi Minh :
Ho Chi Minh City |Italy :
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Oulu |Southwest Finland (Varsinais-Suomi) :
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Kyiv |Lima Region :
Lima |France :
Lyon | Paris |South Africa :
South Africa | Midrand |Nišava District :
Niš |Bohemia :
Prague |Chile :
Santiago |Bosnia and Herzegovina :
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