Manager – Regulatory Affairs (CRLB) – Mumbai, India
Location: Mumbai, India
Category: Regulatory Affairs
Role Overview
The Manager – Regulatory Affairs serves as a senior specialist and individual contributor with in-depth expertise in global regulatory frameworks. The role involves leading complex regulatory activities, directing submissions, collaborating with regulatory authorities, and ensuring full compliance across the product lifecycle. This position requires the ability to manage advanced, specialized projects and develop innovative regulatory solutions beyond traditional approaches.
Key Responsibilities
Regulatory Strategy & Submission Management
Lead the preparation and review of regulatory submissions, including product registration dossiers, supplements, amendments, progress reports, and periodic experience reports.
Serve as a primary regulatory expert, ensuring submissions meet global regulatory standards and internal compliance requirements.
Engage with regulatory agencies to expedite approvals and resolve queries promptly.
Act as a regulatory liaison throughout the product lifecycle, from development to commercialization.
Cross-Functional Collaboration
Participate in product planning, regulatory strategy development, risk management programs, and Chemistry Manufacturing Control (CMC) activities.
Provide guidance to development, manufacturing, and marketing teams on regulatory pathways, labeling, line extensions, and technical documentation.
Offer regulatory interpretation to support decision-making on manufacturing changes or product updates.
Regulatory Compliance
Ensure timely approval for new drugs, biologics, and medical devices, as well as maintenance of approvals for marketed products.
Represent Regulatory Affairs during internal reviews, research discussions, and interactions with external authorities.
Maintain comprehensive understanding of regulatory requirements across global markets and ensure organizational adherence.
Qualifications
Education
Associate degree or higher (Life Sciences, Pharmacy, Biotechnology, or related fields preferred).
Advanced certifications or specialized regulatory training will be considered an advantage.
Experience Required
Minimum 7 years of experience in Regulatory Affairs within the pharmaceutical, biotechnology, or medical device industry.
Proven expertise in regulatory submissions, agency interactions, and lifecycle management.
Strong understanding of global regulatory frameworks and CMC processes.
Why This Role Is Critical
This position plays a crucial role in accelerating regulatory approvals, ensuring ongoing compliance, and supporting the successful launch and maintenance of pharmaceutical or biologic products. The role contributes directly to organizational growth, product safety, and market access.
Gujarat :
Ahmedabad | Ankleshwar | Baroda | Bharuch | Gandhinagar | Gujarat | Halol | Jhagadia | Mehsana | Tarasadi | Vadodara | Vapi |Maharashtra :
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Bangalore | Belgaum | Bengaluru | B.G Nagara | Bommasandra | Colorado | Czech Republic | Karnataka | Mangaluru | Mysore | Udupi |Punjab :
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Siliguri |Illinois :
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Frank Scottile Blvd |Missouri :
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Saarbrucken |Switzerland :
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Copenhagen | Denmark |Europe :
Europe | France | Latvia | Lendava | Leuven | Poland | Slovenia | Spain |Finland :
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Istanbul | Turkey |Norway :
Norway | NOrway |Romania :
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Carlow |Republic of Ireland :
Cork | Dublin | Limerick | Waterford |Ulster :
Donegal |Meath :
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Dún Laoghaire |Galway :
Galway |County Dublin :
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China | Quarry Bay |Liaoning :
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Hangzhou |Tokiyo :
Osaka | Tokyo |Shanghai Sai :
Shanghai Shi |Hubei :
Wuhan |Capital of Netherland :
Amsterdam |North Brabant :
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Netherlands |Remote Australia :
Arkansas | Remote Australia |New South Wales :
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Queensland |Melbourne :
South Yarra |United Kingdom :
England | Harlow | Leeds | London | Maidenhead | Salt Lake City | Stevenage | Stirling | United Kingdom |North Yorkshire :
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Witney |Ontario :
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Canada |Quebec :
Montreal |Brussels :
Brussels |Antwerp :
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Zaventem |South America :
Argentina | Peru |Brazil :
Brazil | Sao paulo |Attica :
Koropi | Athens |Greece :
Greece |North Island :
Auckland |New Zealand :
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Austria |Vienna :
Vienna |Catalonia :
Barcelona |Madrid :
Madrid |Cebu Province :
Cebu City |Philippines :
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 :
Italy |Lombardy :
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Jakarta |East Java :
Surabaya |Japan :
Japan | Saitama |Tokyo :
Otemachi |North Ostrobothnia :
Oulu |Southwest Finland (Varsinais-Suomi) :
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Remote Korea |Republic of Korea :
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Brentwood |Bucharest :
Bucharest |Buenos Aires :
Buenos Aires |Republic of Egypt :
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New Mexico | Ciudad de México |Dubai :
Dubai |Makkah :
Najran | Rabigh | Riyadh | Khulais | Jeddah | King Abdullah Economic City |Kuala Lumpur :
Kuala Lumpur |Kyiv Oblast :
Kyiv |Lima Region :
Lima |France :
Paris | Lyon |South Africa :
South Africa | Midrand |Nišava District :
Niš |Bohemia :
Prague |Chile :
Santiago |Bosnia and Herzegovina :
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