Job ID: REQ-10065605
Location: Hyderabad, India
Employment Type: Full-Time | Regular
Division: Development
Business Unit: Development
Functional Area: Research & Development
Novartis is seeking an experienced RA CMC Associate Manager I to support global regulatory activities related to Chemistry, Manufacturing, and Controls (CMC). This role focuses on authoring, preparing, and publishing high-quality regulatory documentation for Health Authority submissions across the product lifecycle. The position also involves coordination, compliance oversight, and active engagement with global RA CMC teams.
Develop and author high-quality global CMC documentation for Health Authority submissions, aligned with regulatory strategies and current guidelines.
Ensure regulatory compliance, technical accuracy, and timely delivery of submission-ready documents according to e-publishing standards.
Identify required technical documents, assess content quality and timelines for global submissions, and negotiate delivery schedules with cross-functional teams.
Coordinate, collect, and manage source documentation essential for CMC submissions to global Health Authorities.
Contribute to regulatory strategy discussions and support the global RA CMC team by identifying critical issues and sharing learnings.
Support department operations including data entry into Regulatory Information Management Systems and maintenance of internal CMC databases.
Report technical complaints, adverse events, and special case scenarios within 24 hours, as applicable.
Manage distribution of marketing samples where required.
Bachelor’s or Master’s degree in Pharmacy, Life Sciences, Chemistry, Biotechnology, or related discipline.
3 to 6 years of experience in Regulatory Affairs CMC within the pharmaceutical or biotechnology industry.
Strong understanding of global CMC regulatory guidelines, regulatory operations, and submission processes.
Proven ability in project management, operations execution, and cross-functional collaboration.
Familiarity with Health Authority interactions and CMC document lifecycle management.
Excellent written communication skills with the ability to produce high-quality regulatory documentation.
At Novartis, our purpose is to reimagine medicine to improve and extend lives. Our people drive our vision to be the world’s most trusted medicines company. By joining our team, you will contribute to impactful work while building a rewarding career.
To learn more about our culture and people:
Visit: Novartis People & Culture
Novartis offers comprehensive benefits that support professional growth, personal well-being, and long-term career development.
Details available in the Novartis Life Handbook.
Novartis is dedicated to fostering an inclusive workplace and building diverse teams representative of the patients and communities we serve.
If you require any accommodation due to a disability or medical condition during the recruitment process or to perform essential job functions, contact:
diversityandincl.india@novartis.com
Include the job requisition number in your message.
If this role does not align with your current goals but you wish to explore future opportunities at Novartis, join the Novartis Talent Network.
Gujarat :
Ahmedabad | Ankleshwar | Baroda | Bharuch | Gandhinagar | Gujarat | Halol | Jhagadia | Mehsana | surat | Tarasadi | Vadodara | Vapi |Maharashtra :
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Baddi | Solan |Rajasthan :
Banasthali | Bhiwadi | Jaipur | Pilani | Udaipur |Karnataka :
Bangalore | Belgaum | Bengaluru | B.G Nagara | Bommasandra | Colorado | Czech Republic | Karnataka | Mangaluru | Mysore | Udupi |Punjab :
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Bilaspur | Eot Municipality | Raipur |Uttarakhand :
Dehradun | Halifax | Nainital | Rishikesh | Roorkee |Delhi :
Delhi | India | New Delhi | PAN-India |Assam :
Dibrugarh | Diburghar | Guwahati |West Bengal :
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Hajipur | Patna |Kerala :
Kannur | Kochi | Malappuram | Thiruvananthapuram | Trivandrum |Pondicherry (Puducherry) :
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 :
Atlanta | Augusta | Rome |Maine :
Bangor | Brewer |New Jersey :
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Dickinson |Minnesota :
Duluth | Eden Prairie | Fridley | Hibbing | Maple Grove | Minneapolis and St. Paul, Minnesota. | Minnetonka | St.Paul |Kentucky :
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Frank Scottile Blvd |Missouri :
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Germany | GErmany |Lower Saxony :
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Ingelheim am Rhein | Mainz |Schleswig Holstein :
Kiel |Berlin :
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Budapest |BULGARIA :
Bulgaria | Vedant |Denmark :
Copenhagen | Denmark |Europe :
Europe | France | Latvia | Lendava | Leuven | Poland | Slovenia | Spain |Finland :
Finland |Istanbul :
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Swords |Republic of China :
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China | Quarry Bay |Liaoning :
Dalian |Zhejiang :
Hangzhou |Tokiyo :
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Wuhan |Capital of Netherland :
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Netherlands |Remote Australia :
Arkansas | Remote Australia |New South Wales :
Ballina | Sydney |Republic of Western Australia :
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 :
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Canada |Quebec :
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Zaventem |South America :
Peru | Argentina |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 :
Tartu | Estonia |Harju County (Maakond) :
Tallinn |Hà Nội :
Hanoi | Hà Nội |Ho Chi Minh :
Ho Chi Minh City |Italy :
Italy |Lombardy :
Rho |Jakarta :
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Surabaya |Japan :
Saitama | Japan |Tokyo :
Otemachi |North Ostrobothnia :
Oulu |Southwest Finland (Varsinais-Suomi) :
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Remote Korea |Republic of Korea :
Seoul |Kazakhstan :
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Bangkok |Israel :
Netanya | Kfar Saba | Yavne | Tel Aviv | Be'Er Sheva |Remote :
McFarland | Green Way | Springville | Nairobi | Remote - South America (Latin Americal) | French | Melbourne | Remote, USA | Zaragoza | Medan | Lenexa | Switzerland | Remote - Africa | Bountiful | Remote | Castlebar | Leinster | Bishop | Lousiana | Thailand | Regulatory Labeling Manager (NA and LATAM Only) | Hungary | Texas | Riga | Faridabad | Remote - Europe | Belgium | Tulsa | Minnesota | Ireland | Remote - Middle East | Hammond | Manipal | Slovakia | Victoria | Blue Bell | Xzagreb |Republic of Colombia :
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Buenos Aires |Republic of Egypt :
Cairo |Mexico :
Ciudad de México | New Mexico |Dubai :
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Rabigh | Jeddah | King Abdullah Economic City | Khulais | Najran | Riyadh |Kuala Lumpur :
Kuala Lumpur |Kyiv Oblast :
Kyiv |Lima Region :
Lima |France :
Paris | Lyon |South Africa :
Midrand | South Africa |Nišava District :
Niš |Bohemia :
Prague |Chile :
Santiago |Bosnia and Herzegovina :
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