Regulatory Associate – EU Market (CMC Module 3)
Updated: Yesterday
Location: Pune, Maharashtra, India
Job ID: 25105261
Employment Type: Full-Time
About Syneos Health
Syneos Health® is a leading global biopharmaceutical solutions organization focused on accelerating customer success across the clinical development, medical affairs, and commercial continuum. With a presence in over 110 countries and a workforce of more than 29,000 professionals, Syneos Health delivers integrated, patient-centric solutions that address evolving regulatory and market needs worldwide.
Role Overview
The Regulatory Associate – EU Market (CMC Module 3) supports regulatory submission activities for small molecule products, with a primary focus on Chemistry, Manufacturing, and Controls (CMC) documentation. This role contributes to the preparation, review, and lifecycle management of regulatory dossiers for the European Union market, while also supporting submissions across additional international regions.
Key Responsibilities
Support the preparation of product development and regulatory documentation, including gap analyses and development plans
Assist in the compilation and maintenance of CMC Module 3 documentation for small molecule products
Contribute to regulatory submissions including INDs, NDAs, MAAs, DMFs, variations, renewals, and marketing authorisation transfers (MATs)
Support lifecycle management activities in compliance with current EU, ICH, and regional regulatory guidelines
Conduct regulatory intelligence and research to identify applicable precedents and regulatory requirements
Assist in the preparation of orphan drug designation documentation, where applicable
Perform quality checks to ensure accuracy, consistency, and compliance of submission documents
Support submission publishing and coordination activities as required
Gather, analyze, and compile regulatory data and supporting documentation
Prepare routine regulatory correspondence and internal reports
Collaborate with cross-functional teams including CMC, quality, clinical, and project management
Required Experience
6 months to 2 years of relevant experience in regulatory affairs or regulatory operations
Internship experience in regulatory affairs is acceptable and preferred
Hands-on exposure to CMC documentation (Module 3) for small molecule products
Experience supporting EU regulatory submissions is strongly preferred
Exposure to GCC and APAC markets is an added advantage
Educational Qualifications
Bachelor’s degree in Pharmacy, Life Sciences, Chemistry, Biotechnology, or a related scientific discipline
Postgraduate qualification in Regulatory Affairs is an advantage
Required Skills and Competencies
Strong understanding of regulatory submission processes and lifecycle management
Working knowledge of EU regulatory frameworks and ICH guidelines
High attention to detail with strong analytical and documentation skills
Excellent written and verbal communication skills in English
Proficiency in Microsoft Office applications (Word, Excel, PowerPoint)
Ability to manage multiple tasks and work across concurrent projects
Strong organizational, time management, and collaboration skills
Ability to work independently while contributing effectively within a team environment
Why Join Syneos Health
Exposure to global regulatory projects across multiple international markets
Structured learning and career development opportunities
Supportive, inclusive, and collaborative work culture
Opportunity to work with a company supporting the majority of newly approved global therapies
Over the past five years, Syneos Health has supported:
94% of all Novel FDA-Approved Drugs
95% of EMA-Authorized Products
200+ clinical studies across 73,000+ sites and 675,000+ trial participants
Additional Information
This job description is not exhaustive. Syneos Health reserves the right to modify responsibilities based on business needs. Equivalent combinations of education, skills, and experience may be considered. Employment practices comply with applicable global employment laws, including equal opportunity and disability accommodation requirements.
Job Summary
Under general supervision, the Regulatory Associate supports regulatory submissions, regulatory research, and product development activities. Responsibilities include the preparation and maintenance of documentation for INDs, NDAs, MAAs, DMFs, variations, renewals, and other post-approval lifecycle activities, with a focus on EU CMC Module 3 requirements.
Gujarat :
Ahmedabad | Ankleshwar | Baroda | Bharuch | Gandhinagar | Gujarat | Halol | Jhagadia | Mehsana | surat | Tarasadi | Vadodara | Vapi |Maharashtra :
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Siliguri |Illinois :
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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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Bangor | Brewer |New Jersey :
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Chandler | Kingman | Lake Havasu City | Mesa | Peridot | Phoenix | Surprise | Tempe | Tucson | Yuma |South Carolina :
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Concord | Lumberton | North Carolina |Michigan :
Detroit | Houghton Lake | Macomb | Southfield |North Dakota :
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 :
Fulton | Milan | St. Louis |United States :
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Lake Charles | Shreveport |Nevada :
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Lisbon | Oeiras | Portugal |WI :
Madison | Wausau |Republic of Mexico :
Mexico |northeastern :
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Oklahoma City |Puerto Rico :
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Tuscaloosa |D.C :
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Aachen | Bielefeld | Bochum | Bonn | Cologne | Dortmund | Duisburg | Dusseldorf | Munster |Munich :
Bavaria |Bavaria :
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Berlin |Baden-Wurttemberg :
Biberach an der Riß | Freiburg | Grenzach | Heidelberg | Karlsruhe | Konstanz | Stuttgart | Tubingen | Ulm |Hesse :
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Frankfurt | Harveysburg |Germany :
Germany | GErmany |Lower Saxony :
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Ingelheim am Rhein | Mainz |Schleswig Holstein :
Kiel |Berlin :
Mitte |Mecklenburg Vorpommern :
Rostock |Saarland :
Saarbrucken |Switzerland :
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 :
Norway | NOrway |Romania :
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Wavre |Tipperary :
Ballydine |Cork :
Brinny | Ringaskiddy |Carlow :
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Cork | Dublin | Limerick | Waterford |Ulster :
Donegal |Meath :
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Galway |County Dublin :
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China | Quarry Bay |Liaoning :
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Hangzhou |Tokiyo :
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Shanghai Shi |Hubei :
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Leiden |Netherlands :
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 :
Mississauga | Renfrew | North York | Uxbridge | Australia | Richmond Hill |Canada :
Canada |Quebec :
Montreal |Brussels :
Brussels |Antwerp :
Heist op den Berg |Flemish Brabant :
Zaventem |South America :
Peru | Argentina |Brazil :
Sao paulo | Brazil |Attica :
Athens | Koropi |Greece :
Greece |North Island :
Auckland |New Zealand :
New Zealand |Austria :
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 :
Hà Nội | Hanoi |Ho Chi Minh :
Ho Chi Minh City |Italy :
Italy |Lombardy :
Rho |Jakarta :
Jakarta |East Java :
Surabaya |Japan :
Japan | Saitama |Tokyo :
Otemachi |North Ostrobothnia :
Oulu |Southwest Finland (Varsinais-Suomi) :
Turku |Remote Korea :
Remote Korea |Republic of Korea :
Seoul |Kazakhstan :
Almaty |Republic of Thailand :
Bangkok |Israel :
Be'Er Sheva | Netanya | Kfar Saba | Yavne | Tel Aviv |Remote :
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Bucharest |Buenos Aires :
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Cairo |Mexico :
New Mexico | Ciudad de México |Dubai :
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Kyiv |Lima Region :
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Niš |Bohemia :
Prague |Chile :
Santiago |Bosnia and Herzegovina :
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