Regulatory Consultant – EU Market (CMC Module 3)
Updated: Yesterday
Location: Pune, Maharashtra, India
Job ID: 25105260
Employment Type: Full-Time
About Syneos Health
Syneos Health® is a leading fully integrated biopharmaceutical solutions organization focused on accelerating customer success. By combining clinical development, medical affairs, and commercial expertise, Syneos Health delivers innovative, patient-centric solutions that address evolving global market needs. With a presence across more than 110 countries and a workforce of over 29,000 professionals, the organization supports the development and commercialization of therapies that change lives worldwide.
Position Overview
The Regulatory Consultant – EU Market (CMC Module 3) provides regulatory and technical expertise to support pharmaceutical product development and post-approval lifecycle activities. This role focuses on CMC regulatory documentation (Module 3) for small molecule products, with primary responsibility for European Union (EU) regulatory submissions and additional exposure to GCC markets.
Key Responsibilities
Independently manage regulatory activities for non-complex and complex submissions in compliance with EU and global regulatory requirements
Author, review, and update CMC Module 3 documentation, including post-approval variations and lifecycle management submissions
Conduct regulatory research and assess existing product data to prepare gap analyses, development plans, and submission strategies
Prepare and contribute to regulatory submissions such as INDs, NDAs, MAAs, CTDs, and post-approval maintenance filings
Develop briefing packages for regulatory agency meetings and scientific advice procedures, and support agency interactions
Manage day-to-day regulatory deliverables for assigned projects, ensuring alignment with approved timelines, scope, budgets, and regulatory strategies
Provide regulatory support on cross-functional and multidisciplinary project teams throughout the product lifecycle
Act as a subject matter expert, supporting team members with regulatory guidance and issue resolution
Prepare regulatory effort estimates for proposals and support business development activities
Participate in client meetings to discuss proposals, project status, and regulatory strategies
Ensure compliance with global regulatory requirements, internal policies, and quality standards
Contribute to the development and maintenance of SOPs, training materials, and best practice documentation
Support internal and external audits and inspections as required
Provide oversight and mentoring support to junior team members
Maintain individual training records and complete all mandatory Syneos Health and client-specific training
Required Experience
4–5 years of relevant experience in Regulatory Affairs within the pharmaceutical or biopharmaceutical industry
Demonstrated experience in CMC Module 3 authoring, including post-approval variations and lifecycle management activities
Hands-on experience with EU regulatory submissions; exposure to GCC markets is preferred
Educational Qualifications
M.Pharm degree is mandatory
Bachelor’s, Master’s, or PhD in Pharmacy, Life Sciences, Chemistry, or a related scientific discipline may be considered with relevant experience
Required Skills and Competencies
Strong knowledge of EU regulatory frameworks, ICH guidelines, and global submission requirements
Proven experience contributing to regulatory submissions such as IND, NDA, MAA, PMA, and CTD, including electronic submissions
Excellent written and verbal communication skills in English
Strong analytical ability with high attention to detail and quality standards
Ability to manage multiple regulatory projects simultaneously with varying requirements
Proficiency in Microsoft Office applications
Strong interpersonal and collaboration skills across global, cross-functional teams
Proactive, adaptable, and solution-oriented mindset
Why Join Syneos Health
Opportunity to work on global regulatory projects supporting innovative therapies
Exposure to complex EU and international regulatory environments
Strong focus on professional development, training, and career progression
Inclusive, diverse, and collaborative work culture
Over the past five years, Syneos Health has supported:
94% of all Novel FDA-approved drugs
95% of EMA-authorized products
200+ studies across 73,000+ sites and 675,000+ trial participants worldwide
Additional Information
This job description is not intended to be exhaustive. Responsibilities may evolve based on business needs. Equivalent combinations of education, skills, and experience may be considered. Syneos Health is an equal opportunity employer and complies with all applicable employment and disability accommodation regulations.
Job Summary
The Regulatory Consultant provides regulatory and technical support for assigned product development projects, contributing to CMC documentation and regulatory agency submissions. This role implements and manages regulatory activities, supports cross-functional teams, and ensures compliance with global regulatory standards throughout the product lifecycle.
Gujarat :
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Atlanta | Augusta | Rome |Maine :
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Frank Scottile Blvd |Missouri :
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Lake Charles | Shreveport |Nevada :
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Lisbon | Oeiras | Portugal |WI :
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Bavaria |Bavaria :
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Biberach an der Riß | Freiburg | Grenzach | Heidelberg | Karlsruhe | Konstanz | Stuttgart | Tubingen | Ulm |Hesse :
Darmstadt | Marburg |Hessen :
Frankfurt | Harveysburg |Germany :
Germany | GErmany |Lower Saxony :
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Rostock |Saarland :
Saarbrucken |Switzerland :
Basel | Zurich |Serbia :
Belgrade | Serbia |Hungary :
Budapest |BULGARIA :
Bulgaria | Vedant |Denmark :
Copenhagen | Denmark |Europe :
Europe | France | Latvia | Lendava | Leuven | Poland | Slovenia | Spain |Finland :
Finland |Istanbul :
Istanbul | Turkey |Norway :
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China | Quarry Bay |Liaoning :
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Netherlands |Remote Australia :
Arkansas | Remote Australia |New South Wales :
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Nedlands |Queensland :
Queensland |Melbourne :
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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 :
Montreal |Brussels :
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Zaventem |South America :
Peru | Argentina |Brazil :
Sao paulo | Brazil |Attica :
Athens | Koropi |Greece :
Greece |North Island :
Auckland |New Zealand :
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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 :
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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 :
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Kyiv |Lima Region :
Lima |France :
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Midrand | South Africa |Nišava District :
Niš |Bohemia :
Prague |Chile :
Santiago |Bosnia and Herzegovina :
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