Senior Regulatory Associate – EU Market Experience
Updated: Yesterday
Location: Pune, Maharashtra, India
Job ID: 25105062
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 end-to-end solutions that support the development and commercialization of innovative therapies worldwide. With over 29,000 employees across 110 countries, Syneos Health plays a critical role in advancing global healthcare.
Position Overview
The Senior Regulatory Associate – EU Market Experience supports global and regional regulatory activities with a strong focus on European Union (EU) markets. This role is responsible for contributing to regulatory submissions, post-approval lifecycle management, and quality control activities across multiple regions, including EU, APAC, and Gulf countries. The position requires hands-on experience in regulatory documentation, coordination with cross-functional teams, and compliance with international regulatory requirements.
Required Experience
Minimum 2–3 years of experience in Regulatory Affairs
Proven experience supporting EU market regulatory submissions
Exposure to APAC and Gulf (GCC) markets is preferred
Hands-on experience with post-approval variations and initial Marketing Authorisation Applications (MAA)
Prior involvement in authoring or supporting CTD Module 2 and Module 3
Key Responsibilities
Regulatory Submissions and Lifecycle Management
Prepare and submit full applications or components of INDs, MAAs, NDAs, and lifecycle maintenance submissions in compliance with applicable regulatory requirements
Support post-approval activities, including variations, renewals, and marketing authorisation updates
Assist in the preparation, review, and compilation of regulatory documentation for EU and other global markets
Documentation and Quality Control
Perform quality control (QC) reviews of regulatory documents, ensuring accuracy, completeness, and compliance with internal and external standards
Track documents through review cycles until final submission or delivery to clients
Maintain regulatory records, logs, and databases in accordance with Syneos Health and client requirements
Project Execution and Collaboration
Execute project-specific regulatory activities with minimal supervision, ensuring adherence to timelines, budgets, and contractual commitments
Identify risks related to workload or delivery timelines and escalate appropriately with proposed mitigation strategies
Participate in client meetings as required and support the development of strong client relationships
Team Support and Mentorship
Review the work of Regulatory Associates and Senior Associates, supporting quality, consistency, and productivity
Assist in training and mentoring junior team members based on project needs
Maintain individual training records and complete all required Syneos Health and client-mandated training
Qualifications and Skills
Bachelor’s degree (BS/BA) in a scientific discipline, pharmacy, life sciences, or equivalent practical experience
Strong understanding of EU regulatory frameworks and lifecycle management processes
Excellent written and verbal communication skills in English
Strong analytical ability with attention to detail and accuracy
Proficiency in Microsoft Office applications (Word, Excel, PowerPoint)
Ability to work independently while managing multiple projects with varying requirements
Strong interpersonal skills and ability to collaborate across cross-functional and multicultural teams
Why Join Syneos Health
Opportunity to work on global regulatory submissions supporting innovative therapies
Exposure to diverse regulatory markets including EU, APAC, and GCC regions
Structured career development, technical training, and mentoring support
Inclusive and collaborative work culture focused on professional growth and quality excellence
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 over 675,000 clinical trial participants worldwide
Additional Information
The responsibilities outlined are not exhaustive and may evolve based on business needs. Equivalent experience and education may be considered. Syneos Health is an equal opportunity employer and is committed to compliance with all applicable employment and accessibility legislation.
Job Summary
Under limited supervision, the Senior Regulatory Associate supports regulatory submissions and compliance activities across EU and global markets. The role involves preparing and reviewing regulatory documentation, conducting quality control checks, coordinating project activities, and contributing to lifecycle management submissions in alignment with regulatory standards and client expectations.
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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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Frankfurt | Harveysburg |Germany :
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Basel | Zurich |Serbia :
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Bulgaria | Vedant |Denmark :
Copenhagen | Denmark |Europe :
Europe | France | Latvia | Lendava | Leuven | Poland | Slovenia | Spain |Finland :
Finland |Istanbul :
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China | Quarry Bay |Liaoning :
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Netherlands |Remote Australia :
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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 :
Montreal |Brussels :
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Zaventem |South America :
Peru | Argentina |Brazil :
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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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Japan | Saitama |Tokyo :
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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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New Mexico | Ciudad de México |Dubai :
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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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Singapore |Sofia City :
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