Senior Regulatory Associate – EU Market Experience
Updated: Yesterday
Location: Pune, Maharashtra, India
Job ID: 25105062
Job Overview
Syneos Health® is a leading fully integrated biopharmaceutical solutions organization, partnering with customers to accelerate the development and delivery of innovative therapies worldwide. With a strong global footprint and deep regulatory expertise, Syneos Health supports regulatory submissions across the product lifecycle, enabling faster patient access to medicines.
We are currently seeking a Senior Regulatory Associate with European Union (EU) market experience to support regulatory submissions, post-approval activities, and lifecycle management across multiple global markets.
This role is ideal for regulatory professionals with hands-on experience in EU regulatory frameworks, dossier authoring, and post-marketing regulatory operations.
Experience Required
Minimum 2–3 years of hands-on experience in Regulatory Affairs
Demonstrated experience working with EU market submissions
Exposure to APAC and Gulf regulatory markets is highly preferred
Proven experience in post-approval variations and initial marketing authorization applications (MAA)
Practical experience supporting or authoring CTD Modules 2 and 3
Key Responsibilities
Regulatory Submissions & Lifecycle Management
Prepare, compile, and submit regulatory applications including INDs, MAAs, NDAs, variations, renewals, MATs, and lifecycle maintenance submissions in compliance with regional regulations
Independently manage non-complex regulatory submissions; support complex submissions under guidance from senior regulatory professionals
Ensure all submissions meet EU regulatory standards, timelines, and internal quality benchmarks
Documentation & Quality Control
Author, review, and quality-check regulatory documents to ensure accuracy, compliance, and consistency
Maintain regulatory records, submission logs, and databases as per Syneos Health and client requirements
Track documents through internal review cycles up to final submission or client delivery
Project & Stakeholder Support
Execute project-specific regulatory activities with minimal supervision, within agreed timelines and budgets
Participate in client meetings, supporting regulatory deliverables and fostering strong client relationships
Identify risks related to workload or timelines and escalate proactively with mitigation proposals
Team Collaboration & Training
Review work output of Regulatory Associates and Senior Associates as assigned
Support training, mentoring, and onboarding of team members based on project needs
Maintain individual training records and complete all mandatory Syneos Health and client-specific training
Qualifications & Skills
Education
Bachelor’s degree (BS/BA) in Life Sciences, Pharmacy, Biotechnology, or a related discipline
Equivalent practical regulatory experience will be considered
Core Competencies
Strong understanding of EU regulatory requirements and submission processes
Excellent written and verbal communication skills in English
Advanced proficiency in Microsoft Office applications
Strong analytical, organizational, and documentation skills
Ability to work independently while managing multiple projects concurrently
Proven ability to collaborate with cross-functional and global teams
Why Join Syneos Health
Work within a globally recognized organization supporting 95% of EMA-authorized products
Exposure to large-scale global regulatory programs across diverse therapeutic areas
Continuous learning through structured training, career development, and mentoring
Inclusive and supportive work culture built on diversity, equity, and belonging
About Syneos Health
Over the past five years, Syneos Health has supported:
94% of all novel FDA-approved drugs
95% of EMA-authorized products
Over 200 clinical studies across 73,000 sites and 675,000+ patients
Syneos Health operates across 110+ countries with a workforce of over 29,000 professionals dedicated to transforming clinical, medical, and commercial outcomes.
Disclaimer
The responsibilities listed are not exhaustive and may be modified based on business needs. Syneos Health reserves the right to determine equivalent qualifications and experience. This job description does not constitute an employment contract. The company is committed to equal employment opportunity and compliance with applicable employment legislation.
Gujarat :
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Siliguri |Illinois :
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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 :
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Europe | France | Latvia | Lendava | Leuven | Poland | Slovenia | Spain |Finland :
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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 :
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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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Peru | Argentina |Brazil :
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Greece |North Island :
Auckland |New Zealand :
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Barcelona |Madrid :
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Tartu | Estonia |Harju County (Maakond) :
Tallinn |Hà Nội :
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Japan | Saitama |Tokyo :
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Almaty |Republic of Thailand :
Bangkok |Israel :
Be'Er Sheva | Netanya | Kfar Saba | Yavne | Tel Aviv |Remote :
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Kuala Lumpur |Kyiv Oblast :
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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