Senior Regulatory Associate – EU Market Experience
Location: Gurugram, India (Hybrid)
Job ID: 25105062
Category: Regulatory Affairs
ThePharmaDaily.com is pleased to feature this opportunity with Syneos Health, a globally recognized biopharmaceutical solutions organization accelerating clinical development, regulatory excellence, and commercialization strategies worldwide.
Syneos Health partners with leading pharmaceutical, biotechnology, and medical device companies to bring innovative therapies to market faster. With operations across 110+ countries, the organization integrates clinical development, medical affairs, and commercial expertise to drive measurable outcomes in global healthcare.
Position Overview
The Senior Regulatory Associate – EU Market Experience will play a critical role in supporting regulatory submissions and lifecycle management activities across the European Union and other international markets. This position is ideal for regulatory professionals with hands-on experience in EU marketing authorization applications, post-approval variations, and CTD dossier preparation.
The role requires strong knowledge of EU regulatory frameworks, high attention to detail, and the ability to manage multiple submissions within defined timelines.
Key Responsibilities
Prepare and submit regulatory applications and lifecycle maintenance submissions, including:
Initial Marketing Authorization Applications (MAA)
Post-approval variations
Renewals and lifecycle updates
Author and support CTD Modules 2 and 3 in compliance with EU regulatory requirements.
Support submissions across EU, APAC, and Gulf markets where applicable.
Perform high-quality information processing activities within strict timelines.
Maintain regulatory records, logs, and databases in alignment with company and client standards.
Conduct Quality Control (QC) reviews of regulatory documents prior to submission.
Track submission status and ensure timely delivery to health authorities or clients.
Identify project risks and escalate appropriately with proposed mitigation strategies.
Participate in client meetings and maintain professional client relationships.
Mentor junior regulatory associates as required.
Ensure compliance with ICH guidelines, EU directives, and applicable regulatory standards.
Education & Experience Required
Bachelor’s degree in Pharmacy, Life Sciences, or related field (Postgraduate degree preferred).
Minimum 2–3 years of hands-on experience in EU regulatory affairs.
Demonstrated experience in:
EU Market Authorization Applications (MAA)
Post-approval variations
Lifecycle maintenance activities
CTD Module 2 and 3 authoring/support
Exposure to APAC and Gulf regulatory markets is an advantage.
Experience working in CRO, pharmaceutical, or regulatory consulting environments preferred.
Technical & Professional Skills
Strong knowledge of EU regulatory frameworks and submission processes.
Familiarity with INDs, NDAs, MAAs, DMFs, MATs, and renewals.
Advanced proficiency in Microsoft Office applications.
Strong analytical, documentation, and quality review skills.
Excellent written and verbal communication skills in English.
Ability to manage multiple projects with varying regulatory requirements.
Strong attention to detail and compliance orientation.
Work Model
Hybrid – Gurugram, India
Why Consider This Role
This position offers exposure to global regulatory strategy, cross-functional collaboration, and multi-market submissions. It is a strategic opportunity for regulatory professionals looking to strengthen their EU regulatory expertise while contributing to international drug development programs.
Syneos Health is committed to diversity, inclusion, and equal opportunity employment. Candidates requiring accommodation during the application process are encouraged to request support as per company guidelines.
For more global Regulatory Affairs, Pharmacovigilance, Clinical Research, and Pharmaceutical industry opportunities, visit ThePharmaDaily.com.
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