Senior Regulatory Associate – EU Market Experience
Updated: Yesterday
Location: Gurgaon, Haryana, India
Job ID: 25105062-OTHLOC-5206-2DH
Employment Type: Full-Time
About Syneos Health®
Syneos Health® is a leading fully integrated biopharmaceutical solutions organization focused on accelerating customer success. By combining deep expertise across clinical development, medical affairs, and commercialization, Syneos Health transforms scientific insights into meaningful outcomes that address evolving global healthcare and regulatory landscapes.
With a patient-centric Clinical Development model and operations across more than 110 countries, Syneos Health continuously simplifies processes to deliver innovative therapies faster and more efficiently. Our global teams collaborate in both Functional Service Provider (FSP) and Full-Service environments to support regulatory excellence worldwide.
Position Overview
The Senior Regulatory Associate – EU Market Experience plays a key role in supporting regulatory submissions and lifecycle management activities across the European Union and other international markets. This role requires hands-on experience in EU regulatory strategy, post-approval variations, and dossier authoring, with exposure to additional markets such as APAC and Gulf countries.
The position is ideal for regulatory professionals with strong execution capabilities, attention to detail, and experience working within global regulatory frameworks.
Key Responsibilities
Regulatory Submissions and Lifecycle Management
Prepare, compile, and submit regulatory applications and components for INDs, MAAs, and lifecycle maintenance activities in compliance with EU and global regulatory requirements
Support initial marketing authorization applications and post-approval variations, including renewals and marketing authorization transfers
Contribute to authoring, review, and maintenance of CTD Modules 2 and 3
Operational and Project Support
Execute regulatory activities for non-complex submissions independently; support complex submissions under guidance from senior regulatory colleagues
Perform high-quality information processing within defined timelines, SOPs, and regulatory standards
Maintain regulatory records, trackers, and databases in alignment with Syneos Health and client requirements
Conduct quality control reviews of regulatory documents and manage review cycles through final submission
Collaboration and Quality Oversight
Participate in client meetings and support client relationship management for assigned projects
Review work completed by Regulatory Associates and Senior Associates, providing feedback on quality and productivity
Identify risks related to workload or project delivery and escalate appropriately with proposed mitigation strategies
Assist in training, mentoring, and onboarding of team members as required by project needs
Compliance and Continuous Development
Ensure completion of all mandatory Syneos Health and client-specific training requirements
Maintain accurate individual training records and compliance documentation
Support audits and inspections by ensuring regulatory documentation is complete and submission-ready
Required Qualifications and Experience
Education
Bachelor’s degree (BS/BA) in life sciences, pharmacy, regulatory affairs, or a related discipline
Equivalent practical experience will be considered
Experience
Minimum 2–3 years of regulatory affairs experience with demonstrated exposure to the EU market
Hands-on experience with EU regulatory submissions, including post-approval variations and initial marketing authorization applications
Prior exposure to APAC and/or Gulf markets is highly desirable
Experience supporting or authoring CTD Modules 2 and 3
Skills and Competencies
Strong understanding of EU regulatory frameworks and lifecycle management 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 and manage multiple projects with varying requirements
Proven ability to collaborate effectively with cross-functional and global teams
Why Join Syneos Health?
Structured career development and progression opportunities
Access to technical, regulatory, and therapeutic-area training
Supportive leadership and a culture of continuous learning
Commitment to the Total Self culture, promoting inclusion, diversity, and well-being
Opportunity to contribute to high-impact regulatory programs supporting global drug development
Over the past five years, Syneos Health has supported:
94% of novel FDA-approved drugs
95% of EMA-authorized products
Over 200 clinical studies across 73,000 sites globally
Additional Information
Job responsibilities may evolve based on business and project requirements
Equivalent combinations of education, skills, and experience will be considered
This job description does not constitute an employment contract
Syneos Health is an equal opportunity employer and complies with all applicable employment and accessibility regulations
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