Job Title:
Regulatory Consultant – EU Market Experience
Location: Remote (India)
Company: Syneos Health
Job Summary:
Syneos Health is hiring an experienced Regulatory Consultant with minimum 6 years of CMC regulatory affairs experience in the EU market. This is a fully remote opportunity ideal for professionals in pharmaceutical regulatory affairs, particularly with hands-on experience in Module 3 authoring, post-approval variations, and Veeva Vault/RIMS platforms. You will play a vital role in ensuring compliance, managing lifecycle submissions, and contributing to regulatory strategy for global product portfolios.
Key Responsibilities:
Author and review Module 3 CMC documents for regulatory submissions
Manage post-approval CMC variations and lifecycle maintenance
Support regulatory strategy and submission planning for EU markets
Use RIMS/Veeva Vault for documentation management and troubleshooting
Conduct regulatory gap analysis and prepare submission documentation (IND, MAA, CTD)
Participate in client meetings and contribute to regulatory proposals
Provide mentorship and subject matter expertise to internal teams
Ensure adherence to global regulatory standards and timelines
Support internal and external audits and training development
Collaborate with multidisciplinary teams across global functions
Required Skills & Qualifications:
Minimum 6 years of experience in regulatory affairs with CMC focus
Strong experience in EU regulatory submissions and post-approval changes
Proficiency in RIMS, Veeva Vault, and electronic submission systems
Bachelor’s or PhD in a science-related field
Knowledge of CTD structure, ICH guidelines, and global regulatory frameworks
Strong communication and project management skills
Fluent in English (spoken and written)
Excellent attention to detail and problem-solving ability
Ability to manage multiple projects independently
Perks & Benefits:
Remote work flexibility (India-based role)
Global career progression opportunities
Access to cross-functional training and certifications
Competitive total rewards and peer recognition program
Inclusive, diverse workplace culture
Supportive leadership and mentorship
About Syneos Health:
Syneos Health is a global biopharmaceutical solutions company supporting drug development and commercialization across over 110 countries. With 29,000+ professionals worldwide, we lead innovations in clinical trials, regulatory strategy, and product lifecycle management. We have supported over 94% of all FDA-approved drugs in the last five years and work with over 200 clinical studies annually.
Work Mode:
Remote – India-based candidates only
Call to Action:
Ready to advance your regulatory career with a global pharma leader?
Apply now to join Syneos Health as a Regulatory Consultant – EU Market and be part of a mission to accelerate therapies worldwide.
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