Job Title:
Regulatory Associate (EU Market)
Location:
Remote – India
Company:
Syneos Health
Preferred Experience:
Minimum 1 year in global regulatory affairs (CMC). Internships considered.
Compensation:
Not specified
Job Summary
Syneos Health is seeking a proactive and detail-oriented Regulatory Associate to support global regulatory operations, especially for the EU market. This remote role based in India is ideal for candidates with hands-on CMC dossier preparation and global regulatory experience. Join a globally respected CRO, contribute to life-changing therapies, and grow your regulatory career in a fast-paced environment.
Key Responsibilities
Prepare and review global regulatory dossiers, including CMC submissions, variations, and post-approval changes
Assist in developing product regulatory documents (e.g., INDs, NDAs, MAAs, DMFs)
Conduct regulatory research across multiple markets (EU, US, LATAM, APAC, MEA, China)
Support lifecycle maintenance activities including renewals and authorization transfers
Perform quality checks and regulatory documentation reviews
Collaborate with clients and internal teams to ensure compliance and submission readiness
Compile and report regulatory data and insights as required
Required Skills & Qualifications
Minimum 1 year of global regulatory affairs experience (CMC preferred)
Master's in Pharmacy (preferred), or a Master’s in science/healthcare field
Internships in regulatory affairs (CMC) are considered an asset
Proficient in regulatory dossier development for multiple regions
Strong command of Microsoft Office applications
Excellent written and spoken English
Strong project and time management skills
Detail-oriented with strong analytical and communication skills
Ability to work both independently and collaboratively
Perks & Benefits
Remote work flexibility
Career development and growth opportunities
Global exposure to regulatory markets
Collaborative and inclusive company culture
Training in regulatory tools and methodologies
Total rewards and peer recognition programs
Company Description
Syneos Health is a global biopharmaceutical services company, supporting over 94% of FDA novel drug approvals in the past 5 years. With operations in 110 countries, Syneos leads in clinical development, regulatory consulting, and commercial delivery, accelerating therapies that improve patient lives.
Work Mode
Remote
Call-to-Action
Join a mission-driven team shaping the future of regulatory science. If you're eager to contribute to global healthcare impact, apply now and advance your career at Syneos Health.
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