Syneos Health Hiring Sr Regulatory Associate (CMC)

Sr Regulatory Associate (CMC) at Syneos Health – Pune | M.Pharm or Life Sciences | 4+ Years Experience in CMC Dossiers & Regulatory Affairs

Looking for a career in global regulatory affairs? Syneos Health invites applications for the Sr Regulatory Associate (CMC) role at their Pune location. This position is ideal for professionals with a Master’s degree in Pharmaceutical or Life Sciences and 4+ years of experience in CMC dossier preparation, post-approval variations, and regulatory submissions.

Apply now to join a world-class team accelerating the delivery of novel therapies worldwide.

Join Syneos Health as Sr Regulatory Associate (CMC) – Pune

Syneos Health, a leading fully integrated biopharmaceutical solutions company, is hiring a Sr Regulatory Associate (CMC) in Pune, India. This full-time role offers an exciting opportunity to work with cross-functional teams and support global regulatory submissions across EU and RoW markets.

With access to cutting-edge technology and an inclusive work environment, Syneos Health offers career advancement, technical growth, and a culture where work here matters everywhere.

About Syneos Health

With a presence in over 110 countries and a team of 29,000+ professionals, Syneos Health supports 94% of all FDA Novel Drug Approvals and 95% of EMA Authorized Products. Its hybrid operating model blends clinical, medical, and commercial insights to deliver real-world results.

Join a company that champions diversity, continuous learning, and the development of your Total Self.

Key Responsibilities

Regulatory Dossier Preparation & Submissions

• Prepare, compile, and review high-quality CMC dossiers (Variations, Renewals, RTQs, Annual Reports)
• Ensure submissions meet ICH, FDA, EMA, and GMP compliance requirements
• Handle post-approval variation submissions (EU focus); MAA dossier experience preferred for RoW markets

Collaboration & Documentation

• Liaise with QA, QPs, Clinical Teams, and Global Regulatory Affairs
• Support regulatory change control and impact assessments
• Assist in creating SOPs, templates, and compliance reports
• Provide training and mentorship to junior associates as needed

Systems & Tools

• Use tools like RIMS, VEEVA Vault for regulatory document tracking
• Maintain submission databases and support commitments tracking

Required Qualifications

• Education: Master’s degree in Pharmaceutical Sciences or Life Sciences
• Experience: 4+ years in CMC regulatory affairs, especially in dossier preparation and global submissions
• Proficient with GMP guidelines, ICH regulations, and regulatory strategy
• Hands-on with RIMS/VEEVA Vault, Microsoft Office
• Strong communication and coordination skills across cross-cultural/virtual teams

Location & Work Environment

• Location: Pune, Maharashtra
• Work Type: Full-time (Hybrid/Onsite flexibility)
• Industry: Biopharmaceutical/Clinical Regulatory Affairs

Why Syneos Health?

• Competitive compensation with comprehensive benefits
• Opportunity to work with global top-tier clients
• Inclusive, development-driven work culture
• Proven success across major regulatory approvals

Call to Action

Apply now through Syneos Health’s official careers portal: https://www.syneoshealth.com/clinical-corporate-careers/jobs/16246070-sr-regulatory-associate-cmc?src=SNS-10160&bid=370

Submit a tailored resume that showcases your CMC regulatory experience and technical acumen.

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