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.

Quick Overview Table

Company Name	Syneos Health
Current Vacancies	Sr Regulatory Associate (CMC)
Required Education	M.Pharm, Life Sciences
Experience Required	4+ Years in Regulatory Affairs (CMC Dossiers)
Location	Pune, Maharashtra, India