In the ever-evolving landscape of biopharmaceutical development, regulatory professionals play a crucial role in ensuring the safety, quality, and compliance of drug products across global markets. Syneos Health, a global leader in fully integrated biopharmaceutical solutions, is currently seeking an Associate Regulatory Affairs (RA) – Module 3, CMC professional to join their team in Pune, Maharashtra.

This opportunity reflects Syneos Health’s commitment to accelerating drug development through innovation, collaboration, and operational excellence.

Associate RA ( Module 3, CMC)

Pune, Maharashtra, India

About Syneos Health

With a footprint in over 110 countries and a workforce of more than 29,000 employees, Syneos Health combines clinical development, medical affairs, and commercial solutions into a unified platform to address the needs of modern healthcare. The organization is driven by a deep focus on patients and customers, underpinned by its core values and the unique “Total Self” culture, which promotes authenticity, diversity, and inclusion.

Whether as a Functional Service Provider or within a Full-Service model, Syneos Health fosters a culture where “Work Here Matters Everywhere.”

The Role: Associate Regulatory Affairs – Module 3, CMC

The Associate RA will be part of a dynamic regulatory team, working on the preparation and submission of regulatory documents focused on Module 3 (Chemistry, Manufacturing, and Controls) for various lifecycle management activities. This includes CMC variations, renewals, annual reports, and legal entity name changes, ensuring compliance with global regulatory requirements.

Key Responsibilities:

• Independently prepare Module 3 sections for non-complex regulatory submissions.
• Draft and submit components of IND, marketing, and post-approval applications.
• Utilize regulatory systems like Veeva RIMS for submission planning and tracking.
• Maintain submission records and update internal regulatory databases.
• Conduct quality control (QC) checks on documents before submission.
• Collaborate with cross-functional teams and engage with clients when necessary.
• Mentor junior team members and support knowledge-sharing activities.

This role is ideal for professionals who can multitask, think analytically, and navigate the regulatory landscape with accuracy and timeliness.

What Syneos Health Is Looking For

Minimum Qualifications:

• Education: M.Pharm or MS in Life Sciences (or equivalent).
• Experience:
  • Minimum 6 months for Regulatory Associate level
  • Minimum 1.5 years for Senior Regulatory Associate level

Preferred Skills:

• Familiarity with Veeva RIMS and Trackwise.
• Advanced proficiency in Microsoft Office tools.
• Strong command of written and spoken English.
• Ability to manage multiple projects simultaneously.
• Excellent interpersonal and communication skills.

Why Join Syneos Health?

Working at Syneos Health means joining a company that values growth, learning, and inclusion. Employees benefit from:

• Clear career development paths
• Robust technical and therapeutic training
• A collaborative environment focused on well-being and work-life balance
• Global exposure and peer recognition programs

The organization is constantly working to be the company where employees want to work, and where clients want to partner.

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