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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.
Job Overview Table:
| Field | Details |
|---|---|
| Job Title | Associate Regulatory Affairs (Module 3, CMC) |
| Location | Pune, Maharashtra, India |
| Company | Syneos Health |
| Industry | Biopharmaceutical Services |
| Experience Required | 6+ months (Associate) / 1.5+ years (Sr. Associate) |
| Education | M.Pharm / MS (Pharmaceutical or Life Sciences) |
| Key Responsibilities | Module 3 submissions, CMC variations, lifecycle management |
| Preferred Tools | Veeva RIMS, Microsoft Office, Trackwise |
| Skills | English communication, analytical thinking, multitasking |
| Why Join | Global exposure, career growth, diverse culture |
| Application Link | Syneos Health Careers |
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