Syneos Health, a leading global biopharmaceutical solutions organization, is hiring for the position of Associate Regulatory Affairs (Module 3, CMC). This role offers a chance to work on CMC regulatory submissions, lifecycle maintenance, and compliance activities that directly impact the availability of innovative therapies worldwide.
Whether you prefer a remote setup or hybrid model in Gurugram, India, this opportunity gives you the platform to grow in a collaborative and innovative environment.
Key Responsibilities
As an Associate RA (Module 3, CMC), you will:
- Prepare Module 3 sections for post-approval CMC variations, renewals, annual reports, and other lifecycle activities.
- Submit components of IND, marketing, and lifecycle applications to ensure compliance with global regulations.
- Work with RIM systems like Veeva RIMS and Trackwise for content planning and submission tracking.
- Conduct quality control reviews of documents, ensuring accuracy and regulatory compliance.
- Manage regulatory databases and project-specific documentation.
- Attend client meetings, build strong relationships, and support deliverables.
- Identify risks to project delivery, propose solutions, and escalate when necessary.
- Mentor junior team members as needed and maintain updated training records.
Qualifications
To be eligible for this role, candidates should have:
- Education: M.Pharm/MS (or equivalent).
- Experience: Minimum 6 months for Regulatory Associate; 1.5+ years for Senior Regulatory Associate.
- Strong analytical and communication skills.
- Hands-on experience with Veeva RIMS, Trackwise preferred.
- Proficiency in Microsoft Office applications.
- Ability to work independently and handle multiple projects.
- Fluency in English (reading, writing, speaking).
Why Join Syneos Health?
At Syneos Health, you’ll be part of a 29,000+ global workforce across 110 countries, working on projects that have supported 94% of all FDA-approved novel drugs in the last 5 years. Benefits include:
- Career development and progression opportunities.
- Technical and therapeutic area training.
- Supportive and collaborative team culture.
- Hybrid/remote working flexibility.
- Recognition programs and rewards.
Application Process
