Syneos Health, a global leader in biopharmaceutical solutions, is hiring for the position of Associate Regulatory Affairs (Module 1, Regulatory Submission).
This role offers an exciting opportunity to support global drug registration processes, regulatory document preparation, and lifecycle submission management — with the flexibility to work remotely or in a hybrid setup from Gurugram, India.
If you’re passionate about regulatory documentation, IND/NDA submissions, and health authority communications, this is your chance to grow with one of the world’s most respected CROs.
🧾 Key Responsibilities
As an Associate in Regulatory Affairs, you will:
- Prepare and assist with Module 1 documents and country-specific administrative forms.
- Support the creation of regulatory submission documents — including INDs, NDAs/MAAs, DMFs, variations, renewals, and MATs.
- Prepare responses to Health Authority queries and track commitments.
- Maintain regulatory trackers, submission timelines, and status reports.
- Ensure proper archiving of submission documentation and compliance with internal SOPs.
- Conduct regulatory research and assist in preparing orphan drug designation requests.
- Communicate effectively with clients and cross-functional teams to ensure submission accuracy and compliance.
🎓 Qualifications & Experience
To qualify for this opportunity, you should have:
- Master’s degree in Pharmaceutical Sciences (M.Pharm or equivalent).
- Around 2 years of experience in regulatory, quality, or document management support roles.
- Strong understanding of global regulatory submission requirements.
- Proficiency in Microsoft Office applications and good time/project management skills.
- Excellent interpersonal and communication abilities.
💼 Why Join Syneos Health
At Syneos Health, Work Here Matters Everywhere™.
You’ll be part of a dynamic, diverse, and innovative organization with a commitment to:
- Continuous learning and career development opportunities.
- A Total Self Culture, valuing authenticity and inclusion.
- Global exposure across 110+ countries and partnerships with 94% of FDA-approved drugs in the last 5 years.
- Recognition programs, wellness initiatives, and competitive compensation.
📝 How to Apply
