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Are you looking to build a career in regulatory affairs with one of the world’s leading biopharmaceutical solutions organizations? Syneos Health is hiring Associate RA (Module 1, regulatory submission) for its India team (Remote/Gurugram Hybrid). This is your chance to contribute to global regulatory submissions and grow your career in a high-impact role.
Syneos Health is known for working on 94% of all FDA-approved novel drugs and 95% of EMA-authorized products in the last 5 years. Now you can be part of their success story.
📌 Job Responsibilities
As an Associate Regulatory Affairs professional, you will:
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- Assist in preparing Module 1 documents and country-specific administrative forms.
- Support regulatory submissions including INDs, NDAs, MAAs, DMFs, variations, renewals, MATs, and lifecycle maintenance.
- Prepare responses to Health Authority (HA) queries and track commitments.
- Maintain regulatory trackers, submission timelines, and compliance documentation.
- Conduct regulatory research to support orphan drug designation requests.
- Archive submission documents in line with SOPs.
- Provide client support, prepare reports, and draft regulatory correspondence.
🎓 Qualification Requirements
- Master’s degree in Pharmaceutical Sciences.
- Around 2 years of experience in regulatory, quality, or document management support.
- Strong interpersonal and communication skills.
- Advanced proficiency in Microsoft Office.
- Good project and time management skills (preferred).
🌟 Why Join Syneos Health?
At Syneos Health, you will experience:
- Career growth with training, mentorship, and progression opportunities.
- A supportive and inclusive culture built on the Total Self philosophy.
- The chance to work on cutting-edge therapies and regulatory submissions worldwide.
- Recognition through rewards programs and global exposure across 110+ countries.
📝 How to Apply
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