Clinical Project Assistant
SanofiÂ
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Job Description
Location: Pune, Maharashtra, India
Job ID: Not specified
Introduction
Syneos Health® is a leading fully integrated biopharmaceutical solutions organization dedicated to accelerating customer success. The company combines clinical, medical affairs, and commercial expertise to deliver innovative outcomes that address modern market realities. With over 29,000 employees across 110 countries, Syneos Health places the customer and the patient at the center of everything it does—driving collaboration, innovation, and excellence in drug development.
Role & Responsibilities
- Assist in the preparation of Module 1 documents and collection of country-specific administrative forms.
- Support the preparation of regulatory submission documents including INDs, NDAs/MAAs, DMFs, variations, renewals, and MATs.
- Prepare responses to Health Authority (HA) queries and track HA commitments as per current regulations and guidelines.
- Maintain and update regulatory trackers, submission timelines, and status reports.
- Ensure proper archiving of submission documentation and adherence to internal SOPs.
- Conduct regulatory research to identify precedents and support orphan drug designation requests.
- Gather information from various sources to prepare reports and routine correspondence.
- Assist clients and internal teams with regulatory information and documentation support.
Educational Qualification
- Master’s degree in Pharmaceutical Sciences or related field.
- Around 2 years of experience in regulatory, quality, or document management support roles.
- Strong interpersonal and communication skills.
- Advanced proficiency in Microsoft Office applications.
- Good time management and project coordination skills.
- Familiarity with regulatory tools such as Veeva RIM (preferred).
Location
 Pune, Maharashtra, India
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