Job Title: Associate Regulatory Affairs (Module 1, Regulatory Submission)
Date Updated: 11 August 2025
Location: India – Remote
Job ID: 25100921
Employment Type: Full-time
About the Company:
Syneos Health® is a leading, fully integrated biopharmaceutical solutions provider, operating in 110+ countries with over 29,000 employees. The company partners with life sciences organizations to accelerate clinical development, regulatory submissions, and commercialization. In the past five years, Syneos Health has worked on 94% of FDA-approved novel drugs and 95% of EMA-authorized products.
Role Overview:
This role supports regulatory submissions and documentation for Module 1, focusing on country-specific administrative requirements, investigational and marketing applications, lifecycle management, and compliance activities. The position involves collaboration with regulatory teams, conducting research, and ensuring accurate submission tracking and archiving.
Key Responsibilities:
Prepare Module 1 documents and collect 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 queries and track commitments.
Maintain and update regulatory trackers, timelines, and status reports.
Archive submission documentation in line with internal SOPs.
Conduct regulatory research to identify precedents and support orphan drug designation requests.
Prepare reports, correspondence, and client-facing documents as required.
Collaborate with internal teams and provide regulatory information as needed.
Qualifications & Skills:
Master’s degree in Pharmaceutical Sciences.
~2 years’ experience in regulatory, quality, or document management roles.
Excellent interpersonal and communication skills.
Advanced proficiency in Microsoft Office.
Strong organizational and project/time management skills (preferred).
Exposure to regulatory tools such as Veeva RIM is advantageous.
Culture & Benefits:
Career growth and technical training opportunities.
“Total Self” culture promoting diversity, inclusion, and authenticity.
Recognition programs and comprehensive benefits.
Gujarat :
Ahmedabad | Ankleshwar | Baroda | Bharuch | Gandhinagar | Gujarat | Halol | Jhagadia | Mehsana | Tarasadi | Vadodara | Vapi |Maharashtra :
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Siliguri |Illinois :
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Appleton | Kenosha | Pleasant Prairie | Portage | Waukesha |United states :
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Frank Scottile Blvd |Missouri :
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Lima |France :
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