Job Title: Associate Regulatory Affairs (Module 1, Regulatory Submission)
Date Updated: 11 August 2025
Location: Gurugram, India (Hybrid)
Job ID: 25100921
Employment Type: Full-time
About the Company:
Syneos Health® is a global, fully integrated biopharmaceutical solutions provider that accelerates customer success through clinical, medical affairs, and commercial expertise. Operating in over 110 countries with a team of 29,000, Syneos Health has contributed to 94% of all novel FDA-approved drugs and 95% of EMA-authorized products in the past five years.
Role Overview:
The Associate Regulatory Affairs professional will assist in preparing Module 1 regulatory documents and country-specific administrative forms, supporting submissions for INDs, NDAs/MAAs, DMFs, and lifecycle maintenance activities. This role requires strong organizational skills, attention to detail, and familiarity with regulatory processes and tools.
Key Responsibilities:
Assist in the preparation of Module 1 documents and country-specific administrative forms.
Support the preparation of regulatory submissions, including INDs, NDAs/MAAs, DMFs, variations, renewals, and marketing authorization transfers (MATs).
Prepare responses to Health Authority queries and track commitments.
Maintain regulatory trackers, submission timelines, and status reports.
Ensure proper archiving of submission documentation in compliance with SOPs.
Conduct regulatory research to identify precedents and support orphan drug designation requests.
Prepare detailed reports and compose routine correspondence as needed.
Assist clients and internal stakeholders with regulatory information.
Qualifications & Skills:
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 applications.
Good time management and project management skills preferred.
Exposure to regulatory tools such as Veeva RIM is a plus.
Work Environment & Culture:
Emphasis on career growth, training, and mentorship.
“Total Self” culture that supports diversity, authenticity, and inclusion.
Estimated Salary: ₹5–8 LPA (based on entry-to-mid-level RA roles in India, hybrid)
Gujarat :
Ahmedabad | Ankleshwar | Baroda | Bharuch | Gandhinagar | Gujarat | Halol | Jhagadia | Mehsana | Tarasadi | Vadodara | Vapi |Maharashtra :
Airoli | Ambernath | Amravati | Aurangabad | Dhule | Dombivali | Jalgaon | Kolhapur | Kurkumbh | Kurla | Madhapur | Mumbai | Nagpur | Nashik | Navi Mumbai | Pune | Pune city | Shirpur | Tandalja | Tarapur | Thane | Vikhroli | Yerawada |Haryana :
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Baddi | Solan |Rajasthan :
Banasthali | Bhiwadi | Jaipur | Pilani | Udaipur |Karnataka :
Bangalore | Belgaum | Bengaluru | B.G Nagara | Bommasandra | Colorado | Czech Republic | Karnataka | Mangaluru | Mysore | Udupi |Punjab :
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Delhi | India | New Delhi | PAN-India |Assam :
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Digha | Kolkata | Mukundapur |Uttar Pradesh :
Gajraula | Gautam buddha Nagar | Ghaziabad | Gorakhpur | Greater Noida | Jhansi | Lucknow | Mathura | Noida | Park City | Prayagraj | Satyamev | Varanasi |Goa :
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Pondicherry (Puducherry) |Jharkhand :
Ranchi |Sikkim :
Rangpo |India :
Siliguri |Illinois :
Abbott Park | Bloomingdale | Champaign | Chicago | Deerfield | Glenview | Lake Forest | Lombard | Naperville | Norridge | Park RIdge | Round Lake |Maryland :
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Anchorage | Barrow | Bethel | Juneau | Sitka | Wrangell |Massachusetts :
Andover | Billerica | Boston | Cambridge | Devens | Lexington | Massachusetts | Medford and Somerville | Rockland |Wisconsin :
Appleton | Kenosha | Pleasant Prairie | Portage | Waukesha |United states :
Arizona | Buffalo Grove | Clayton | Downers Grove | fairmont | Georgia | Keene | Michigan | Mt. Pleasant | New Jersy | OH | Piedmont | Salisbury | United States | Whitesboro | Winston-Salem |Georgia :
Atlanta | Augusta | Rome |Maine :
Bangor | Brewer |New Jersey :
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Duluth | Eden Prairie | Fridley | Hibbing | Maple Grove | Minneapolis and St. Paul, Minnesota. | Minnetonka | St.Paul |Kentucky :
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Frank Scottile Blvd |Missouri :
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Witney |Ontario :
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Argentina | Peru |Brazil :
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Tallinn |Hà Nội :
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