Regulatory Associate
Location: IND-Gurugram
Job ID: 25101793
Company Overview
Syneos Health® is a fully integrated biopharmaceutical solutions organization that accelerates customer success by translating clinical, medical affairs, and commercial insights into actionable outcomes. Their Clinical Development model places the customer and patient at the center of all activities.
They foster a culture of innovation, collaboration, and agility to accelerate therapy delivery while simplifying processes for employees and clients alike.
Why Syneos Health
Career development and progression through training, mentoring, and technical guidance.
Inclusive Total Self culture promoting authenticity and belonging.
Recognition programs and total rewards.
Commitment to diversity of thought, background, and perspectives.
Job Summary
The Regulatory Associate supports regulatory agency submissions, regulatory research, and product development under supervision. Responsibilities include preparation of submission documents for INDs, NDAs/MAAs, DMFs, variations, renewals, MATs, and other lifecycle maintenance activities.
Key Responsibilities
Regulatory Documentation & Submission Support:
Assist with preparation of product development documents, including gap analyses and clinical development plans.
Assist with regulatory submission documents: INDs, NDAs/MAAs, DMFs, variations, renewals, MATs, and lifecycle maintenance activities.
Conduct regulatory research to identify precedents and support orphan drug designation requests.
Perform quality checks on regulatory documents.
Assist clients, internal teams, and stakeholders with general regulatory information.
Data Gathering & Reporting:
Gather, compile, analyze, and report information.
Search files and records, make contacts, and prepare detailed reports and routine correspondence.
Qualifications & Experience
Education:
Bachelor’s degree in science/healthcare field or equivalent combination of education and experience.
Skills & Competencies:
Excellent interpersonal and communication skills.
Advanced Microsoft Office skills (Word, Excel, PowerPoint).
Strong analytical skills and attention to detail.
Time and project management capabilities.
Ability to work independently and as part of a team.
Ability to handle multiple projects with differing instructions.
Fluency in English (speaking, reading, writing).
Preferred Experience:
Previous experience in regulatory affairs or clinical development is advantageous.
Additional Information
Posting is for an upcoming potential opportunity, not a live role. Expressing interest adds you to the talent pipeline.
Tasks and responsibilities may vary at the company’s discretion.
Syneos Health is committed to diversity, inclusion, and compliance with all applicable employment regulations, including the ADA.
Company Impact
Worked with 94% of all novel FDA-approved drugs and 95% of EMA-authorized products over the past 5 years.
Supported 200+ studies across 73,000 sites and 675,000+ trial patients.
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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Hajipur | Patna |Kerala :
Kannur | Kochi | Malappuram | Thiruvananthapuram | Trivandrum |Pondicherry (Puducherry) :
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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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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Detroit | Houghton Lake | Macomb | Southfield |North Dakota :
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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 :
Fulton | Milan | St. Louis |United States :
Hawai | kentucky | Sylmar | Woonsocket |Nebraska :
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Mexico |northeastern :
New Hampshire |Oklahoma :
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Ingelheim am Rhein | Mainz |Schleswig Holstein :
Kiel |Berlin :
Mitte |Mecklenburg Vorpommern :
Rostock |Saarland :
Saarbrucken |Switzerland :
Basel | Zurich |Serbia :
Belgrade | Serbia |Hungary :
Budapest |BULGARIA :
Bulgaria | Vedant |Denmark :
Copenhagen | Denmark |Europe :
Europe | France | Latvia | Lendava | Leuven | Poland | Slovenia | Spain |Finland :
Finland |Istanbul :
Istanbul | Turkey |Norway :
Norway | NOrway |Romania :
Romania |Belgium :
Wavre |Tipperary :
Ballydine |Cork :
Brinny | Ringaskiddy |Carlow :
Carlow |Republic of Ireland :
Cork | Dublin | Limerick | Waterford |Ulster :
Donegal |Meath :
Dunboyne |Dún Laoghaire :
Dún Laoghaire |Galway :
Galway |County Dublin :
Swords |Republic of China :
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China | Quarry Bay |Liaoning :
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Osaka | Tokyo |Shanghai Sai :
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Amsterdam |North Brabant :
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Haarlem |South Holland :
Leiden |Netherlands :
Netherlands |Remote Australia :
Arkansas | Remote Australia |New South Wales :
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Nedlands |Queensland :
Queensland |Melbourne :
South Yarra |United Kingdom :
England | Harlow | Leeds | London | Maidenhead | Salt Lake City | Stevenage | Stirling | United Kingdom |North Yorkshire :
Harrogate |South Yorkshire :
Sheffield |Oxfordshire :
Witney |Ontario :
Mississauga | North York | Australia | Uxbridge | Renfrew | Richmond Hill |Canada :
Canada |Quebec :
Montreal |Brussels :
Brussels |Antwerp :
Heist op den Berg |Flemish Brabant :
Zaventem |South America :
Argentina | Peru |Brazil :
Brazil | Sao paulo |Attica :
Athens | Koropi |Greece :
Greece |North Island :
Auckland |New Zealand :
New Zealand |Austria :
Austria |Vienna :
Vienna |Catalonia :
Barcelona |Madrid :
Madrid |Cebu Province :
Cebu City |Philippines :
Manila |Croatia :
Croatia |Zagreb :
Zagreb |Estonia :
Tartu | Estonia |Harju County (Maakond) :
Tallinn |Hà Nội :
Hanoi | Hà Nội |Ho Chi Minh :
Ho Chi Minh City |Italy :
Italy |Lombardy :
Rho |Jakarta :
Jakarta |East Java :
Surabaya |Japan :
Japan | Saitama |Tokyo :
Otemachi |North Ostrobothnia :
Oulu |Southwest Finland (Varsinais-Suomi) :
Turku |Remote Korea :
Remote Korea |Republic of Korea :
Seoul |Kazakhstan :
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Bangkok |Israel :
Yavne | Kfar Saba | Netanya | Be'Er Sheva | Tel Aviv |Remote :
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Kyiv |Lima Region :
Lima |France :
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Midrand | South Africa |Nišava District :
Niš |Bohemia :
Prague |Chile :
Santiago |Bosnia and Herzegovina :
Sarajevo |Singapore :
Singapore |Sofia City :
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Sweden |Taipei :
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