Regulatory Associate (EU Market) – Hybrid (Gurugram)
Job Summary
Syneos Health is hiring a Regulatory Associate for the EU market with at least 1 year of experience in Global Regulatory Affairs. This hybrid position, based in Gurugram, offers an exciting opportunity to work on global CMC dossiers, variation applications, and post-approval lifecycle activities. Ideal for pharmaceutical professionals aiming to grow in regulatory affairs within a dynamic, international biopharma environment.
Key Responsibilities
Prepare and review CMC dossiers, variation applications, and post-approval regulatory submissions.
Conduct regulatory research for precedent identification and orphan drug designation.
Assist in INDs, NDAs/MAAs, DMFs, and lifecycle maintenance activities.
Perform document quality checks and compile regulatory data and reports.
Coordinate cross-functional information gathering to support regulatory documentation.
Provide general support and information to internal stakeholders and clients.
Required Skills & Qualifications
Master’s in Pharmacy (preferred) or related science/healthcare discipline.
Minimum 1 year experience in Global Regulatory Affairs (internship experience considered).
Knowledge of regulatory markets across EU, US, LATAM, APAC, Middle East, Africa, and China.
Strong proficiency in Microsoft Office.
Strong communication and analytical skills.
Fluent in written and spoken English.
Ability to multitask and follow detailed instructions.
Perks & Benefits
Hybrid work flexibility (based in Gurugram, India).
Global exposure to top regulatory markets.
Continuous learning through training and career development.
Peer recognition and rewards programs.
Inclusive and supportive work culture promoting diversity and authenticity.
Company Description
Syneos Health is a leading biopharmaceutical solutions company partnering with clients to accelerate the development and delivery of therapies worldwide. With a presence in over 110 countries and involvement in 94% of all novel FDA drug approvals in the past 5 years, we are committed to clinical excellence and innovation.
Work Mode: Hybrid (Gurugram, India)
Ready to Accelerate Your Career?
Join one of the most recognized teams in regulatory affairs. Apply now to be part of Syneos Health’s mission to change lives through clinical innovation.
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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Bilaspur | Eot Municipality | Raipur |Uttarakhand :
Dehradun | Halifax | Nainital | Rishikesh | Roorkee |Delhi :
Delhi | India | New Delhi | PAN-India |Assam :
Dibrugarh | Diburghar | Guwahati |West Bengal :
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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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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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Frank Scottile Blvd |Missouri :
Fulton | Milan | St. Louis |United States :
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Germany | GErmany |Lower Saxony :
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Saarbrucken |Switzerland :
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Bulgaria | Vedant |Denmark :
Copenhagen | Denmark |Europe :
Europe | France | Latvia | Lendava | Leuven | Poland | Slovenia | Spain |Finland :
Finland |Istanbul :
Istanbul | Turkey |Norway :
Norway | NOrway |Romania :
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Wavre |Tipperary :
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Brinny | Ringaskiddy |Carlow :
Carlow |Republic of Ireland :
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Donegal |Meath :
Dunboyne |Dún Laoghaire :
Dún Laoghaire |Galway :
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China | Quarry Bay |Liaoning :
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Osaka | Tokyo |Shanghai Sai :
Shanghai Shi |Hubei :
Wuhan |Capital of Netherland :
Amsterdam |North Brabant :
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Leiden |Netherlands :
Netherlands |Remote Australia :
Arkansas | Remote Australia |New South Wales :
Ballina | Sydney |Republic of Western Australia :
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 :
Renfrew | Mississauga | North York | Australia | Richmond Hill | Uxbridge |Canada :
Canada |Quebec :
Montreal |Brussels :
Brussels |Antwerp :
Heist op den Berg |Flemish Brabant :
Zaventem |South America :
Argentina | Peru |Brazil :
Brazil | Sao paulo |Attica :
Koropi | Athens |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 :
Estonia | Tartu |Harju County (Maakond) :
Tallinn |Hà Nội :
Hà Nội | Hanoi |Ho Chi Minh :
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Japan | Saitama |Tokyo :
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Seoul |Kazakhstan :
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Cairo |Mexico :
New Mexico | Ciudad de México |Dubai :
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Kyiv |Lima Region :
Lima |France :
Paris | Lyon |South Africa :
South Africa | Midrand |Nišava District :
Niš |Bohemia :
Prague |Chile :
Santiago |Bosnia and Herzegovina :
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