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.
Andra Pradesh :
Anakapali | Anantapur | Bhimavaram | Chittoor | Guntur | Gurgaon | Mangalagiri | Nellore | Pydibimavaram | Tirupathi | Vijayawada | Visakhapatnam |Assam :
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Ranchi |Karnataka :
B.G Nagara | Bangalore | Belgaum | Bengaluru | Bommasandra | Colorado | Czech Republic | Mangaluru | Mysore | Udupi |Kerala :
Kannur | Kochi | Malappuram | Thiruvananthapuram | Trivandrum |Madhya Pradesh :
Bhopal | Dewas | Gwalior | Indore | Khandwa | Khargone | Pithampur | Ujjain |Maharashtra :
Airoli | Ambernath | Amravati | Aurangabad | Dhule | Jalgaon | Kolhapur | Kurkumbh | Kurla | Madhapur | Mumbai | Nagpur | Nashik | Navi Mumbai | Pune | Pune city | Shirpur | Tandalja | Tarapur | Thane | Vikhroli | Yerawada |Odisha :
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Rangpo |Tamil Nadu :
Annamalainagar | Chennai | Coimbatore | Erode | Madurai | Nagercoil | Ooty | Pudupakkam | Srivilliputtur | Tiruchirappalli | Trichy | Vellore | Yogyakarta |Uttar Pradesh :
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Digha | Kolkata | Mukundapur |Alabama :
Birmingham |Alaska :
Anchorage | Barrow | Bethel | Juneau | Sitka | Wrangell |Albama :
Tuscaloosa |Arizona :
Chandler | Kingman | Lake Havasu City | Mesa | Peridot | Phoenix | Surprise | Tempe | Tucson | Yuma |Arkansas :
Fort Smith |California :
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Detroit | Houghton Lake | Macomb | Southfield |Minnesota :
Duluth | Eden Prairie | Fridley | Hibbing | Maple Grove | Minneapolis and St. Paul, Minnesota. | Minnetonka | St.Paul |Missouri :
Fulton | Milan | St. Louis |Nebraska :
Hebron | Nebraska City |Nevada :
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Dickinson |northeastern :
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Arizona | Buffalo Grove | Clayton | Downers Grove | fairmont | Georgia | Keene | Michigan | Mt. Pleasant | New Jersy | OH | Piedmont | Salisbury | United States | Whitesboro | Winston-Salem |United States :
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Big Piney | Cokeville |Baden-Wurttemberg :
Biberach an der Riß | Freiburg | Grenzach | Heidelberg | Karlsruhe | Konstanz | Stuttgart | Tubingen | Ulm |Bavaria :
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Wavre |BULGARIA :
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France | Latvia | Lendava | Leuven | Poland | Slovenia | Spain |Finland :
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Swords |Dún Laoghaire :
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Dunboyne |Republic of Ireland :
Cork | Dublin | Limerick | Waterford |Tipperary :
Ballydine |Ulster :
Donegal |China :
China | Quarry Bay |Hubei :
Wuhan |Liaoning :
Dalian |Republic of China :
Beijing |Shanghai Sai :
Shanghai Shi |Tokiyo :
Osaka | Tokyo |Zhejiang :
Hangzhou |Melbourne :
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Ballina | Sydney |Queensland :
Queensland |Remote Australia :
Arkansas | Remote Australia |Republic of Western Australia :
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Amsterdam |Netherlands :
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Haarlem |North Brabant :
Breda |South Holland :
Leiden |North Yorkshire :
Harrogate |Oxfordshire :
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Sheffield |United Kingdom :
England | Harlow | Leeds | London | Maidenhead | Salt Lake City | Stevenage | Stirling | United Kingdom |Buenos Aires :
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Vienna |Antwerp :
Heist op den Berg |Brussels :
Brussels |Flemish Brabant :
Zaventem |Bosnia and Herzegovina :
Sarajevo |Sofia City :
Sofia |Canada :
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Renfrew | Australia | Uxbridge | Richmond Hill | North York | Mississauga |Quebec :
Montreal |Chile :
Santiago |Republic of Colombia :
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Croatia |Zagreb :
Zagreb |Bohemia :
Prague |Republic of Egypt :
Cairo |Estonia :
Tartu | Estonia |Harju County (Maakond) :
Tallinn |Chuuk :
North Ostrobothnia :
Oulu |Southwest Finland (Varsinais-Suomi) :
Turku |France :
Lyon | Paris |Attica :
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Surabaya |Jakarta :
Jakarta |Israel :
Be'Er Sheva | Netanya | Kfar Saba | Tel Aviv | Yavne |Italy :
Italy |Lombardy :
Rho |Japan :
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Almaty |Remote Korea :
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Ciudad de México |North Island :
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Manila |Mazovia :
Warsaw |Remote :
Nairobi | Melbourne | Remote, USA | Riga | Leinster | Bishop | Ireland | Remote - South America (Latin Americal) | Blue Bell | Hammond | Slovakia | Lenexa | Medan | Switzerland | Remote | Hungary | Remote - Europe | Manipal | Lousiana | Belgium | Minnesota | Texas | Thailand | Tulsa | Xzagreb | Castlebar | Bountiful | Victoria | French | Zaragoza | McFarland | Remote - Africa | Faridabad | Remote - Middle East | Green Way | Springville |Bucharest :
Bucharest |Makkah :
Khulais | King Abdullah Economic City | Najran | Rabigh | Riyadh | Jeddah |Nišava District :
Niš |Singapore :
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Midrand | South Africa |Brazil :
Sao paulo | Brazil |South America :
Peru | Argentina |Catalonia :
Barcelona |Madrid :
Madrid |Sweden :
Sweden |Taipei :
Taipei |Williamson :
Brentwood |Republic of Thailand :
Bangkok |Kyiv Oblast :
Kyiv |Dubai :
Dubai |Hà Nội :
Hà Nội | Hanoi |Ho Chi Minh :
Ho Chi Minh City |