Regulatory Consultant
Location: India-Asia Pacific – IND-Home-Based
Updated: April 28, 2025
Job ID: 25003301
About Syneos Health:
Syneos Health® is a fully integrated biopharmaceutical solutions organization built to accelerate customer success through clinical, medical affairs, and commercial insights. Our Clinical Development model focuses on simplifying operations and improving collaborations with both customers and employees. With a global team of over 29,000 employees across 110 countries, we deliver innovative solutions that drive the development of life-changing therapies.
Why Join Us:
Career growth and advancement opportunities
Supportive and engaged line management
Access to technical and therapeutic area training
Recognition programs and total rewards
Inclusive “Total Self” culture that supports authenticity and well-being
Diverse and global workforce that fosters a strong sense of belonging
Job Responsibilities:
For both non-complex and complex submissions, the Regulatory Consultant will:
Conduct product data research aligned with global/regional regulatory requirements to develop gap analyses and product development plans
Prepare technical and administrative components for regulatory submissions including INDs, pre-approval packages, registration applications, and post-approval maintenance
Support regulatory meetings and agency interactions with briefing packages
Manage regulatory activities and ensure adherence to timelines, budgets, and contractual scope
Serve as regulatory support on cross-functional teams involving clinical and technical specialists
Troubleshoot daily project issues and provide solutions
Contribute to proposals and regulatory service estimations
Participate in client meetings for ongoing project updates and business development
Ensure global regulatory compliance and internal process adherence
Prepare internal/external training materials and contribute to SOPs and procedural documentation
Offer oversight and guidance to junior team members as required
Assist in audits and internal initiatives as regulatory support
Maintain training records and complete designated learning activities
Preferred Experience:
Strong knowledge of Life Cycle Management (LCM)
Hands-on experience with post-approval submissions for Global ROW/EU
Familiarity with change control assessments and regulatory strategy documentation
Qualifications:
BS or PhD in a science-related field or equivalent experience in regulatory/medical writing
Proven experience with regulatory submissions (e.g., IND, NDA, MAA, PMA, CTD)
Familiarity with electronic submissions
Strong written and verbal communication skills
High-quality customer service and ability to collaborate or work independently
Experience with quality management processes
Advanced proficiency in Microsoft Office
Analytical, detail-oriented, adaptable, and proactive
Strong multitasking and project-specific compliance skills
Fluency in English (written and spoken)
Note:
The duties and responsibilities outlined are not exhaustive. Syneos Health may modify or assign additional duties as necessary. Qualifications may be adjusted based on equivalent experience or educational background. This job description adheres to global labor regulations and inclusion directives.
Andra Pradesh :
Anakapali | Anantapur | Bhimavaram | Chittoor | Guntur | Gurgaon | Mangalagiri | Nellore | Pydibimavaram | Tirupathi | Vijayawada | Visakhapatnam |Assam :
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Ahmedabad | Ankleshwar | Baroda | Bharuch | Gandhinagar | Halol | Jhagadia | Mehsana | Tarasadi | Vadodara | Vapi |Haryana :
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Baddi | Solan |India :
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Ranchi |Karnataka :
B.G Nagara | Bangalore | Belgaum | Bengaluru | Bommasandra | 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 | Mumbai | Nagpur | Nashik | Navi Mumbai | Pune | Pune city | Shirpur | Tarapur | Thane | Vikhroli |Odisha :
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Rangpo |Tamil Nadu :
Annamalainagar | Chennai | Coimbatore | Erode | Madurai | Nagercoil | Ooty | Pudupakkam | Srivilliputtur | Tiruchirappalli | Trichy | Vellore |Uttar Pradesh :
Gajraula | Gautam buddha Nagar | Ghaziabad | Gorakhpur | Greater Noida | Jhansi | Lucknow | Mathura | Noida | Park City | Prayagraj | Varanasi |Uttarakhand :
Dehradun | Halifax | Nainital | Rishikesh | Roorkee |West Bengal :
Digha | Kolkata | Mukundapur |Alabama :
Birmingham |Alaska :
Anchorage | Barrow | Bethel | Juneau | Sitka | Wrangell |Albama :
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Chandler | Kingman | Lake Havasu City | Mesa | Peridot | Phoenix | Surprise | Tempe | Tucson | Yuma |Arkansas :
Fort Smith |California :
Adelanto | Alameda | Albion | Arcata | Atherton | Berkeley | Brisbane | Burlingame | Burney | California | Carlsbad | Crescent City | Davis | Downey | El Monte | El Segundo | Emeryville | Eureka | Fortuna | Foster City | Fremont | Glendale | Hayward | Hoopa | Irvine | La Jolla | Los Angeles | Martinez | McKinleyville | Menlo Park | Millbrae | Milpitas | Morgan Hill | Mountain View | Nevada | Novato | Oakland | Orange | Pacheco | Palo Alto | Pasadena | Pleasanton | Pomona | Redding | Redwood City | Riverside | Roseville | Sacramento | San Bernardino | San Carlos | San Diego | San Francisco | San Gabriel | San Jose | San Mateo | San Rafael | Santa Clara | Santa Cruz | Santa Monica | Simi Valley | Soledad | South San Francisco | St. Helena | Stanford | Stanton | Stockton | Sunnyvale | Temecula | Thousand Oaks | Valencia | Vallejo | West Sacramento | West Valley City | Whittier | Willits |Colorado :
Boulder | Denver | Westminster |Connecticut :
Bridgeport | Bristol | Enfield | Groton | Hartford | New Haven | Newtown | South Windsor | Stamford | Storrs | West Hartford |D.C :
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Wilmington |Florida :
Boca Raton | Brooksville | Clearwater | Cooper City | Coral Gables | Coral Springs | Daytona Beach | Gainesville | Hollywood | Jacksonville | Maitland | Miami | Naples | North Miami Beach | Orlando | Pembroke Pines | Plantation | Port St. Lucie | Rueil-Malmaison | Saint Petersburg | Sarasota | Stuart | Tallahassee | Tampa | West Palm Beach | Winter Haven |Georgia :
Atlanta | Augusta | Rome |Hawaii :
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Andover | Billerica | Boston | Cambridge | Devens | Lexington | Massachusetts | Medford and Somerville | Rockland |Michigan :
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 :
Las Vegas | Tonopah | Tonopsh | Virginia |New Hampshire :
Lebanon | Macon | Manchester |New Jersey :
Basking Ridge | Bloomfield | Branchburg Township | Bridgewater | Brunswick | Burlington | Charlotte | Clark | Cranbury | Dunellen | East Brunswick | Edison | Fairfield | Far Hills | Flemington | Hackensack | Hopewell | Indianapolis | Jersey City | Linden | Livingston | Lyndhurst | Mahwah | Monmouth Junction | Montville | Mount Arlington | New Brunswick | Newark | Nutley | Paramus | Parsippany | Passaic | Paterson | Peapack-Gladstone | Pine Brook | Piscataway Township | Plainsboro | Princeton Junction | Rahway | Raritan | Somerset | Somerville | South Plainfield | Sparta | Summit | Titusville | Trenton | Warren Grove | West Orange | Westfield | Wharton | Whippany |New Mexico :
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Albany | Biddle | Brooklyn | Buffalo | Hauppauge | Hawthorne | Hicksville | Ithaca | Middleburgh | Morningside Heights | New York | Pearl River | Poughkeepsie | Rensselaer | Rhinebeck | Syracuse | Utica | Watertown |North Carolina :
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Dickinson |northeastern :
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Batavia | Blue Ash | Cincinnati | Cleveland | Columbus, | Dayton | Erie | Evendale | Franklin | Hamilton | Huber Heights | Kings Mills | Macedonia | Mason | Milford | Montgomery | Norwood | Oregoina | oxford | Waynesville |Oklahoma :
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Bend | Coquille | Corvallis | Eugene | Florence | Grants Pass | John Day | Lake Oswego | Lakeview | Portland | Reedsport | Roseburg | Salem | Springfield | Woodburn |Pennsylvania :
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fairmont | Georgia | Keene | OH | United States |United States :
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Dunboyne |Republic of Ireland :
Cork | Dublin | Limerick | Waterford |Tipperary :
Ballydine |Ulster :
Donegal |China :
China | Quarry Bay |Hubei :
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Dalian |Republic of China :
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Osaka | Tokyo |Zhejiang :
Hangzhou |Melbourne :
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Ballina | Sydney |Queensland :
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Breda |South Holland :
Leiden |North Yorkshire :
Harrogate |Oxfordshire :
Witney |South Yorkshire :
Sheffield |United Kingdom :
England | Harlow | Leeds | London | Maidenhead | Salt Lake City | Stevenage | Stirling | United Kingdom |Buenos Aires :
Buenos Aires |Austria :
Austria |Vienna :
Vienna |Antwerp :
Heist op den Berg |Brussels :
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Zaventem |Bosnia and Herzegovina :
Sarajevo |Sofia City :
Sofia |Canada :
Canada |Ontario :
Uxbridge | Richmond Hill | Mississauga | North York | Renfrew |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 :
Koropi | Athens |Greece :
Greece |East Java :
Surabaya |Jakarta :
Jakarta |Israel :
Be'Er Sheva | Netanya | Yavne | Kfar Saba | Tel Aviv |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 :
McFarland | Remote - Middle East | Victoria | Melbourne | Switzerland | Remote - South America (Latin Americal) | Remote - Europe | Remote, USA | Remote - Africa | Remote | Lenexa |Bucharest :
Bucharest |Makkah :
Rabigh | King Abdullah Economic City | Najran | Riyadh | Khulais | 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 :
Hanoi | Hà Nội |Ho Chi Minh :
Ho Chi Minh City |