Regulatory Affairs Consultant – Remote, India
Experience Level: Senior / Experienced Professional (8–10 years)
Job Type: Full-Time, Permanent, Remote
About the Role
As a Regulatory Affairs Consultant at Parexel, you will play a pivotal role in guiding biopharmaceutical and medical device companies through complex regulatory pathways. Leveraging your scientific, technical, and regulatory expertise, you will support clients in developing and implementing regulatory strategies that accelerate product approvals and maintain market compliance. This role offers exposure to diverse product types and therapeutic areas while providing opportunities for continuous learning and career advancement.
Key Responsibilities
Manage regulatory submissions, including new registrations, life cycle management, and renewals for biologicals, vaccines, recombinant proteins, monoclonal antibodies, plasma-derived products, and small molecules across key global markets (US, EU, Japan, Canada, Switzerland, Australia).
Contribute to the preparation, authoring, and delivery of Marketing Authorization Applications (MAAs), variations, and regulatory documents from both global and regional perspectives.
Ensure compliance with global regulatory frameworks and ICH guidelines, including Chemistry, Manufacturing, and Controls (CMC) requirements.
Stay current with regional regulatory trends and requirements, providing strategic recommendations to clients.
Collaborate effectively with cross-functional teams, clients, and external stakeholders to resolve regulatory issues and maintain high-quality deliverables.
Maintain strong communication channels to ensure timely project updates and client satisfaction.
Required Skills and Competencies
In-depth knowledge of regulatory affairs for both small and large molecules, including life cycle management and product renewals.
Strong analytical, problem-solving, and decision-making abilities.
Excellent communication and interpersonal skills with the ability to work independently and collaboratively across global teams.
Strategic mindset with attention to detail and results-oriented approach.
Ability to manage multiple regulatory projects simultaneously, prioritizing tasks and meeting deadlines.
Experience Required
8–10 years of relevant experience in global regulatory affairs, handling regulatory submissions and lifecycle management across US, EU, Japan, Canada, Switzerland, and Australia.
Proven experience with Marketing Authorization Applications, variations, and compliance with global pharmaceutical legislation and guidance.
Education
Advanced degree in Life Sciences, Pharmacy, or Medicine (PhD, MD, PharmD, or equivalent).
Why Join Parexel?
Work in a patient-focused, global organization delivering high-quality, timely regulatory solutions.
Flexible remote work arrangements with global exposure.
Collaborate with an experienced team of regulatory professionals providing mentorship and guidance.
Opportunities for continuous learning, career growth, and working on diverse products across therapeutic areas.
Inclusive and supportive work environment that values innovation, collaboration, and excellence.
Apply Now to become a key member of Parexel Consulting and advance your career in global regulatory affairs.
Uttar Pradesh :
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Kannur | Kochi | Malappuram | Thiruvananthapuram | Trivandrum |Pondicherry (Puducherry) :
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Ranchi |Sikkim :
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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 :
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 | Newark | New Brunswick | 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 | Westfield | West Orange | Wharton | Whippany |Ohio :
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Bellevue | Bothell | Friday Harbor | Goldendale | Mount Vernon | Pullman | Seattle | Sherwood | Tacoma | Vancouver |Oregon :
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Big Piney | Cokeville |Alabama :
Birmingham |Virginia :
Blacksburg | Charlottesville | Falls Church | Mechanicsville |Indiana :
Bloomington | West Lafayette |Florida :
Boca Raton | Brooksville | Clearwater | Cooper City | Coral Gables | Coral Springs | Daytona Beach | Florida | Gainesville | Hollywood | Jacksonville | Maitland | Marsa | 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 |Idaho :
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Concord | Lumberton | North Carolina |Michigan :
Detroit | Houghton Lake | Macomb | Southfield |North Dakota :
Dickinson |Minnesota :
Duluth | Eden Prairie | Fridley | Hibbing | Maple Grove | Minneapolis and St. Paul, Minnesota. | Minnetonka | St.Paul |Kentucky :
Edgewood | Ft MItchell | Louisville | Shelbyville |Arkansas :
Fort Smith |Kington :
Frank Scottile Blvd |Missouri :
Fulton | Milan | St. Louis |United States :
Hawai | kentucky | Sylmar | Woonsocket |Nebraska :
Hebron | Nebraska City |Hawaii :
Hilo | Honolulu |Tennessee :
Knoxville | Memphis | Nashville |Louisiana :
Lake Charles | Shreveport |Nevada :
Las Vegas | Tonopah | Tonopsh | Virginia |New Hampshire :
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Lisbon | Oeiras | Portugal |WI :
Madison | Wausau |Republic of Mexico :
Mexico |northeastern :
New Hampshire |Oklahoma :
Oklahoma City |Puerto Rico :
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Washington |Delaware :
Wilmington |North Rhine Westphalia :
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Bavaria |Bavaria :
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Germany | GErmany |Lower Saxony :
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Mitte |Mecklenburg Vorpommern :
Rostock |Saarland :
Saarbrucken |Switzerland :
Basel | Zurich |Serbia :
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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 :
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Wavre |Tipperary :
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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 :
Beijing |China :
China | Quarry Bay |Liaoning :
Dalian |Zhejiang :
Hangzhou |Tokiyo :
Osaka | Tokyo |Shanghai Sai :
Shanghai Shi |Hubei :
Wuhan |Capital of Netherland :
Amsterdam |North Brabant :
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Haarlem |South Holland :
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 :
Uxbridge | Renfrew | Mississauga | Richmond Hill | North York | Australia |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 :
Almaty |Republic of Thailand :
Bangkok |Israel :
Kfar Saba | Netanya | Be'Er Sheva | Tel Aviv | Yavne |Remote :
Thailand | Hungary | Minnesota | Victoria | Belgium | Remote - South America (Latin Americal) | Remote, USA | Xzagreb | Leinster | Remote - Middle East | Bishop | Remote | Springville | Castlebar | Nairobi | Blue Bell | Regulatory Labeling Manager (NA and LATAM Only) | Hammond | Manipal | Green Way | McFarland | Slovakia | Ireland | Bountiful | Medan | Lousiana | Melbourne | Riga | Switzerland | Zaragoza | French | Tulsa | Lenexa | Remote - Africa | Remote - Europe | Texas | Faridabad |Republic of Colombia :
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Bucharest |Buenos Aires :
Buenos Aires |Republic of Egypt :
Cairo |Mexico :
Ciudad de México | New Mexico |Dubai :
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Riyadh | Najran | Jeddah | Rabigh | King Abdullah Economic City | Khulais |Kuala Lumpur :
Kuala Lumpur |Kyiv Oblast :
Kyiv |Lima Region :
Lima |France :
Paris | Lyon |South Africa :
South Africa | Midrand |Nišava District :
Niš |Bohemia :
Prague |Chile :
Santiago |Bosnia and Herzegovina :
Sarajevo |Singapore :
Singapore |Sofia City :
Sofia |Sweden :
Sweden |Taipei :
Taipei |Mazovia :
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