Regulatory Operations Expert
Location: Mumbai, India
Category: Clinical / Regulatory Affairs
Employment Type: Full-Time
Experience Required: 3–5 years
Job Overview
We are seeking a Regulatory Operations Expert to join our Mumbai team to manage regulatory affairs and project management activities for Fortrea clients. This role involves overseeing the creation, revision, compilation, and approval of regulatory and labeling documents across the product lifecycle for submissions to health authorities in the US, EU, Japan, and other global regions.
The position also includes team management responsibilities, including performance reviews, resource allocation, and mentoring junior staff to ensure high-quality, compliant, and cost-effective services for both internal and external clients.
Key Responsibilities
Manage and coordinate regulatory operations for regulatory and labeling documentation, ensuring submissions meet client expectations and regulatory timelines.
Oversee creation, revision, and approval of documents such as protocols, reports, method qualification/validation, and investigative documentation.
Support team members in delivering regulatory services across client projects or as stand-alone business functions.
Manage Corrective/Preventive Actions (CAPA), Change Controls, and Quality Issues associated with internal and contract laboratories.
Participate in quality oversight activities, including QA boards, quality improvement programs, and team meetings to promote continuous process improvement.
Foster a quality-driven culture, ensuring compliance with cGMP and ICH guidelines across all regulatory activities.
Collaborate effectively across organizational boundaries, cultures, and global teams to influence decision-making and achieve project objectives.
Provide leadership in process standardization, document management, and regulatory compliance, ensuring alignment with global best practices.
Contribute to departmental objectives, support resource allocation, and assist Senior Management in strategic planning and project execution.
Required Qualifications & Experience
Education: Bachelor’s or Master’s degree in Pharmaceutical, Chemical, or Biological Sciences or equivalent experience in the pharmaceutical industry.
Experience: 3–5 years in regulatory operations, quality assurance, pharmaceutical development, or laboratory environment (including method development, validation, stability testing, and instrument qualification).
Strong understanding of cGMP, ICH guidelines, and global regulatory requirements.
Proven ability to influence, negotiate, and collaborate across global teams and diverse cultures.
Excellent verbal and written communication skills in English.
Demonstrates agile mindset, adaptability, and proactive problem-solving.
Experience in fostering a quality and compliance culture within a regulated environment.
Preferred Skills
Knowledge of IT systems, automation, and laboratory management.
Exposure to regional and global health authority submissions.
Leadership and mentoring experience in team or project management.
Work Environment & Travel
Office-based in Mumbai, India, with potential for remote work as needed.
Travel: 5–10% regional or global travel, including overnight stays, as project requirements dictate.
Andra Pradesh :
Anakapali | Anantapur | Bhimavaram | Chittoor | Guntur | Gurgaon | Mangalagiri | Nellore | Pydibimavaram | Tirupathi | Vijayawada | Visakhapatnam |Assam :
Dibrugarh | Diburghar | Guwahati |Bihar :
Hajipur | Patna |Chhattisgarh :
Bilaspur | Eot Municipality | Raipur |Delhi :
Delhi | India | New Delhi | PAN-India |Goa :
Goa | Panaji | Verna |Gujarat :
Ahmedabad | Ankleshwar | Baroda | Bharuch | Gandhinagar | Gujarat | Halol | Jhagadia | Mehsana | Tarasadi | Vadodara | Vapi |Haryana :
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Baddi | Solan |India :
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B.G Nagara | Bangalore | Belgaum | Bengaluru | Bommasandra | Colorado | Czech Republic | Karnataka | Mangaluru | Mysore | Udupi |Kerala :
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Digha | Kolkata | Mukundapur |Alabama :
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Chandler | Kingman | Lake Havasu City | Mesa | Peridot | Phoenix | Surprise | Tempe | Tucson | Yuma |Arkansas :
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Boise |Illinois :
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Bangor | Brewer |Maryland :
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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 :
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Bayreuth | Erlangen | Munich | Regensburg | Wurzburg |Berlin :
Mitte |Brandenburg :
Berlin |Germany :
Germany | GErmany |Hesse :
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Frankfurt | Harveysburg |Lower Saxony :
Gottingen | Hannover | Leipzig |Mecklenburg Vorpommern :
Rostock |Munich :
Bavaria |North Rhine Westphalia :
Aachen | Bielefeld | Bochum | Bonn | Cologne | Dortmund | Duisburg | Dusseldorf | Munster |Rhineland Palatinate :
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Saarbrucken |Saxony Anhalt :
Halle |Schleswig Holstein :
Kiel |Belgium :
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Bulgaria | Vedant |Denmark :
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Europe | France | Latvia | Lendava | Leuven | Poland | Slovenia | Spain |Finland :
Finland |Hungary :
Budapest |Istanbul :
Istanbul | Turkey |Norway :
Norway | NOrway |Romania :
Romania |Serbia :
Belgrade | Serbia |Switzerland :
Basel | Zurich |Carlow :
Carlow |Cork :
Brinny | Ringaskiddy |County Dublin :
Swords |Dún Laoghaire :
Dún Laoghaire |Galway :
Galway |Meath :
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 :
South Yarra |New South Wales :
Ballina | Sydney |Queensland :
Queensland |Remote Australia :
Arkansas | Remote Australia |Republic of Western Australia :
Nedlands |Capital of Netherland :
Amsterdam |Netherlands :
Netherlands |Noord Holland :
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 :
Buenos Aires |Austria :
Austria |Vienna :
Vienna |Antwerp :
Heist op den Berg |Brussels :
Brussels |Flemish Brabant :
Zaventem |Bosnia and Herzegovina :
Sarajevo |Sofia City :
Sofia |Canada :
Canada |Ontario :
Australia | North York | Renfrew | Mississauga | Uxbridge | Richmond Hill |Quebec :
Montreal |Chile :
Santiago |Republic of Colombia :
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Croatia |Zagreb :
Zagreb |Bohemia :
Prague |Republic of Egypt :
Cairo |Estonia :
Estonia | Tartu |Harju County (Maakond) :
Tallinn |Chuuk :
North Ostrobothnia :
Oulu |Southwest Finland (Varsinais-Suomi) :
Turku |France :
Paris | Lyon |Attica :
Athens | Koropi |Greece :
Greece |East Java :
Surabaya |Jakarta :
Jakarta |Israel :
Kfar Saba | Netanya | Tel Aviv | Yavne | Be'Er Sheva |Italy :
Italy |Lombardy :
Rho |Japan :
Japan | Saitama |Tokyo :
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Almaty |Remote Korea :
Remote Korea |Republic of Korea :
Seoul |Kuala Lumpur :
Kuala Lumpur |Mexico :
Ciudad de México | New Mexico |New Zealand :
New Zealand |North Island :
Auckland |Lima Region :
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Manila |Mazovia :
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Jeddah | Rabigh | Riyadh | Khulais | Najran | King Abdullah Economic City |Nišava District :
Niš |Singapore :
Singapore |South Africa :
Midrand | South Africa |Brazil :
Sao paulo | Brazil |South America :
Peru | Argentina |Catalonia :
Barcelona |Madrid :
Madrid |Sweden :
Sweden |Taipei :
Taipei |Williamson :
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