Regulatory Intelligence Manager – FSP (Fully Remote, US)
Job ID: R-01334925
Location: United States (Fully Remote; East Coast Preferred)
Job Type: Full-Time
Category: Clinical Research
About the Role
The Regulatory Intelligence Manager will serve as a strategic leader within Thermo Fisher Scientific’s PPD® clinical research portfolio, providing expert guidance on global regulatory developments. This role is critical in monitoring, analyzing, and communicating regulatory updates that impact drug development pipelines, ensuring that cross-functional teams are informed and aligned with evolving requirements.
As a part of a global CRO operating in over 100 countries, this role supports innovative clinical trials and decentralized research frameworks, enabling the development of life-changing therapies.
Key Responsibilities
Regulatory Monitoring & Analysis: Track global regulatory changes, guidance documents, policy updates, and trends across key markets including FDA, EMA, PMDA, and international agencies (EU Commission, ICH, ISO).
Impact Assessment: Evaluate the potential implications of regulatory updates on the client’s clinical development programs, operational practices, and compliance requirements.
Stakeholder Alignment: Collaborate closely with Regulatory Affairs, Clinical, Quality, Pharmacovigilance, and Legal teams to ensure awareness and proactive management of emerging regulatory risks.
Communication & Reporting: Develop and disseminate internal newsletters, alerts, and briefing documents; contribute to internal knowledge platforms for efficient regulatory intelligence sharing.
Precedent Research: Conduct and support regulatory precedent searches and draft informed responses for internal stakeholders.
Knowledge Management: Maintain a centralized repository of regulatory intelligence resources, ensuring accessibility and usability across teams.
External Engagement: Participate in industry forums, working groups, and regulatory networks to identify emerging trends and best practices.
Qualifications and Experience
Bachelor’s degree in Life Sciences, Pharmacy, or a related field; advanced degree preferred.
Minimum 5+ years of experience in regulatory intelligence or regulatory affairs within the biopharmaceutical industry.
Strong understanding of global regulatory frameworks, drug development lifecycle, and clinical trial requirements.
Proven ability to translate complex regulatory information into actionable insights for operational teams.
Excellent analytical, writing, and presentation skills; fluency in English is mandatory.
Experience with regulatory intelligence platforms (e.g., Clarivate, Citeline) and familiarity with generative AI applications in regulatory workflows.
Strong project management, prioritization, and cross-functional collaboration skills.
Equivalency: In certain cases, a combination of education, training, and relevant experience may satisfy the role requirements.
Why Join Thermo Fisher Scientific / PPD?
Thermo Fisher Scientific empowers teams to accelerate research, develop innovative therapies, and deliver measurable impact on global health. Benefits of this role include:
Opportunity to lead regulatory intelligence initiatives in a global CRO environment.
Fully remote work with a supportive, flexible, and collaborative culture.
Exposure to cutting-edge AI and digital tools for regulatory strategy and intelligence.
Professional growth within a global organization of 100,000+ colleagues, emphasizing integrity, innovation, intensity, and involvement.
This role is ideal for professionals seeking to leverage regulatory expertise, shape strategic decisions, and influence global drug development programs.
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 | Karnataka | Mangaluru | Mysore | Udupi |Kerala :
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Bhopal | Dewas | Gwalior | Indore | Khandwa | Khargone | Pithampur | Ujjain |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 |Odisha :
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Bathinda | Bela | Chandigarh | ludhiana | Moga | Mohali | Patiala | Phagwara | Rajpura |Rajasthan :
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Rangpo |Tamil Nadu :
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Dehradun | Halifax | Nainital | Rishikesh | Roorkee |West Bengal :
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 :
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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 :
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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 :
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Albuquerque | Farmington | Santa Fe | Tucumcari |New York :
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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Bend | Coquille | Corvallis | Eugene | Florence | Grants Pass | John Day | Lake Oswego | Lakeview | Portland | Reedsport | Roseburg | Salem | Springfield | Woodburn |Pennsylvania :
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Mexico |South Carolina :
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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 :
Hawai | kentucky | Sylmar | Woonsocket |Virginia :
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Appleton | Kenosha | Pleasant Prairie | Portage | Waukesha |Wyoming :
Big Piney | Cokeville |Baden-Wurttemberg :
Biberach an der Riß | Freiburg | Grenzach | Heidelberg | Karlsruhe | Konstanz | Stuttgart | Tubingen | Ulm |Bavaria :
Bayreuth | Erlangen | Munich | Regensburg | Wurzburg |Berlin :
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Rostock |Munich :
Bavaria |North Rhine Westphalia :
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Ingelheim am Rhein | Mainz |Rotherbaum :
Hamburg |Saarland :
Saarbrucken |Saxony Anhalt :
Halle |Schleswig Holstein :
Kiel |Belgium :
Wavre |BULGARIA :
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Copenhagen | Denmark |Europe :
Europe | France | Latvia | Lendava | Leuven | Poland | Slovenia | Spain |Finland :
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Budapest |Istanbul :
Istanbul | Turkey |Norway :
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Basel | Zurich |Carlow :
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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 :
Witney |South Yorkshire :
Sheffield |United Kingdom :
England | Harlow | Leeds | London | Maidenhead | Salt Lake City | Stevenage | Stirling | United Kingdom |Buenos Aires :
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Austria |Vienna :
Vienna |Antwerp :
Heist op den Berg |Brussels :
Brussels |Flemish Brabant :
Zaventem |Bosnia and Herzegovina :
Sarajevo |Sofia City :
Sofia |Canada :
Canada |Ontario :
North York | Richmond Hill | Australia | Renfrew | Uxbridge | Mississauga |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 | Yavne | Be'Er Sheva | Tel Aviv |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 :
New Mexico | Ciudad de México |New Zealand :
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Auckland |Lima Region :
Lima |Cebu Province :
Cebu City |Philippines :
Manila |Mazovia :
Warsaw |Remote :
Slovakia | Remote - Middle East | McFarland | Tulsa | Leinster | Melbourne | Victoria | Lousiana | Hungary | Faridabad | Belgium | Bountiful | Medan | Castlebar | Bishop | Switzerland | Green Way | Thailand | Riga | Hammond | Springville | Remote - South America (Latin Americal) | French | Zaragoza | Ireland | Remote | Remote - Africa | Remote - Europe | Xzagreb | Nairobi | Lenexa | Remote, USA | Manipal | Blue Bell | Minnesota | Texas |Bucharest :
Bucharest |Makkah :
King Abdullah Economic City | Najran | Rabigh | Khulais | Jeddah | Riyadh |Nišava District :
Niš |Singapore :
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Midrand | South Africa |Brazil :
Brazil | Sao paulo |South America :
Argentina | Peru |Catalonia :
Barcelona |Madrid :
Madrid |Sweden :
Sweden |Taipei :
Taipei |Williamson :
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Kyiv |Dubai :
Dubai |Hà Nội :
Hanoi | Hà Nội |Ho Chi Minh :
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