Job Title
Senior Regulatory Affairs Consultant
Location
USA (Remote work possible)
Employment Type
Permanent Contract
Department
Product Development – Regulatory Affairs & Operations
Company
ProductLife Group
Role Overview
The Senior Regulatory Affairs Consultant is a client-facing regulatory strategy and execution leader responsible for guiding pharmaceutical and biotechnology programs through U.S. FDA regulatory pathways, primarily during pre-market development stages.
The role acts as a strategic advisor, regulatory lead, and program manager across complex, multi-disciplinary drug and biologics programs.
Key Responsibilities
1. Regulatory Strategy & Leadership
Lead regulatory strategy for biotech and pharma development programs
Develop integrated regulatory and development plans
Provide both strategic and tactical regulatory guidance across product lifecycle stages
Serve as primary regulatory advisor for client engagements
2. FDA & Health Authority Interactions
Lead preparation of:
IND submissions
NDA and BLA submissions
Amendments and regulatory updates
Health Authority meeting packages
Represent clients in FDA interactions
Act as Authorized Sponsor Representative
Prepare and coach clients for regulatory meetings
3. Cross-Functional Program Leadership
Lead Clinical, CMC, and Nonclinical teams across projects
Manage multi-indication and multi-product programs
Ensure alignment across development functions
Provide regulatory input into development planning
4. Project & Program Management
Define project scope, timelines, and resource plans
Monitor risks and implement mitigation strategies
Track program progress and deliverables
Communicate regulatory status to internal and external stakeholders
5. Regulatory Documentation & Submissions
Author and review:
INDs
NDAs
BLAs
Amendments
Meeting packages
Ensure compliance with FDA and global regulatory standards
6. Consulting & Business Development
Support proposal development and Statements of Work (SOWs)
Contribute to new consulting offerings and service expansion
Participate in publications, conferences, and workshops
Provide regulatory intelligence and precedent-based recommendations
7. Mentorship & Internal Leadership
Mentor junior regulatory professionals
Support matrixed project teams
Contribute to internal training and capability development
Required Qualifications
Education
Bachelor’s degree in a scientific discipline:
Life Sciences
Pharmacy
Biology
Chemistry
Or related field
Experience
10–15 years in Regulatory Affairs
Strong hands-on experience with U.S. FDA regulatory systems
Experience across full development lifecycle (early to registration stage)
Proven leadership in regulatory strategy and execution
Core Expertise Required
Regulatory Knowledge
FDA regulations and guidance
ICH guidelines
Global regulatory frameworks
Regulatory intelligence and precedent-based decision-making
Leadership & Execution Skills
Cross-functional leadership (Clinical, CMC, Nonclinical)
Program and project management expertise
Ownership of timelines and deliverables
Strong client-facing communication skills
Experience in high-complexity regulatory programs
Compensation
USD $170,000 – $210,000 per year
Based on experience, skills, and internal equity
Core Function
This role provides high-level regulatory strategy leadership and execution support for U.S. FDA submissions and biotech/pharma development programs in a consulting environment.
Uttar Pradesh :
Agra | Gajraula | Gautam buddha Nagar | Ghaziabad | Gorakhpur | Greater Noida | Jhansi | kanpur | Lucknow | Mathura | Noida | Park City | Prayagraj | Satyamev | Varanasi |Gujarat :
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Delhi | Gangtok | New Delhi | PAN-India |Assam :
Dibrugarh | Diburghar | Guwahati |West Bengal :
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Goa | Panaji | Verna |Bihar :
Hajipur | Patna |Kerala :
Kannur | Kochi | Malappuram | Thiruvananthapuram | Trivandrum |Pondicherry (Puducherry) :
Pondicherry (Puducherry) |Jharkhand :
Ranchi |Sikkim :
Rangpo |India :
Remote, India | 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 | Geelong Vic | Georgia | Keene | Michigan | Mt. Pleasant | New Jersy | OH | Piedmont | Salisbury | 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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Baton Rouge | Monroe | New Orleans |Washington :
Bellevue | Bothell | Friday Harbor | Goldendale | Mount Vernon | Pullman | Seattle | Sherwood | Tacoma | Vancouver |Oregon :
Bend | Coquille | Corvallis | Eugene | Florence | Grants Pass | John Day | Lake Oswego | Lakeview | Portland | Reedsport | Roseburg | Salem | Springfield | Woodburn |Wyoming :
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 :
Boise |Colorado :
Boulder | Denver | Westminster |Connecticut :
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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 :
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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 :
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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 :
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Mitte |Mecklenburg Vorpommern :
Rostock |Saarland :
Saarbrucken |Switzerland :
Basel | Zurich |Serbia :
Belgrade | Serbia |Hungary :
Budapest |BULGARIA :
Bulgaria | Vedant |Denmark :
Copenhagen | Denmark |Europe :
Europe | France | Latvia | Lendava | Leuven | Poland | Slovenia | Spain |Finland :
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Istanbul | Turkey |Norway :
Norway | NOrway |Romania :
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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 :
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China | Quarry Bay |Liaoning :
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Hangzhou |Tokiyo :
Osaka | Tokyo |Shanghai Sai :
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Netherlands |Remote Australia :
Arkansas | Remote Australia |New South Wales :
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South Yarra |United Kingdom :
England | Harlow | Leeds | London | Maidenhead | Salt Lake City | Stevenage | Stirling | United Kingdom |North Yorkshire :
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Sheffield |Oxfordshire :
Witney |Ontario :
Richmond Hill | Australia | North York | Renfrew | Uxbridge | Mississauga |Canada :
Canada |Quebec :
Montreal |Brussels :
Brussels |Antwerp :
Heist op den Berg |Flemish Brabant :
Zaventem |South America :
Peru | Argentina |Brazil :
Brazil | Sao paulo |Attica :
Athens | Koropi |Greece :
Greece |North Island :
Auckland |New Zealand :
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Austria |Vienna :
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Barcelona |Madrid :
Madrid |Cebu Province :
Cebu City |Philippines :
Manila |Croatia :
Croatia |Zagreb :
Zagreb |Estonia :
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Tallinn |Hà Nội :
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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 :
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Bangkok |Israel :
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Kyiv |Lima Region :
Lima |France :
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Midrand | South Africa |Nišava District :
Niš |Bohemia :
Prague |Chile :
Santiago |Bosnia and Herzegovina :
Sarajevo |Singapore :
Singapore |Sofia City :
Sofia |Sweden :
Sweden |Taipei :
Taipei |Mazovia :
Warsaw |
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