Job Title: Regulatory Affairs Manager
Location: Flexible
Work Schedule: Standard (Mon-Fri)
Environmental Conditions: Office
Position Summary
As a Regulatory Affairs Manager, you will lead a team of regulatory professionals, providing strategic intelligence and expertise for product development from preclinical phases through registration and lifecycle management. You will be a key advisor on regulatory strategies, ensuring compliance, driving innovation, and maintaining high ethical and regulatory standards.
Key Responsibilities
Team Leadership
Oversee and manage a team, including hiring, onboarding, performance evaluation, goal setting, and professional development.
Provide technical and behavioral coaching and mentoring to team members.
Approve staff time records, expense reports, leave requests, and overtime.
Promote adherence to ethical and regulatory standards within the department.
Regulatory Expertise and Strategic Guidance
Act as a subject matter expert, providing strategic regulatory intelligence and technical guidance to internal and external stakeholders.
Develop and manage regulatory strategies to support client projects, including preclinical, clinical, and product optimization phases.
Ensure high-quality regulatory documentation and submissions, including reviewing and finalizing deliverables.
Project Management and Business Development
Identify out-of-scope activities and collaborate with relevant departments to address contract modifications.
Lead or participate in project meetings to ensure alignment on objectives and deliverables.
Collaborate with business development teams to secure new opportunities, including preparing proposals, budgets, and presentations for clients.
Oversee budgeting, forecasting, and project resource allocation.
Compliance and Innovation
Stay updated on the latest legislation, regulatory guidelines, and organizational policies to ensure compliance.
Drive process improvements and innovation within the department.
Qualifications
Education and Experience
Bachelor’s degree or equivalent in a related field.
At least 8 years of experience in regulatory affairs or a related field.
Minimum of 2 years of leadership experience managing teams.
Skills and Knowledge
Strong communication and negotiation skills in English (and local language, where applicable).
In-depth knowledge of global, regional, and national regulatory requirements for clinical trial authorization, licensing, and lifecycle management.
Expertise in regulatory specialty areas such as preclinical, clinical, CMC, or publishing.
Solid understanding of ICH guidelines and other global regulatory standards.
Proficiency in project budgeting, forecasting, and data analysis with attention to detail.
Effective leadership skills to mentor staff, delegate tasks, and manage priorities.
Advanced computer skills, including MS Word, MS Excel, and Adobe Acrobat.
Why Join Us?
By joining our team, you will have the opportunity to shape the future of regulatory affairs in a dynamic and collaborative environment. Leverage your expertise to lead innovative projects, contribute to groundbreaking developments, and foster growth in a supportive, compliance-driven workplace.
If you’re a motivated professional eager to make an impact in regulatory affairs, apply today!
Gujarat :
Ahmedabad | Ankleshwar | Baroda | Bharuch | Gandhinagar | Gujarat | Halol | Jhagadia | Mehsana | Tarasadi | Vadodara | Vapi |Maharashtra :
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Bangalore | Belgaum | Bengaluru | B.G Nagara | Bommasandra | Colorado | Czech Republic | Karnataka | Mangaluru | Mysore | Udupi |Punjab :
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Bhubaneswar | Rourkela |Chhattisgarh :
Bilaspur | Eot Municipality | Raipur |Uttarakhand :
Dehradun | Halifax | Nainital | Rishikesh | Roorkee |Delhi :
Delhi | India | New Delhi | PAN-India |Assam :
Dibrugarh | Diburghar | Guwahati |West Bengal :
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Hajipur | Patna |Kerala :
Kannur | Kochi | Malappuram | Thiruvananthapuram | Trivandrum |Pondicherry (Puducherry) :
Pondicherry (Puducherry) |Jharkhand :
Ranchi |Sikkim :
Rangpo |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 | Georgia | Keene | Michigan | Mt. Pleasant | New Jersy | OH | Piedmont | Salisbury | United States | Whitesboro | Winston-Salem |Georgia :
Atlanta | Augusta | Rome |Maine :
Bangor | Brewer |New Jersey :
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Concord | Lumberton | North Carolina |Michigan :
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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 :
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Hebron | Nebraska City |Hawaii :
Hilo | Honolulu |Tennessee :
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Lake Charles | Shreveport |Nevada :
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Mexico |northeastern :
New Hampshire |Oklahoma :
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Washington |Delaware :
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Berlin |Baden-Wurttemberg :
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Germany | GErmany |Lower Saxony :
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Kiel |Berlin :
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 :
Finland |Istanbul :
Istanbul | Turkey |Norway :
Norway | NOrway |Romania :
Romania |Belgium :
Wavre |Tipperary :
Ballydine |Cork :
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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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 :
Renfrew | Australia | North York | Uxbridge | Richmond Hill | Mississauga |Canada :
Canada |Quebec :
Montreal |Brussels :
Brussels |Antwerp :
Heist op den Berg |Flemish Brabant :
Zaventem |South America :
Peru | Argentina |Brazil :
Brazil | Sao paulo |Attica :
Koropi | Athens |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 :
Estonia | Tartu |Harju County (Maakond) :
Tallinn |Hà Nội :
Hà Nội | Hanoi |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 :
Netanya | Yavne | Be'Er Sheva | Kfar Saba | Tel Aviv |Remote :
Manipal | Lenexa | Remote, USA | Melbourne | Medan | Remote - Middle East | Xzagreb | Remote | Nairobi | Belgium | Thailand | French | Minnesota | Hammond | Zaragoza | Bishop | Victoria | Tulsa | Texas | Ireland | Regulatory Labeling Manager (NA and LATAM Only) | Remote - South America (Latin Americal) | Remote - Europe | Green Way | Slovakia | Remote - Africa | McFarland | Riga | Switzerland | Castlebar | Faridabad | Lousiana | Bountiful | Leinster | Blue Bell | Springville | Hungary |Republic of Colombia :
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Brentwood |Bucharest :
Bucharest |Buenos Aires :
Buenos Aires |Republic of Egypt :
Cairo |Mexico :
New Mexico | Ciudad de México |Dubai :
Dubai |Makkah :
Rabigh | Najran | King Abdullah Economic City | Jeddah | Riyadh | 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 :
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Sweden |Taipei :
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