Regulatory Submissions Manager
Location: Bangalore, India (Remote)
Job Type: Full-Time
Job Requisition ID: JR147403
About ICON
ICON is a global healthcare intelligence and clinical research organization dedicated to accelerating the development and delivery of innovative medicines and treatments to patients worldwide.
Guided by our core values of Integrity, Collaboration, Agility, and Inclusion, we foster a culture of excellence, innovation, and professional growth while supporting the advancement of healthcare globally.
Position Overview
We are seeking an experienced Regulatory Submissions Manager to join our Regulatory Affairs team. In this role, you will lead and manage global regulatory submission activities, provide strategic regulatory guidance, and support drug development programs across various stages of the product lifecycle.
The successful candidate will possess strong expertise in regulatory submissions, health authority interactions, and global regulatory requirements, with demonstrated experience managing Clinical Trial Applications (CTA), Investigational New Drug Applications (IND), Marketing Authorization Applications (MAA), and other regulatory filings.
Key Responsibilities
Regulatory Submission Management
Lead the planning, preparation, review, and submission of regulatory dossiers.
Manage regulatory submissions across various stages of product development and commercialization.
Ensure submissions meet global regulatory requirements, timelines, and quality standards.
Coordinate submission activities with internal stakeholders and external partners.
Regulatory Strategy & Guidance
Provide regulatory expertise and strategic guidance to cross-functional project teams.
Interpret and communicate evolving regulatory requirements and guidelines.
Support regulatory planning throughout the product development lifecycle.
Contribute to regulatory risk assessment and mitigation strategies.
Health Authority Interactions
Participate in communications and interactions with global regulatory agencies.
Support preparation of briefing documents, responses, and submission packages.
Assist in addressing regulatory queries and information requests.
Facilitate effective communication between project teams and regulatory authorities.
Clinical Development Support
Provide regulatory support for:
Clinical Trial Applications (CTA)
Investigational New Drug Applications (IND)
Marketing Authorization Applications (MAA)
Regulatory Amendments
Lifecycle Maintenance Activities
Post-Approval Regulatory Submissions
Ensure compliance with applicable regional and international regulations.
Cross-Functional Collaboration
Collaborate with:
Clinical Development Teams
Regulatory Affairs Teams
Medical Writing
Clinical Operations
Pharmacovigilance
Quality Assurance
Project Management
Support integrated regulatory planning and execution across programs.
Process Improvement & Best Practices
Contribute to the development and implementation of regulatory best practices.
Share regulatory insights, lessons learned, and industry trends with internal teams.
Support continuous improvement initiatives within the Regulatory Affairs function.
Promote operational excellence and compliance across projects.
Leadership & Project Oversight
Lead regulatory activities independently across assigned projects.
Coordinate and prioritize multiple regulatory deliverables simultaneously.
Provide guidance and mentorship to junior regulatory professionals when required.
Ensure timely completion of project milestones and regulatory commitments.
Required Qualifications
Education
Bachelor’s Degree in:
Life Sciences
Pharmacy
Biotechnology
Healthcare Sciences
Related Scientific Discipline
Preferred
Master's Degree, PharmD, MSc, MBA, or other advanced scientific/healthcare qualification.
Experience
Required
Minimum 6 years of Regulatory Affairs experience within:
Pharmaceutical Industry
Biotechnology Industry
Clinical Research Organizations (CROs)
Demonstrated experience managing regulatory submissions independently.
Essential Experience
Clinical Trial Applications (CTA)
Investigational New Drug Applications (IND)
Marketing Authorization Applications (MAA)
Regulatory Submission Planning and Execution
Global Regulatory Compliance
Uttar Pradesh :
Agra | Gajraula | Gautam buddha Nagar | Ghaziabad | Gorakhpur | Greater Noida | Jhansi | kanpur | Lucknow | Mathura | Noida | Park City | Prayagraj | Satyamev | Varanasi |Gujarat :
Ahmedabad | Ankleshwar | Baroda | Bharuch | Gandhinagar | Gujarat | Halol | Jhagadia | Mehsana | surat | Tarasadi | Vadodara | Vapi |Maharashtra :
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Dehradun | Halifax | Nainital | Rishikesh | Roorkee |Delhi :
Delhi | Gangtok | New Delhi | PAN-India |Assam :
Dibrugarh | Diburghar | Guwahati |West Bengal :
Digha | Kolkata | Mukundapur |Goa :
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 :
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Big Piney | Cokeville |Alabama :
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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 :
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 :
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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 :
San Juan |Albama :
Tuscaloosa |D.C :
Washington |Delaware :
Wilmington |North Rhine Westphalia :
Aachen | Bielefeld | Bochum | Bonn | Cologne | Dortmund | Duisburg | Dusseldorf | Munster |Munich :
Bavaria |Bavaria :
Bayreuth | Erlangen | Munich | Regensburg | Wurzburg |Brandenburg :
Berlin |Baden-Wurttemberg :
Biberach an der Riß | Freiburg | Grenzach | Heidelberg | Karlsruhe | Konstanz | Stuttgart | Tubingen | Ulm |Hesse :
Darmstadt | Marburg |Hessen :
Frankfurt | Harveysburg |Germany :
Germany | GErmany |Lower Saxony :
Gottingen | Hannover | Leipzig |Saxony Anhalt :
Halle |Rotherbaum :
Hamburg |Rhineland Palatinate :
Ingelheim am Rhein | Mainz |Schleswig Holstein :
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 :
Breda |Noord Holland :
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 :
Renfrew | Uxbridge | Mississauga | North York | Australia | Richmond Hill |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 :
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 :
Saitama | Japan |Tokyo :
Otemachi |North Ostrobothnia :
Oulu |Southwest Finland (Varsinais-Suomi) :
Turku |Remote Korea :
Remote Korea |Republic of Korea :
Seoul |Kazakhstan :
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Bangkok |Israel :
Tel Aviv | Kfar Saba | Yavne | Netanya | Be'Er Sheva |Remote :
Milwaukee | Tulsa | Bishop | Remote - Africa | Texas | Lousiana | Perth | Medan | Slovakia | Victoria | Regulatory Labeling Manager (NA and LATAM Only) | Hammond | Switzerland | Remote - Europe | Castlebar | Zaragoza | Green Way | Thailand | Melbourne | French | Springville | Bountiful | Ireland | Riga | Remote - Middle East | Leinster | Xzagreb | McFarland | Blue Bell | Faridabad | Hungary | Remote - South America (Latin Americal) | Belgium | Nairobi | Minnesota | Manipal | Lenexa |Republic of Colombia :
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New Mexico | Ciudad de México |Dubai :
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Najran | Khulais | Riyadh | Rabigh | King Abdullah Economic City | Jeddah |Kuala Lumpur :
Kuala Lumpur |Kyiv Oblast :
Kyiv |Lima Region :
Lima |France :
Paris | Lyon |South Africa :
Midrand | South Africa |Nišava District :
Niš |Bohemia :
Prague |Chile :
Santiago |Bosnia and Herzegovina :
Sarajevo |Singapore :
Singapore |Sofia City :
Sofia |Sweden :
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Taipei |Mazovia :
Warsaw |
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