Regulatory Submissions Manager (Manager, Regulatory Affairs)
Job Title: Regulatory Submissions Manager / Manager, Regulatory Affairs
Location: Bangalore, India
Work Model: Remote
Employment Type: Full-Time
Job Requisition ID: JR147403
Company: ICON plc
About ICON
ICON is a global healthcare intelligence and clinical research organization dedicated to accelerating the development and delivery of innovative medicines and therapies worldwide.
Guided by its core values of Integrity, Collaboration, Agility, and Inclusion, ICON partners with pharmaceutical, biotechnology, and medical device companies to support clinical development and regulatory success across global markets.
Position Overview
ICON is seeking an experienced Regulatory Submissions Manager (Manager, Regulatory Affairs) to join its Regulatory Affairs team. This role is responsible for leading and managing regulatory activities across the product development lifecycle, including clinical development, regulatory submissions, agency interactions, marketing applications, and post-approval regulatory support.
The successful candidate will provide strategic regulatory guidance, lead submission activities, collaborate with cross-functional teams, and ensure compliance with global regulatory requirements to support successful product development and commercialization.
Key Responsibilities
Regulatory Strategy & Leadership
Lead regulatory affairs activities across assigned development programs and projects.
Provide strategic regulatory guidance to internal stakeholders and project teams.
Support regulatory planning throughout the product lifecycle, from early development through post-marketing activities.
Identify regulatory risks and develop mitigation strategies.
Regulatory Submissions Management
Independently manage and coordinate regulatory submissions, including:
Clinical Trial Applications (CTA)
Investigational New Drug Applications (IND)
Marketing Authorization Applications (MAA)
Regulatory amendments and variations
Health authority responses
Post-approval submissions
Ensure submissions are completed accurately and within regulatory timelines.
Maintain submission quality and compliance with global regulatory standards.
Health Authority Interactions
Participate in interactions with global regulatory agencies and health authorities.
Support preparation of briefing packages, meeting requests, and agency responses.
Coordinate regulatory communications throughout product development programs.
Assist in addressing regulatory questions and information requests.
Cross-Functional Collaboration
Collaborate with:
Clinical Development
Medical Affairs
Pharmacovigilance
Quality Assurance
Biostatistics
Clinical Operations
Project Management Teams
Ensure alignment of regulatory activities with overall development objectives.
Serve as a regulatory subject matter expert for project teams.
Regulatory Compliance & Intelligence
Monitor and interpret global regulatory requirements and evolving guidelines.
Ensure development programs remain compliant with applicable regulations.
Contribute regulatory expertise to support organizational decision-making.
Stay informed of emerging regulatory trends and industry best practices.
Process Improvement & Knowledge Sharing
Contribute to the development of regulatory best practices and operational efficiencies.
Support continuous improvement initiatives within the Regulatory Affairs function.
Share regulatory expertise and guidance across teams.
Assist in mentoring and developing junior regulatory professionals when required.
Required Qualifications
Education
Bachelor’s Degree in:
Life Sciences
Pharmacy
Medicine
Biotechnology
Biomedical Sciences
Other Scientific or Healthcare-Related Discipline
Preferred
Master's Degree
PharmD
PhD
Other Advanced Scientific Qualification
Required Experience
Minimum 6 years of Regulatory Affairs experience within:
Pharmaceutical Industry
Biotechnology Industry
Contract Research Organizations (CROs)
Demonstrated experience leading regulatory activities independently.
Proven experience managing global regulatory submissions.
Experience supporting product development across multiple regulatory milestones.
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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Hajipur | Patna |Kerala :
Kannur | Kochi | Malappuram | Thiruvananthapuram | Trivandrum |Pondicherry (Puducherry) :
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Remote, India | Siliguri |Illinois :
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Frank Scottile Blvd |Missouri :
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Bayreuth | Erlangen | Munich | Regensburg | Wurzburg |Brandenburg :
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Germany | GErmany |Lower Saxony :
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Saarbrucken |Switzerland :
Basel | Zurich |Serbia :
Belgrade | Serbia |Hungary :
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Bulgaria | Vedant |Denmark :
Copenhagen | Denmark |Europe :
Europe | France | Latvia | Lendava | Leuven | Poland | Slovenia | Spain |Finland :
Finland |Istanbul :
Istanbul | Turkey |Norway :
Norway | NOrway |Romania :
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Wavre |Tipperary :
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China | Quarry Bay |Liaoning :
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Tallinn |Hà Nội :
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Japan | Saitama |Tokyo :
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South Africa | Midrand |Nišava District :
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