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Senior Manager, Regulatory Affairs at ICON plc - ApplyBlast

Senior Manager, Regulatory Affairs

ICON plc

4 months ago

India

Hybrid

Full Time

Senior

0 applicants

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About this role

The Senior Manager in Regulatory Affairs leads CMC strategy for biologics and cell/gene therapies, providing expert guidance on global drug development and regulatory submissions. This role involves managing technical documentation, leading client negotiations with government agencies, and developing innovative regulatory strategies to ensure product approvals. Based in Chennai, Bangalore, Trivandrum, or remotely, the position requires extensive experience in pharmaceutical regulation and cross-functional collaboration.

Responsibilities

Develop and execute CMC strategies for biologics and cell/gene therapies
Lead preparation of regulatory submission documents for global markets
Facilitate approvals through negotiations with government agencies and clients
Monitor emerging regulatory requirements and advise stakeholders proactively
Manage cross-functional projects within budget while ensuring compliance

Skills

Qualifications

Bachelor’s degree in Life SciencesPharmacist License (Degree)RhAPE Certification (Regulatory Affairs)US Pharmacist LicenseMSc or PhD in Biological Sciences

About ICON plc

iconplc.com

Headquarters

South Dublin, Ireland

Company Size

10001+ employees

Founded

1990

View Profile

ICON plc is a global clinical research organisation (CRO) that provides outsourced clinical development and commercialisation services to pharmaceutical, biotechnology and medical device companies. It offers end-to-end drug and device development support — including clinical trial management across phases, data management and biostatistics, regulatory and safety/pharmacovigilance, and commercialisation and market-access services. ICON combines scientific and therapeutic expertise with technology and a scalable global operations network to accelerate development and bring therapies to patients. Clients engage ICON for integrated, experienced CRO support across the full product lifecycle.