Job Title
Manager, Regulatory Affairs
Location
Seoul, Korea
About our Client
Korean CRO specializing in oncology clinical trials for the pharmaceutical and biotech industries
Key Responsibilities
Develop and implement regulatory strategies that support clinical trials and facilitate timely market authorization, which includes leveraging extensive knowledge of regulatory frameworks, guidelines, procedures, and agency precedents
Analyze scientific data and reports to create Clinical/Regulatory development plans for targeted indications, ensuring alignment with regulatory guidelines, which involves conducting gap analyses, drafting protocol synopses, organizing regulatory authority meetings, and delivering other strategic documents
Collaborate with internal teams to draft and review regulatory documents such as regulatory development plans, briefing packages, and special designation requests
Manage the preparation and submission of regulatory applications (INDs, NDAs, BLAs) to regulatory authorities (e.g., MFDS, FDA, EMA) and ensure compliance with global regulations
Represent clients in regulatory meetings, providing expert guidance and facilitating discussions with health authorities
Perform gap analyses to identify regulatory requirements and risks, providing strategic recommendations to mitigate them
Stay informed about evolving global and regional regulatory trends and requirements, ensuring that strategies are adapted accordingly
Participate in internal business development meetings, contributing to project scope definition, proposal preparation, and statement of work development
Key Requirements
Bachelor’s or master’s degree in biological sciences, pharmacy, medicine, or a related field. Advanced degrees or regulatory certifications are a plus
A minimum of 7 years of experience in Regulatory Affairs or a related role within the biotech or pharmaceutical industry, with a focus on regulatory drug development
Proven expertise in regulatory filings (INDs, NDAs, BLAs), ideally with experience in oncology drug development
Extensive knowledge of global regulatory requirements and experience with regulatory submissions to health authorities
Strong organizational and project management skills, with the ability to manage multiple projects and deadlines effectively
Excellent communication and interpersonal skills, with experience in representing clients and leading discussions with regulatory bodies
Contact
May Lwin, Permanent Associate Consultant
02 6200 9787
May.Lwin@adecco.com