Regulatory Affairs Strategy Manager (Oncology)

Role Summary

Responsible for managing and maintaining existing Investigational New Drug (IND), Clinical Trial Application (CTA), New Drug Application (NDA), and Biologics Licensing Application (BLA) submissions and preparing amendments in compliance with guidelines and regulations. Coordinates, compiles, and tracks product applications and submissions to regulatory agencies. Assists senior regulatory leaders with the development of documents to support designations and other health authority programs and requirements, health authority responses, and global regulatory planning.

Responsibilities

• Review clinical site regulatory documents to provide Regulatory approval to ship investigational product.
• Track safety reports and coordinate submissions to US INDs.
• Assist Project Team Regulatory Representative in preparing routine IND, NDA and BLA submissions and ex-US clinical trial applications, tracking submission progress, and archiving regulatory submissions and correspondence.
• Assist with developing and implementing strategies to ensure compliance with HA requirements.
• Respond to requests for information from regulatory bodies.
• Serve as liaison with FDA.
• Work collaboratively with consultants and contractors to accomplish regulatory activities and submissions.
• Contribute to department initiatives.

Qualifications

• Bachelor’s degree in related discipline and a minimum of seven years of related experience; or
• Master’s degree in related discipline and a minimum of five years of related experience; or
• PhD degree in related discipline; or
• Equivalent combination of education and experience.

Skills

• Ability to work independently and with others to contribute to plans, complete tasks, and achieve results within established timelines.
• Regulatory knowledge applicable to routine work; ability to gather, maintain, and apply it effectively.
• Clear verbal and written communication; provide timely information updates to management and colleagues.
• Strong interpersonal skills; ability to navigate differing views and reach resolution.
• Collaborative approach to achieve common objectives.
• Analytical mindset; ability to apply organizational objectives to solve problems.
• Self-management, integrity, and trust-building with colleagues.

Education

• Educational background corresponding to the qualifications above (Bachelor’s/Master’s/PhD in related discipline).

Additional Requirements

• Travel approximately 10%.