For The Candidates

Senior Director, Regulatory Affairs Oncology

Department Name

Regulatory Affairs

Location/Territory Name

Job Description

Develop and guide the regulatory strategy for the approval of assigned Oncology products.

Aid and supervise the preparation of regulatory submissions in the US, Canada, and Latin America.

Serve as the Regulatory International Product Team member for Oncology and provide regulatory leadership.

Monitor Oncology programs so they comply with the required Health Authority Regulations and Laws.

Interact with Health Authorities to address regulatory issues and to maintain the product development plan on schedule.

Coordinate regulatory project activities with global counterparts.

Job Qualifications

Doctorate degree highly desired (e.g., MD, JD, Pharm D, or PhD in life sciences), advanced degree preferred (e.g., RPh)

Senior Director: Minimum 10-12 years of regulatory experience plus 2-3 years of additional related experience (i.e., clinical development, medical writing, medical affairs).

Must have experience in the development of Biologics and BLA submissions for Biologics

Must have experience in interacting with the appropriate regulatory bodies and in Oncology Drug Development.

Must possess in-depth knowledge of appropriate Code of Federal Regulations, Regulatory Guidance Documents and ICH Regulations.

Experience with electronic submissions highly desirable and having completed filings (i.e., NDA’s, BLA’s, IND’s) to health authorities.

History of working in complex team environments with numerous/diverse stakeholders.

Incumbent must have demonstrable leadership skills, be politically savvy, and able to handle sensitive relationships between regulatory CFU and the PCU. Incumbent should also possess good listening, influencing and negotiation skills, and be able to work as a team player across cultures.