Director, Regulatory Affairs Strategy

Our client, a Reputable, Global Pharmaceutical Company, is seeking a Regulatory Affairs Strategy professional at the Director level. This role will advise, develop and implement regulatory strategies for specific assets within Oncology. The position will report directly into the VP of Regulatory Affairs. The company is growing exponentially with a focus in drug development within the oncology space; this hire is purely due to growth.

This role is ideally a hybrid position with the candidate living locally to New Jersey, but could be fully remote with travel.

Responsibilities:

Individual contributor role with potential management responsibilities in the future

Develop and implement Regulatory Affairs strategy for Oncology programs

Develop briefing books and act as main point of contact for FDA interactions.

Provide regulatory strategic direction for North America.

Qualifications:

8+ years of Regulatory Affairs Strategy experience

Oncology experience required

Must have led on submissions and been point of contact for FDA

Developed US strategy and led implementation

Bachelor’s degree required, advanced degree preferred