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Associate Director, US Regulatory Affairs Strategy

1 month ago

Raleigh, United States Meet Recruitment Full time

Position Summary:

The client is seeking a seasoned professional to lead their regulatory strategy for a late-phase oncology program. This role offers the chance to shape the future of oncology treatments within a company that values innovation and strategic thinking.

Key Responsibilities:

Support the lead regulatory strategy for late-phase oncology programs, ensuring alignment with global regulatory requirements.

Demonstrate strong regulatory knowledge and expertise, particularly in oncology and other therapeutic areas.

Ability to work independently and collaboratively with cross-functional teams.

Effective communication skills and cultural fit within the organization.

Candidate Requirements:

Minimum of 8 years of industry experience, with at least 4 years in regulatory affairs.

Strong technical proficiency in regulatory affairs is crucial.

Experience in oncology is highly preferred but not necessarily at the Director level.

Previous experience in mid to large-sized pharmaceutical sponsors; experience in smaller environments or CROs will not suffice.

Excellent communication skills and ability to fit into the organizational culture.

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