Regulatory Affairs Director – Oncology Strategy

BeOne Medicines USA, Inc.

United States

Remote

USD 176,000 - 236,000

Full time

4 days ago

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Job summary

BeOne Medicines Ltd. is seeking an experienced regulatory professional to oversee promotional and non-promotional communications for North America, reporting to the Head of Regulatory, Advertising/Promotion.

You will guide labeling strategy, collaborate with cross-functional teams including marketing, medical affairs, and legal, and ensure compliance with FDA regulations and industry codes. The role requires 10+ years in biotech/pharma, a scientific or health-related degree, and strong strategic

Qualifications

Bachelor’s degree in a scientific or health-related discipline with 10+ years in biotech/pharma.
Minimum 5 years in regulatory advertising/promo capacity.
Experience with FDA’s marketing/promo oversight is preferred.

Responsibilities

Oversee regulatory review of promotional materials to ensure compliance with labeling and regulations.
Provide guidance on healthcare regulations for development and commercialization in North America.
Lead regulatory representation on cross-functional teams for labeling, development, medical, and marketing.
Advise on relationships with healthcare professionals and regulatory authorities as needed.
Train on FDA and industry codes and standards applicable to promotional activities.