Sobi - Swedish Orphan Biovitrum AB (publ)

Compliance

• The Senior Manager, Regulatory Advertising and Promotion, N.A. will be responsible for ensuring that product and disease communications comply with applicable laws, regulations, Sobi policies, and regulatory requirements for both promotional and non-promotional materials related to assigned product(s).
• Reporting to the Global Head of Regulatory Advertising and Promotion, this role will serve as the primary regulatory reviewer on the Sobi Review Committee(s) for promotional and non-promotional materials.
• The incumbent will provide strategic regulatory guidance based on a strong understanding and sound interpretation of FDA regulations, guidance documents, OPDP/APLB precedents, and industry best practices.
• This position requires frequent interaction and strong collaboration with cross-functional partners, including Legal, Medical, Compliance, Marketing, Labeling, and other teams, to develop strategies and implement tactics for compliant communications that align with Sobi’s corporate and brand objectives.
• This is a remote role with occasional travel to Sobi sites for business-critical meetings and events.