Sobi - Swedish Orphan Biovitrum AB (publ)

Senior Manager, Regulatory Advertising and Promotion

Sobi - Swedish Orphan Biovitrum AB (publ)

full-time

Posted on:

Origin:  • 🇺🇸 United States • Massachusetts

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Salary

💰 $133,000 - $180,000 per year

Job Level

Senior

Tech Stack

Vault

About the role

  • 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.

Requirements

  • Minimum of a Bachelor's degree in a scientific discipline; advanced degree preferred.
  • Minimum of 3–5 years of experience in the pharmaceutical industry, including at least 2 years in Regulatory Advertising and Promotion.
  • Expert knowledge of U.S. advertising and promotion regulations and FDA guidance documents.
  • Direct experience supporting promotional review of product communications and engaging with FDA (OPDP or APLB) on advertising and promotion matters.
  • Experience in rare diseases, hematology, and/or immunology is a plus.
  • Proficiency with Veeva Vault PromoMats.
  • General understanding of clinical study design and statistical analysis as it relates to promotional claims.
  • Familiarity with the drug development process and drug labeling.
  • Strong interpersonal and communication skills, with the ability to lead and influence without direct authority.
  • Ability to creatively analyze complex issues and develop practical, compliant solutions.