Sobi - Swedish Orphan Biovitrum AB (publ)
Senior Manager Regulatory Advertising and Promotion
Sobi - Swedish Orphan Biovitrum AB (publ), Watertown, Massachusetts, us, 02472
Overview
Senior Manager Regulatory Advertising and Promotion, North America, 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 interpretation of FDA regulations, guidance documents, OPDP/APLB precedents, and industry best practices. This position requires frequent interaction and 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 Sobis corporate and brand objectives. This is a remote role with occasional travel to Sobi sites for business-critical meetings and events. Key Responsibilities
Serve as the primary regulatory reviewer for assigned product(s) on the Sobi Review Committee (SRC). Review materials, provide real-time regulatory risk assessments, and recommend mitigation strategies. Collaborate with cross-functional teamsincluding Medical, Legal, and Commercialto ensure that product and disease-state communications meet regulatory requirements. Monitor the external environment to keep product teams informed of evolving regulatory requirements related to advertising and promotion, and assess potential impacts on marketing activities. Plan and deliver training to internal stakeholders on U.S. laws, codes, and regulations related to drug advertising and promotion. Provide input into label development with consideration of promotional implications, including the evaluation of potential labeling claims. Ensure changes in product labeling are implemented into promotional materials in accordance with company procedures and regulatory requirements. Represent Regulatory Advertising and Promotion on cross-functional project teams and other relevant programs as needed. Collaborate with cross-functional teams to optimize the material review process. Qualifications
Minimum of a Bachelors degree in a scientific discipline required Advanced scientific degree (e.g., MS, PharmD, PhD, MD) preferred Minimum of 35 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 Compensation and Benefits
Base salary range for this role is $133,000$180,000. The role is eligible for short-term and long-term bonuses. Our benefits package includes a 401(k) match, tuition and wellness reimbursements, comprehensive medical/dental/vision coverage, and other rewards. All employees are expected to demonstrate behaviors aligned with Sobis core values: Care, Ambition, Urgency, Ownership, and Partnership. Why Join Us?
We are a global biopharmaceutical company focused on rare diseases, with a culture that values teamwork, patient impact, and a commitment to patients. We offer opportunities to grow and make a difference in peoples lives, supported by a competitive benefits package. #J-18808-Ljbffr
Senior Manager Regulatory Advertising and Promotion, North America, 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 interpretation of FDA regulations, guidance documents, OPDP/APLB precedents, and industry best practices. This position requires frequent interaction and 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 Sobis corporate and brand objectives. This is a remote role with occasional travel to Sobi sites for business-critical meetings and events. Key Responsibilities
Serve as the primary regulatory reviewer for assigned product(s) on the Sobi Review Committee (SRC). Review materials, provide real-time regulatory risk assessments, and recommend mitigation strategies. Collaborate with cross-functional teamsincluding Medical, Legal, and Commercialto ensure that product and disease-state communications meet regulatory requirements. Monitor the external environment to keep product teams informed of evolving regulatory requirements related to advertising and promotion, and assess potential impacts on marketing activities. Plan and deliver training to internal stakeholders on U.S. laws, codes, and regulations related to drug advertising and promotion. Provide input into label development with consideration of promotional implications, including the evaluation of potential labeling claims. Ensure changes in product labeling are implemented into promotional materials in accordance with company procedures and regulatory requirements. Represent Regulatory Advertising and Promotion on cross-functional project teams and other relevant programs as needed. Collaborate with cross-functional teams to optimize the material review process. Qualifications
Minimum of a Bachelors degree in a scientific discipline required Advanced scientific degree (e.g., MS, PharmD, PhD, MD) preferred Minimum of 35 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 Compensation and Benefits
Base salary range for this role is $133,000$180,000. The role is eligible for short-term and long-term bonuses. Our benefits package includes a 401(k) match, tuition and wellness reimbursements, comprehensive medical/dental/vision coverage, and other rewards. All employees are expected to demonstrate behaviors aligned with Sobis core values: Care, Ambition, Urgency, Ownership, and Partnership. Why Join Us?
We are a global biopharmaceutical company focused on rare diseases, with a culture that values teamwork, patient impact, and a commitment to patients. We offer opportunities to grow and make a difference in peoples lives, supported by a competitive benefits package. #J-18808-Ljbffr