Sobi - Swedish Orphan Biovitrum AB (publ) · 2 weeks ago
Director, Regulatory Advertising and Promotion N.A.
Waltham, MA
Full-time
Hybrid
Director/Executive
$175K/yr - $235K/yr
8+ years expSobi is a biopharmaceutical company dedicated to developing innovative therapies for rare diseases. The Director of Regulatory Advertising and Promotion N.A. will provide strategic regulatory support for product communications and ensure compliance with FDA regulations while collaborating with cross-functional teams.
BiotechnologyGeneticsMedicalPharmaceutical
Responsibilities
Serve as lead regulatory reviewer for assigned product(s) on Sobi Review Committee (SRC) and as Regulatory Adpromo representative on relevant programs and other cross-functional teams
Review draft materials and collaborate with cross-functions including Medical, Legal and Marketing, etc to ensure that product and disease-state communications are compliant and impactful
Provide strategic direction and clearly articulate any potential risks in draft materials, along with sound rationales and anticipated likely outcomes
Partner with the business by providing alternatives to achieve business objectives
Build and maintain strategic relationships with regulatory authorities- FDA, OPDP, ABLB to support Sobi business objectives
Proactively monitor and interpret monitor FDA enforcement actions and regulatory trends; assesses impact to support successful and compliant marketing of Sobi products
Assess the impact of proposed label wording or label changes on promotional strategy and provide input for label optimization as a member of the Label Working Group
Provide direction and work collaboratively to ensure that changes in product labeling are implemented in promotional materials in accordance with company procedures and regulatory requirements
Contribute to departmental and cross-functional efforts to develop and update applicable policies, procedures, guidelines and training
Responsible for a variety of tasks requiring sound judgment and independent initiative
Develop and conducts stakeholder training on matters pertaining to prescription drug promotion
Qualification
Required
Minimum Bachelor's Degree in a scientific or healthcare-related field with minimum 10 years of related biopharma experience
Minimum of 8 years of regulatory experience in the pharmaceutical industry and a minimum of 5 years of regulatory AdPromo
Expert knowledge of FDA prescription drug regulations, policies, guidances, and enforcement trends
Ability to advise key stakeholders on complex issues pertaining to adpromo compliance
Strong leadership skills including ability to collaborate across all levels of the organization in achieving sound business decisions
Good understanding of clinical study design and statistical analyses in assessment of proposed promotional claims
Understanding of drug development and labeling
Strong interpersonal and communication skills with the ability lead with or without direct authority
Foster a culture of compliance, innovation, accountability, and continuous learning
Ability to innovate, analyze, and solve problems
Preferred
Advanced scientific degree (MD, PharmD, PhD) or Juris Doctor with a minimum of 8 years related biopharma experience
Experience in supporting product launch required, DTC broadcast ads experience highly desirable
Experience in Rare Diseases, Immunology, and/or Hematology a plus
Benefits
A competitive 401(k) match to support your financial future.
Tuition and wellness reimbursements to invest in your personal and professional growth.
A comprehensive medical, dental, and vision package to prioritize your health and well-being.
Additional recognition awards to celebrate your achievements.
Company
Sobi - Swedish Orphan Biovitrum AB (publ)
Sobi is a global biopharma company unlocking the potential of breakthrough innovations, transforming everyday life for people living with rare diseases.
1001-5000 employees
Funding
Current Stage
Public CompanyTotal Funding
$825.99M2024-05-08Post Ipo Debt· $274.92M
2023-08-22Post Ipo Equity· $551.07M
2006-09-15IPO
Leadership Team
Guido Oelkers
Chief Executive Officer
Recent News
PR Newswire
2026-01-16
News Powered by Cision
2026-01-16
Company data provided by crunchbase