Director, Regulatory Advertising and Promotion N.A.

Sobi • Waltham, MA

19d • Remote

About The Position

The Director Regulatory Advertising and Promotion N.A is responsible for providing strategic and tactical regulatory ad promo support and guidance related to product and disease state communications for assigned product(s) or therapeutic area across the product life cycle. As the internal subject matter expert on FDA regulations of prescription drug advertising and promotion, this role collaborates extensively with cross-functional teams to ensure that promotional communications are compliant and meet business objectives. The incumbent will serve as the primary liaison with the FDA’s office of prescription Drug Promotion (OPDP) and This role will report to the Global Head of Regulatory Advertising and Promotion and will have accountability for the review and approval of US promotional and non-promotional communications of assigned product(s). This experienced regulatory professional will contribute to the ongoing development of a best-in-class Regulatory Advertising and Promotion team. This role is remote based on US Eastern time with limited travel to for business-critical meetings/events.

Requirements

• 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.
• Experience in supporting product launch required, DTC broadcast ads experience highly desirable
• 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.

Nice To Haves

• Advanced scientific degree (MD, PharmD, PhD) or Juris Doctor with a minimum of 8 years related biopharma experience
• Experience in Rare Diseases, Immunology, and/or Hematology a plus

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

Benefits

• Competitive compensation for your work
• Generous time off policy
• Summer Fridays
• Opportunity to broaden your horizons by attending popular conferences
• Emphasis on work/life balance
• Collaborative and team-oriented environment
• Making a positive impact to help ultra-rare disease patients who are in need of life saving treatments
• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Director