Job Description Summary: The Executive Director, Advertising and Promotions for Regulatory Affairs provides strategic advice and tactical management for the review of US advertising and promotional materials and related activities in accordance with business goals and objectives, Food and Drug Administration (FDA) regulations and guidances, Pharmaceutical Research and Manufacturers of America (PhRMA) guidelines, and company policies to enable the US business to meet its commercial needs in a compliant mannerThe incumbent leads negotiations with FDA's Office of Prescription Drug Promotion (OPDP) and Advertising and Promotional Labeling Branch (APLB) for assigned products and develops a strong and positive working relationship with OPDP/APLB reviewers. He/she applies regulatory and therapeutic area knowledge to the Brand Team's objectives and initiatives in order to develop solutions for complex US promotional issues and ensures regulatory compliance while effectively managing business risks. Collaborates with cross-functional internal departments and external resources on Regulatory Affairs related issues in creating and reviewing promotional and medical materials to ensure compliance with related corporate and regulatory requirements while meeting strategic promotional objectives including assessment of potential labeling claims.Ensures adherence to relevant regulatory requirements and company Standard Operating Procedures (SOPs) as appropriate. Liaises with international regulatory, medical and commercial teams to ensure consistent global messaging, as neededThe Executive Director may lead/oversee a team of internal FTEs and/or consultants and represent the function cross-functionally as needed.
Job Description:Responsibilities:
- Reviews and approves all advertising and promotional materials, concept reviews and pre-commercialization materials for assigned products in collaboration with the U.S. PTC CMLR Team (Commercial, Medical, Legal, and Regulatory) to ensure compliance with FDA regulations; serves as liaison with OPDP for assigned marketed products to facilitate the FDA review of advertising and promotional materials (e.g. launch materials submitted for advisory comment).
- Develops, implements, and maintains regulatory procedures for review of advertising and promotional materials for marketed products and pre-commercialization materials for products or uses prior to FDA-approval; oversees the management in the Veeva electronic system to track all copy through the approval and production process, works with process coordinators as necessary, and ensures materials are kept current and that expired materials are destroyed or are re-certified for continued use.
- Ensure that changes in product labeling are appropriately implemented and reflected in current promotions and advertising
- Maintains up-to-date information regarding initiatives by FDA and other applicable regulatory authorities related to labeling and review of advertising and promotional materials; monitors, interprets and communicates updates on new FDA guidance, the issuance of enforcement letters by OPDP and other Company or competitor product FDA correspondence to internal stakeholders; attends industry/FDA meetings on labeling and promotional review topics; provides training to internal teams.
- Supports emerging department business needs as determined by regulatory department leadership.
Qualifications:Bachelor's degree in a scientific or technical discipline; and a minimum of 10 years' experience in Regulatory Affairs Ad/Promo within pharmaceutical and/or biotechnology industry.
- Experience managing direct reports.
- Product Launch experience.
- Rare disease, Oncology and/or other relevant therapeutic area experience is desirable.
- Advanced knowledge of FDA guidelines (including subpart H and E) and regulations with an emphasis on product promotional activities with the ability to apply, current US labeling regulations and guidelines.
- Outstanding communication skills and excellent ability to engage, influence and navigate senior stakeholders
- Demonstrated, hands-on experience in leading activities necessary for promotional OPDP submissions (including pre-clearance and 2253, time of first use submissions)
- Familiarity with Veeva PromoMats and RIM
- Ability to routinely accept empowerment from senior leadership to proactively resolve issues and identify and champion opportunities toward optimal regulatory strategies and implementation.
- Ability to read, analyze and interpret scientific and technical information, as well as regulatory documents.
- Experienced in responding to inquiries or complaints from regulatory agencies.
- Ability to influence without direct authority.
- Strong interpersonal skills.
- Demonstrated ability in managing complex negotiations with internal and external stakeholders
- Ability to work independently and collaboratively, as required, in a fast-paced, matrixed, team environment consisting of internal and external team members.
- Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines.
- Excellent planning, organization and time management skills including the ability to support and prioritize multiple projects.
*Special knowledge or skills and/or licenses or certificates preferred.
- Advanced degree (PharmD, PhD).
- Project management experience.
- Labeling experience, an asset
- Working knowledge of Microsoft Office Suite; Veeva PromoMats, Veeva EDMS and archive
Travel requirements: 10 - 20 %*Expected Base Salary Range: $242,500 -$ 305,300 USD. The base salary offered will be contingent on assessment of candidate education level, background, and experience relative to the requirements of the position they are being considered for, as well as review of internal equity. In addition to base salary, PTC employees are also eligible for short- and long-term incentives. All eligible employees may also enroll in PTC's medical, dental, vision, and retirement savings plans.
EEO Statement: PTC Therapeutics is an equal opportunity employer. We welcome applications from all individuals, regardless of race, color, national origin, gender, age, physical characteristics, social origin, disability, religion, family status, pregnancy, sexual orientation, gender identity, gender expression, disability, veteran status or any unlawful criterion under applicable law. We are committed to treating all applicants fairly and avoiding discrimination.Click here to return to the careers page