Director, Regulatory Affairs for Advertising Promotion
Type: Full Time
Salary: 162,500.00 - 223,500.00
4 Year Degree
Internal Number: 266
The Director, Regulatory Affairs for Advertising Promotion is responsible for providing commercial regulatory strategy and leadership to enable the US business to meet its commercial needs in a compliant manner. Responsibilities pertain primarily to US marketing activities. The Director can be remote and will report to the Executive Director, Regulatory Affairs for Advertising Promotion. The Director will review promotional, corporate and other non-promotional materials to assess for compliance with the applicable regulations, guidance documents, and internal policies/best practices. This position must be capable of representing the commercial regulatory perspective at and chairing the Medical, Legal, Regulatory (MLR) review committee which includes cross functional partners from Marketing, Medical Affairs, and Legal. The Director will be required to assume a leadership role in advising cross-functional stakeholders on the commercial regulatory impact of new campaign concepts and product labeling and may also be required to provide strategic regulatory guidance on corporate communications and appropriate pre-approval communications. The Director will also serve as a liaison to the FDA’s Office of Prescription Drug Promotion for respective product(s) and will help ensure materials are submitted to FDA in a timely manner.
Review and approve promotional, corporate and other non-promotional materials for relevant products and associated therapeutic areas
Represent the commercial regulatory perspective and rationale at regulatory project team meetings, labeling meetings, brand team meetings and, as needed, providing training to cross-functional colleagues including members of the MLR
Review and interpret enforcement letters, keeping current with industry changes relating to advertising and promotion, interpreting new Guidances to Industry, and, as applicable, evaluating related internal policies/best practices and processes.
Provide strategic regulatory guidance on corporate communications and appropriate pre-approval communications.
Serve as a liaison to the FDA’s Office of Prescription Drug Promotion for respective product(s) and will help ensure materials are submitted to FDA in a timely manner.
Assist with development of prescription drug labeling
9 years’ experience in Regulatory Affairs Ad/Promo within pharmaceutical and/or biotechnology industry
Oncology, rare disease, and/or other relevant therapeutic area experience is desirable.
Excellent verbal and written communication skills and interpersonal skills are required.
Must be capable of developing and implementing commercial regulatory strategy and managing complex negotiations with internal and external stakeholders.
The position will be recognized as a knowledgeable resource for commercial regulatory
Direct experience working with FDA’s Office of Prescription Drug Promotion or Advertising and Promotional Labeling Branch is preferred.
Strong leadership skills and ability to lead cross functional teams and advise Company stakeholders on changes in regulations, policies, and enforcement which may impact the Company’s promotional activities.
Outstanding communication skills and excellent ability to engage, influence and navigate senior stakeholders.
Ability to effectively collaborate, including remotely, in a fast-paced dynamic environment.
This position must be able to work East Coast hours.
SpringWorks Therapeutics is a clinical-stage biopharmaceutical company applying a precision medicine approach to acquiring, developing, and commercializing life-changing medicines for underserved patient populations suffering from devastating rare diseases and cancer. SpringWorks has a differentiated portfolio of small molecule targeted oncology product candidates and is advancing two potentially registrational clinical trials in rare tumor types, as well as several other programs addressing highly prevalent, genetically defined cancers. SpringWorks’ strategic approach and operational excellence in clinical development have enabled it to rapidly advance its two lead product candidates into late-stage clinical trials while simultaneously entering into multiple shared-value partnerships with industry leaders to expand its portfolio.