Turning Point is looking for a Senior Director, Regulatory Advertising and Promotion to join its growing team.
Turning Point Therapeutics is a clinical-stage precision oncology company with a pipeline of internally discovered investigational drugs designed to address key limitations of existing cancer therapies. The company’s lead program, Repotrectinib, is a next-generation kinase inhibitor targeting genetic drivers of non-small cell lung cancer and advanced solid tumors. Turning Point Therapeutics is driven to develop therapies that mark a turning point for patients in their cancer treatment.
The Senior Director of Ad Promo will be responsible for development and implementation of global regulatory labeling strategies for all Turning Point Therapeutics products. Through cross-functional collaboration, they will lead and provide tactical guidance to program teams, prepare Target Product Labels, lead label negotiations with Health Authorities, and prepare US Prescribing Information (USPI) and EU Summary of Product Characteristics (SmPC).
This is a leadership position within Regulatory Affairs and on product teams that requires comprehensive understanding of strategic global labeling and significant interactions with Commercial, Medical and Legal leading to product launch.
- Lead the development of product labeling from early development (target product profiles and labeling) through life-cycle management
- Manage complex labeling projects, including the development, review, and approval of the Company Core Data Sheet (CCDS), USPI and European SmPC, as well as acting as a subject matter expert to provide strategic labeling advice for other regional labels
- Provide strong strategic guidance on Global labeling regulations, requirements, competitor labeling, and labeling trends
- Prepare SPL (Structure Product Labeling) for inclusion in US Labeling and Drug Establishment Registration and Listings
- Manage labeling negotiations with FDA and EMA; draft responses to Health Authority queries and revised labeling for submissions; track labeling-related Health Authority requests and responses
- Create and maintain labeling procedures and processes
- Provide strategic and tactical labeling advice and guidance to teams and leadership
- Act as the scientific resource to the Promotional Review Committee (PRC) and Medical Review Committee (MRC)
- Provide regulatory guidance according to the assessment of approved product labeling, references, applicable regulations, and regulatory environment materials (i.e., enforcement actions, advisory comments, and guidance documents for the pharmaceutical industry, etc.)
- Serve as an internal expert on global regulations (FDA, EMA, PMDA), guidance, and enforcement trends governing the promotion of prescription drugs
- Ensure compliance with applicable laws, regulations, and Health Authority guidelines, as well as internal audit document requirements
- Remain current in related regulations and new regulations to ensure systems, processes, and procedures accurately reflect current global standards
- Bachelor’s Degree required; advanced degree in health-related field (Pharm D, PhD, or equivalent) preferred
- At least 10 years of biopharmaceutical and/or agency/medical education company experience
- Proven ability to lead and influence others and to collaborate effectively with peers, within global teams and in communicating with senior leadership
- Demonstrated experience in leading the development and life-cycle management of global labeling, from Target Labeling Profiles to the Company Core Data Sheet
- Comprehensive knowledge of labeling regulations and guidance governing drug development and maintenance in major markets (US, EU, Japan)
- Clear and effective verbal and written communication skills, and articulate and persuasive project management and presentation skills
- Pro-active, energetic, self-assured professional with high personal integrity and ability to develop good interpersonal relationships
- Experience working on cross-functional teams and within a review committee
- Ability to implement and manage multiple projects simultaneously, with high attention to detail