The Head, Regulatory Labeling & Promotion will be responsible for development and implementation of global regulatory labeling strategies for all Arena 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).
Additionally, this role will direct and conduct the regulatory affairs aspects of review and approval of medical and commercial material supporting external scientific communications for all products in the Arena portfolio and pipeline. 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.
What you'll dive into
- 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
- Support the development and implementation of strategies to facilitate review of promotional materials and activities
- Represent Regulatory Affairs during review of medical and commercial materials to support external scientific communications, ensure scientific and medical accuracy, adequacy of data and information supporting claims, and compliance with applicable laws and regulations.
- 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.
What we expect
- Bachelor’s Degree required; advanced degree in health-related field (Pharm D, PhD, or equivalent) preferred
- 10-15 years of biopharmaceutical and/or agency/medical education company experience
- 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)
- Proven ability to lead and influence others and to collaborate effectively with peers, within global teams and in communicating with senior leadership
- 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
What you’ll get
- To be a part a growing company and fantastic team passionate about developing novel drug therapies to improve people’s lives
- Opportunities to learn and contribute to creative solutions
- Competitive compensation package including long-term incentives
- Comprehensive health insurance (highly subsidized cost sharing on all medical plans)
- Generous matching 401k retirement plan
- Flexible time off policy and holidays including two company-wide shut-down periods each year
- Multi-cultural work environment
- Company celebrations