Reporting to the Vice President, Regulatory Affairs, Advertising Promotion & Labeling, the Director, Regulatory Affairs, Labeling will lead and facilitate the generation of new, and revision of, core labeling documents (Target Labeling, Company Core Data Sheet, US Prescribing Information, etc), in collaboration with cross-functional subject matter experts and Global Regulatory Leads (GRLs). The position requires management of multiple assigned products, including early and late-stage assets with differing levels of complexity. This position partners with other personnel including Regulatory, Clinical Development, Drug Safety, and Quality in support of development and maintenance of labeling content and contributes to health authority negotiations as necessary.
- Acts as point of contact for cross-functional teams on local and global labeling issues. Manages labeling development or approval. Preparation of updated Core Data Sheets and US Documentation: Independently manages, prepares and implements regulatory documents (e.g., USPI, annotated labeling, medication guides). Independently leads cross functional teams through all labeling discussions with the FDA while ensuring management alignment. Strategizes and plans for FDA meetings as needed.
- Conduct Label Committee Meetings: Prepares documents for review by labeling teams and labeling committee. Leads review processes and ensures appropriate governance for review of labeling documents.
- Ensure Compliance with Labeling Regulations and Guidance: Researches applicable Health Authority labeling regulations for products and filings. Manages compliance with internal and external guidelines, with regard to both content and format of labeling. Follows internal processes for record keeping and tracking of labeling milestones.
- Establish Processes and Best Practices: Reinforces labeling best practices at cross-functional meetings. Leads the continuous improvement in process, including enhancement of Standard Operating Procedures (SOPs).
- Department Coordination: Builds cross-functional relationships.
- Leads development of the labeling strategy for multiple products and indications.
- Oversees and guides the preparation and maintenance of regulatory labeling for multiple products across therapeutic areas.
- Provides strategic advice and guidance to cross-functional partners and stakeholders.
- Oversees and guides review/approval of U.S. labeling in Structured Product Labeling (SPL) format, artwork requests, archiving labeling documents, and updating label histories.
- Develops and maintains target labeling documents for early phase products, in collaboration with GRL and product teams. Maintains an understanding of competitive landscape in assigned disease areas and opportunities for strategic differentiation.
Skills:
- High level of applied knowledge of applicable FDA laws, regulations, guidance, and industry standards.
- In depth understanding of clinical trial design and interpretation of clinical data.
- Strong interpersonal skills, strong communication skills (written and verbal).
- Ability to communicate complex issues clearly and concisely.
- Shape and develop strategies based on emerging trends.
- Ability to communicate business issues across all levels of the organization, negotiate business decisions, and work toward solutions to drive compliance.
- Significant experience leading development of regulatory labeling or related strategies, leading cross-functional regulatory activities, and representing Regulatory to cross-functional teams for multiple products.
- Proven track record in effectively setting and directing the regulatory labeling or related strategy to successful conclusion for one or more products.
- Significant experience working with a broad array of regulatory labeling documentation and processes, including core data sheets, prescribing information, and target product labels for both marketed and investigational products.
- Significant experience in NDA/BLA labeling and labeling negotiations.
- Strong track record of successes working and negotiating with regulatory authorities.
- Extensive experience participating in cross-functional projects and teams.
