Job Details

• Independently leads Labeling multi-disciplinary team (Labeling Working Group – LWG) driving cross-functional collaboration to gain alignment on labeling strategy and labeling content.
• Coordinates the process to obtain labeling approval by Executive Labeling Board (ELB), as applicable to the review and approval process.
• Authors new/revised TPL, CCDS, and USPI for assigned products, obtaining input and approval from all relevant functional areas with appropriate annotations/supporting documents.
• Develops and executes a global labeling implementation plans to incorporate new scientific, safety and clinical data, as well as Health Authority responses into CCDS/USPI enabling the most current information and in compliance with labeling requirements Health Care Providers and patients.
• Independently authors and manages communications regarding CCDS and labeling updates for assigned products.
• Demonstrates strong project management skills to coordinate global labeling functions to ensure timely Health Authority submission and key role in label negotiations with Health Authorities.
• Interprets regulations and guidance documents relevant to the development and implementation of labeling documents and assures labeling content and processes conform to regulatory requirements.
• Manages process for alignment of local labeling with CCDS for assigned products, including assessment of labeling deviations in US, EU, and ROW.
• Provides strategic direction and subject-matter guidance to Local Labeling Leads for responses to health authorities’ requests/labeling negotiations.
• Appropriately presents issues and seeks endorsement from Executive Labeling Board for proposed risk mitigation strategies, labeling negotiations strategies, and other important/major labeling updates for assigned products.
• Conducts precedent, analyzes relevant competitor labeling, assesses labeling guidance and trends, and develops labeling strategies and language for assigned product labels (TPL, CCDS, USPI) to ensure consistency with the overall product strategy, product claims and information in the CCDS and to ensure the most competitive labeling possible.
• Represents Global Labeling at Regulatory Satellite, Regulatory Product Strategy, business partner meetings, and other initiatives. 
• Provides regulatory input for the development and revision of carton and container artwork. Collaborate with Technical Operations to implement approved labeling into packaging.
• Supports Health Authority Inspections by providing labeling information requests related to assigned products and overall labeling processes.
• Manages the Structured Product Label (SPL) process; collaborates with external vendors, ensures SPL is acceptable for submission, and confirms successful submission with Regulatory Operations.
• Lead and actively contribute to the continuous improvement of labeling processes, identifying opportunities for optimization to enhance efficiency.
• Additional duties assigned as needed.

 
Education/Experience Requirements:  

• Bachelor’s degree in a scientific discipline such as Biology, Biotechnology, Biochemistry, Pharmaceutical Sciences, Chemistry, Chemical Engineering, or related field required. Equivalent combination of education and applicable job experience may be considered
• Advanced degree (MS, PhD, PharmD, or equivalent) in related discipline preferred.
• 8+ years of relevant pharmaceutical or biotech industry experience. Including 6 years of direct labeling experience or combination of 5+ years regulatory and related experience.
• Strong knowledge of US and EU product labeling requirements, regulations, and guidelines (USPI and EU SmPC experience required).

Additional Skills/Experience:

• The ideal candidate will embody core values: Courage, Community Spirit, Patient Focus and Teamwork
• Driven, intelligent, passionate about making a difference for patients with rare diseases
• Experience in developing and revising product labeling (e.g. USPI and EU SmPC), as well as preparing product labeling for regulatory submissions in compliance with regulations with minimal supervision.
• Experience with US and regulatory requirements, guidelines, and procedures including global regulatory submissions, including INDs, IMPDs/CTAs, BLAs/NDAs, and MAAs.
• Experience as a Global Labeling Lead supporting local-label implementation and deviation management across multiple regions.
• Knowledge of scientific principles and regulatory/quality systems relevant to the drug development phases to commercial phase.
• Ability to develop target product labels (TPL).
• Knowledge of the Structured Product Label (SPL) process and submission.
• Experience in pharmaceutical packaging systems, including container label and carton.
• Excellent project management and organizational skills with the ability to manage multiple programs and competing priorities.
• Strong written and verbal communication skills with the ability to effectively influence cross-functional stakeholders and senior leadership.
• Demonstrated regulatory judgment, strategic thinking, and problem-solving capabilities.
• Ability to work independently and effectively within a matrixed, cross-functional environment.
• Ability to travel 10% domestically and internationally.
• All positions have an essential job function to be able to perform face to face work with colleagues and/or onsite in San Diego. No role is expected to be 100% remote.

Comp based one level/experience 150-195k range