Posted 8 Nov 2023, 4:30 am
Director Labeling at Cerevel Therapeutics
Cerevel Therapeutics is dedicated to unraveling the mysteries of the brain to treat neuroscience diseases. We are tackling neuroscience diseases with a differentiated approach that combines expertise in neurocircuitry with a focus on receptor selectivity. Our portfolio of pre-commercial neuroscience assets targets a broad range of central nervous system (CNS) disorders, including schizophrenia, epilepsy, Parkinson’s disease and substance use disorder.
Headquartered in the Greater Boston area, we are bold thinkers, deep experts, resilient pathfinders, and transparent partners who push the boundaries of scientific understanding to unlock breakthrough CNS therapies that have real impact on people’s lives.
Cerevel aspires to develop and nurture a culture characterized by trust, respect, courage, curiosity, and compassion, with a relentless focus on mission and results. Our patient-centricity guides our purpose, how we treat each other and what we work on every day. The successful candidate will bring their own unique thinking and approach to Cerevel while sharing our core values and convictions.
Working closely with Global Regulatory Leads (GRLs) and other internal and external stakeholders, the Director of Labeling, Regulatory will be accountable for managing the end-to-end label process for Cerevel products both in development and on market. This will include initial draft label development, managing label review and finalization process and managing post-approval labeling updates.
The Director of Labeling will also managing the internal global CDS (Core Data Sheet) Process. The Director of Labeling will partner with cross functional stakeholders, including, but not limited to, GRL, Global Drug Safety, Clinical Science, Regulatory CMC, Tech Ops and Supply Chain.\n
- Develop and maintain internal CDS and Labeling processes compliant with applicable regulatory requirements
- Define and implement a labelling review and approval process, including documentation of label history and team/management decisions
- Lead Draft Label development
- Lead internal CDS process
- Lead on market labeling including label updates
- Effectively communicate the regulatory labeling strategy, risks, mitigations and overall plans
- Build and maintain strong collaboration with stakeholders
- Maintain knowledge of current rules and regulations governing global labeling activities
- Provide strategic input on interpretation and implementation of key regional labeling regulations, guidelines, and best labeling practices, and align with global strategic labeling plan
- Extensive technical expertise in drug label and Core Data sheet processes
- At least 12 years of industry experience
- Extensive experience (at least 6-8 years) in global regulatory labelling
- Delivery of labeling for at least one major application, preferably NDA
- Strong experience with CTD format and content regulatory filings
- Experience dealing with broad range of stakeholders at all levels internal and external to the company
- Advanced degree (e.g., PharmD) preferred
- Science based BS or MS degree
Cerevel is an Equal Opportunity Employer and does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status or any other characteristic protected by applicable law.
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Source: Remote Ok