Senior Director, Global Regulatory Lead
Boston, MA (Remote)
Development – Global Regulatory and Access Solutions /
Fulltime SD
/ Hybrid
Company Overview
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.
Role Summary
Reporting to the Senior Vice President of Global Regulatory and Access Solutions, the successful candidate will provide expertise in translating regulatory requirements into innovative, efficient and practical strategies for development of Neuroscience candidates from IND to NDA filing and approvals.
Key Responsibilities
- Create and deliver strategic regulatory guidance and risk assessment for assigned projects. Strategies should be in alignment with global/regional positions, commercial goals and key stakeholders/partner lines
- Manage regulatory aspects of projects, including the preparation and submission of correspondence, dossiers and applications to Health Authorities
- Direct point of contact with Health Authorities to facilitate the prompt review and approval of applications, supplements and commitments
- Lead Global Regulatory Teams and Rapid Response Teams for assigned projects
- Understand and interpret the regulatory environment and communicate priorities to stakeholders
- Partners with project teams and other customer groups (eg, Brand Teams) to ensure required regulatory contributions (eg, line plans, IND, NDA) meet business needs and are provided to the project teams, to agreed time, cost and quality standards
- Ensures regulatory plans are monitored, progress/variance communicated to Senior Management and any risks (from emerging technical data, changing internal objectives or external threats) mitigated
- Ensures an aligned regulatory position is reached and communicated for all key issues for assigned projects, and that these regulatory positions supporting the business are championed and communicated
- Engages in appropriate activities in order to influence the regulatory environment through Health Authorities contacts and Trade Associations (eg, BIO) as appropriate
- Ensures business compliance and implementation of and adherence to Regulatory standards
Required Qualifications
- Minimum of 10 years of experience working in the pharmaceutical/biotechnology industry with direct experience in Regulatory Affairs; Regulatory Affairs Certification (RAC) a plus
- Experience with pharmaceutical development of NCEs in Neuroscience including successfully interaction with FDA including leading such interactions
- Demonstrated experience in the preparation and submission of INDs, CTAs, and NDAs
- Experience with Pediatric Investigation Plans (PIP), Pediatric Study Plans (PSP), and other pediatric regulatory aspects preferred
- Expert knowledge with GXP/ICH requirements and Guidance in major markets, especially US and EU
- Experience managing multiple products simultaneously at different stages of the product lifecycle
- Excellent written and verbal communication skills. Strategic thinker, planner with excellent organizational skills
- Proven ability to effectively work collaboratively in cross functional teams
Desired Qualifications
- Direct experience leading a team/asset through the NDA process for approval
- Experience with ex-US regulatory authorities desirable
- Experience with labelling negotiations and advisory committees is a plus
Education
- A Master’s degree in science within a relevant scientific discipline required; PharmD, PhD or MD and/or a business qualification (DMS, MBA) may be an advantage but not required
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.
