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.
Reporting to a Senior Manager in Regulatory Strategy and Registration within Global Regulatory & Access Sciences (GRAS), the successful candidate will provide expertise in translating regulatory requirements into innovative, efficient, and practical strategies for development of Neuroscience candidates. This role will also involve projects directly reporting up to Senior Director, Global Regulatory Lead (GRL) in Regulatory Strategy and Registration. The candidate will have responsibility for activities pertaining to regulatory strategy and submissions to the FDA and other Health Authorities and coordinate activities of other regulatory affairs staff or contract regulatory support in the performance of the duties outlined below.
Key Responsibilties * Support strategic regulatory guidance and risk assessment for assigned projects/products * Ensure regulatory contributions achieve strategy objectives, agreed standards, and minimize resource demands while maximizing overall project delivery time * Manage regulatory aspects of projects/products, including the preparation and submission of correspondence and applications to regulatory agencies * Assists and attends FDA and other agency meetings; may lead with oversight * Accountable for all US FDA submissions and approvals for projects within scope; may serve as primary FDA contact, and develops and maintains constructive working relationship with FDA contacts * May lead less complex multi-functional regulatory submissions and support GRLs for more complex submissions * Participate in Regulatory Sub Teams (RSTs) and other applicable sub-teams for assigned projects/products * Participate in Global Regulatory Teams (GRTs) for assigned projects/products, may lead GRTs, may represent GRT at project team meetings * Understand regulatory environment and communicate priorities to global/regional stakeholders * Ensures regulatory plans are monitored, progress/variance communicated to GRL 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 * Exercises sound judgement and communication in professional and timely manner * Ensures business compliance and implementation of and adherence to regulatory standards * May participate in departmental taskforces or initiatives
Required Qualifications * Minimum of 4 years of experience working in the pharmaceutical/biotechnology industry with direct experience in Regulatory Affairs; inclusive of 3 years of regulatory experience or combination of 2 year regulatory and/or related experience; Regulatory Affairs Certification (RAC) a plus * Preferred experience in reviewing, authoring, or managing components of regulatory submissions * Basic knowledge of drug development process and regulatory requirements, knowledge with GXP/ICH requirements and Guidance in major markets, especially US and EU * Able to interpret scientific data as it relates to regulatory requirements and strategy for assigned projects * Experience with pharmaceutical development of NCEs in Neuroscience, including interaction with US FDA, leading such interactions preferred * Experience managing multiple products simultaneously at different stages of the product lifecycle preferred * Excellent written and verbal communication skills. Strategic thinker, planner with excellent organizational skills * Proven ability to effectively work collaboratively in cross functional teams * Proficiency in MS Office Suite and Adobe
Desired Qualifications * Experience with labeling requirements is a plus
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.
No salary data published by company so we estimated salary based on similar jobs related to Senior and Senior jobs that are similar:
$40,000 — $80,000/year
Boston, MA (Remote)