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 a Senior Director, Global Regulatory Leader (GRL) within Global Regulatory Sciences (GRS), the successful candidate will provide expertise in translating regulatory requirements into innovative, efficient, and practical strategies for development of Neuroscience candidates.

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 Responsibilities

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

Education

Bachelor’s degree essential, scientific degree preferred. Master’s degree in science within a relevant scientific discipline, Pharm. D, Ph.D. or MD and/or a business qualification (DMS, MBA) may be an advantage but not essential

Company COVID-19 Vaccination Policy

The Company requires all employees to be vaccinated against COVID-19, including to have received a booster dose of a COVID-19 vaccine if eligible to receive one. In connection with your onboarding process, all new employees will need to provide documentary evidence of vaccination. The Company is an equal opportunity employer and will provide reasonable accommodations to those individuals who are unable to be vaccinated consistent with federal, state and local law

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.