Director – Regulatory CMC @ Cerevel Therapeutics

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 Director, Head of Regulatory CMC, the successful candidate will provide expertise in translating regulatory CMC requirements into innovative, efficient and practical strategies for development of Neuroscience candidates.

The candidate will partner with Global Regulatory Leads (GRLs) and Technical Operations Leads and have primary responsibility for the chemistry, manufacturing and controls strategy and writing details for Cerevel’s products and regulatory submissions. The candidate may also manage the activities of other CMC regulatory affairs staff or contract regulatory support in the performance of the duties outlined below.

Key Responsibilities

Create and deliver effective CMC strategies with appropriate risk assessment for projects across the development spectrum (Phase 1 through commercialization and LCM).
Partner with Global Regulatory Lead and Technical Operations Team lead to ensure CMC risks are appropriately communicated to Product Teams and senior management
Serve as primary author of Module 3 documentation for regulatory submissions while partnering with cross functional SMEs
Provide strategic input to technical teams to ensure product development meets global regulatory requirements
Review and provide assessments for change controls partnering with Quality colleagues to ensure investigational and commercial products maintain regulatory compliance
Provide and communicate CMC regulatory/GMP guidance documents and regulations regarding applicability and impact to internal programs.
Assist in the development, writing and implementation of internal guidance documentation for CMC regulatory and technical operations colleagues
Engage in appropriate activities in order to influence the regulatory environment through Health Authorities contacts and Trade Associations (eg, BIO) as appropriate

Required Qualifications

Minimum of 10 years of experience working in the pharmaceutical/biotechnology industry with direct experience in CMC Regulatory Affairs; Regulatory Affairs Certification (RAC) a plus
Demonstrated experience in the preparation and submission of INDs, CTAs, and NDAs/Marketing Applications
Experience with Health Authority reviews, queries and responses
Expert knowledge with GMP/ICH requirements and guidance in major markets, especially US and EU
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

Education

BS scientific degree essential. 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 essential

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.

Key Responsibilities

Required Qualifications

Desired Qualifications

Education

6 month growth

1 year growth

2 year growth