Director – Regulatory CMC
Confirmed live in the last 24 hours
Cerevel Therapeutics

201-500 employees

Develops therapies for central nervous system disorders
Company Overview
Cerevel Therapeutics stands out as a leading biopharmaceutical company with a concentrated focus on developing therapies for central nervous system disorders, a field that impacts hundreds of millions globally. Their competitive edge lies in their robust portfolio of experimental neuroscience therapies, including three clinical-stage compounds and several pre-clinical compounds, targeting a wide range of disorders such as Parkinson’s, Alzheimer’s, and epilepsy. The company's culture is driven by a commitment to understanding neurocircuitry deficits, which fuels their research and development efforts towards addressing these underserved areas and communities.
Biotechnology

Company Stage

N/A

Total Funding

$1.8B

Founded

2018

Headquarters

Cambridge, Massachusetts

Growth & Insights
Headcount

6 month growth

7%

1 year growth

15%

2 year growth

57%
Locations
Remote in USA
Experience Level
Entry
Junior
Mid
Senior
Expert
Desired Skills
Communications
Marketing
CategoriesNew
Risk & Compliance
Legal & Compliance
Requirements
  • 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
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