Simplify Logo

Full-Time

Senior Manager

Regulatory CMC

Confirmed live in the last 24 hours

Acadia Pharmaceuticals Inc.

Acadia Pharmaceuticals Inc.

501-1,000 employees

Develops therapies for neurological disorders

Biotechnology
Healthcare

Compensation Overview

$128k - $160.2kAnnually

+ Bonus + Equity Awards

Senior, Expert

San Diego, CA, USA

Hybrid model requires in-office presence three days per week on average.

Category
Healthcare Administration & Support
Medical, Clinical & Veterinary
Required Skills
Marketing
Requirements
  • Bachelor’s degree in a life science or related field.
  • Targeting at least 7 years of progressively responsible experience in CMC Regulatory Affairs with a focus on small molecule drug development.
  • Knowledge and understanding of global regulatory CMC requirements and guidelines.
  • Previous experience in the preparation and submission of the CMC components of IND/CTA and NDA and ex-US MAA submissions.
  • Ability to work in a cross-functional team environment and manage competing priorities.
  • Strong interpersonal skill, attention to detail and excellent organizational, computer, and documentation.
  • Ability to meet deadlines and perform multiple tasks in a fast paced setting.
  • Demonstrated personal initiative, responsibility, flexibility, the ability to work under limited supervision, and ability to handle multiple project assignments.
  • Skilled at negotiating with/influencing business partners and departmental leaders regarding matters of significance to the department or segments of the organization.
  • Adept at communicating a clear vision among team members effectively aligning resources to achieve functional area goals.
Responsibilities
  • Supports CMC regulatory affairs activities for marketed products and compounds in development in line with US and ex-US regulatory requirements.
  • Coordinates with R&D, Pharmaceutical Development, Manufacturing, Quality and Regulatory colleagues and other functional areas to develop and implement CMC regulatory strategy.
  • Organizes and contributes to the timely preparation of high quality CMC sections of INDs/CTAs, NDAs, MAAs and amendments for submission to global regulatory authorities, supporting the conduct of clinical trials and marketing applications.
  • Contributes as a key regulatory representative with external parties for CMC development activities.
  • Interacts with regulatory agencies for CMC development activities as required.
  • Supports the regulatory function on development teams providing CMC regulatory guidance and strategy including identifying and assessing/mitigating regulatory risks.
  • Participates in ensuring compliance of CMC activities with applicable regulatory requirements.
  • Evaluates Manufacturing processes and changes, assesses the regulatory implications and supports their implementation.
  • Maintains current knowledge of the relevant guidelines and regulations and determine applicability to company activities.
  • Other duties as assigned.
Acadia Pharmaceuticals Inc.

Acadia Pharmaceuticals Inc.

View

Acadia Pharmaceuticals develops therapies for neurological disorders, focusing on conditions like Parkinson's disease, schizophrenia, and Rett syndrome. Their products are created through extensive research and development, followed by rigorous clinical trials to ensure safety and effectiveness. Once approved by regulatory bodies like the FDA, these therapies are marketed to patients and healthcare providers. Acadia stands out from competitors by concentrating on areas with significant unmet medical needs and fostering strategic partnerships to enhance their research and market presence. The company's goal is to improve the quality of life for individuals with neurological conditions through effective treatments.

Company Stage

IPO

Total Funding

$813.4M

Headquarters

Dallas, Texas

Founded

1993

Simplify Jobs

Simplify's Take

What believers are saying

  • Acadia's launch of Magnolia's Guide to Adventuring showcases their innovative approach to raising disease awareness and redefining perceptions of Rett syndrome.
  • The acceptance of trofinetide for priority review by Health Canada could lead to significant market expansion and first-mover advantage in treating Rett syndrome in Canada.
  • The appointment of Dr. Elizabeth H. Z. Thompson as Executive Vice President, Head of Research and Development, signals a strong commitment to advancing their R&D capabilities.

What critics are saying

  • The failure of the Phase III ADVANCE-2 trial for pimavanserin in schizophrenia highlights the high-risk nature of drug development in the biopharmaceutical sector.
  • Dependence on regulatory approvals, such as the FDA and Health Canada, introduces uncertainty and potential delays in bringing therapies to market.

What makes Acadia Pharmaceuticals Inc. unique

  • Acadia Pharmaceuticals focuses exclusively on neurological disorders, setting it apart from competitors with broader therapeutic areas.
  • Their commitment to corporate social responsibility, including initiatives like the Rett Sibling Scholarship, enhances their reputation and community engagement.
  • Acadia's strategic partnerships and corporate sponsorships amplify their research capabilities and market reach, distinguishing them from competitors who may not leverage such collaborations.