Director Regulatory Strategy
Confirmed live in the last 24 hours
Acadia Pharmaceuticals Inc.

501-1,000 employees

Develops therapies for central nervous system disorders.
Company Overview
Acadia Pharmaceuticals Inc. stands out as a leader in the healthcare industry with over 25 years of experience, particularly noted for developing the first and only approved therapy for hallucinations and delusions associated with Parkinson’s disease psychosis. The company's culture is characterized by a dedicated team of "care-ageous warriors" who are committed to improving the lives of patients and their families. Acadia's competitive edge lies in its robust late-stage development efforts focused on dementia-related psychosis, negative symptoms of schizophrenia, and Rett syndrome, as well as early-stage clinical research exploring novel approaches to pain management, cognition, and neuropsychiatric symptoms in central nervous system disorders.
Biotechnology

Company Stage

N/A

Total Funding

$813.4M

Founded

1993

Headquarters

San Diego, California

Growth & Insights
Headcount

6 month growth

6%

1 year growth

16%

2 year growth

18%
Locations
Princeton, NJ, USA
Experience Level
Entry
Junior
Mid
Senior
Expert
Desired Skills
Marketing
CategoriesNew
Legal & Compliance
Requirements
  • Bachelor’s degree in a life science or related field
  • 10 years progressively responsible experience, with 5 years in a leadership role
  • Experience as lead regulatory product strategist in two or more major regions in addition to the US, such as EU, Canada, or Japan
  • Strong knowledge of different functional document types that comprise eCTD regulatory submissions including clinical documents and other reports
  • Experience in supporting global clinical trial applications via CROs (e.g. CTIS)
  • Ability to communicate clearly and concisely, both in writing & verbally, with others in a professional manner
  • Keep abreast and analyze of submission and data standards, regulatory policies, procedures, security standards, GMP, and GCP
  • Ability to work cross-functionally to solve complex business process and technical problems, escalating concerns to senior management as appropriate
  • Ability to schedule team priorities with minimal supervision
  • Ability to work efficiently in a fast-paced environment where priorities change frequently to meet the business needs
Responsibilities
  • Developing and implementing global strategies to secure and maintain market approval for product(s) in the assigned development teams
  • Expanding therapeutic area and disease state knowledge
  • Ensuring strategic messaging and content of global regulatory dossiers
  • Serving as primary regulatory interface with health authorities
  • Proactively anticipating and mitigating regulatory risks
  • Ensuring compliance with global regulatory requirements
  • Serving as resource to team members for the regulatory requirements, processes, and logistics to conduct global drug development activities for compounds from the preclinical stage through approval, initial marketing, and life cycle management
  • Providing leadership and acting as a resource to the broader regulatory function, including peer mentorship of junior staff
  • Leading and supporting company objectives
  • Leading the regulatory project team to development of creative global strategies in line with applicable regulations to achieve business objectives for development and/or marketed products
  • Leading cross-functional stakeholders to ensure appropriate and clear strategic messaging in global regulatory dossiers and responses to requests from health authorities
  • Leading preparation of global regulatory product strategies for assigned products
  • Leading regulatory and cross-functional team in the preparation and maintenance of risk assessment and mitigation strategies and communicates plans to relevant stakeholders
  • Proactively researching and presenting regulatory assessments and recommendations
  • Making decisions regarding work processes or operational plans and schedules to achieve the program objectives
  • Maintaining compliance with reporting requirements for existing applications (IND, NDA, MAA)
  • Preparing and submitting all maintenance submissions
  • Participating in professional associations, industry, and trade groups to keep current on regulatory intelligence and applying knowledge to assigned programs
  • Working independently under the direction of supervisor
Desired Qualifications
  • Strong global development foundation with business acumen