Associate Director/Director, Regulatory Affairs

by | Sep 22, 2021 | Expired Jobs

Company Name:

Longboard Pharmaceuticals

Job Location:

United States/Remote

Position Title:

Associate Director/Director, Regulatory Affairs

Position Type:

Full time

General Job Description

Working in a team environment, the Associate Director/Director, Regulatory Affairs will be responsible for development of regulatory strategy as well as hands-on management of all technical and operational aspects related to the regulatory lifecycle (e.g., from preclinical candidate designation through registration) of assigned Longboard Pharmaceutical products.

Responsibilities:

  • Strategic Planning: Represent the Regulatory Affairs department on multidisciplinary product development teams, develop and implement regulatory strategy for one or more programs, research regulatory precedent related to product class and therapeutic area(s) and assess implications for LP product development/registration, contribute to global product development plans and target product profiles, lead preparation of pediatric investigation plans and rare disease designation applications
  • Operations: Manage all operational aspects of regulatory submissions, including maintaining timelines; organizing submission content; and coordinating the internal/external authoring and review of components of original investigational drug applications, amendments, safety and annual reports, interface with external Regulatory Operations group in the compilation of regulatory submissions in electronic common technical document format, serve as primary liaison for communication with regulatory health authority on assigned programs, prepare team for and lead the conduct of milestone development meetings with regulatory health authority
  • Compliance: Review and communicate current and emerging regulatory requirements for quality, preclinical, and clinical programs to ensure compliance of all development activities with applicable US and international regulations and guidelines, participate in the development and review of standard operating procedures (SOPs); ensure SOPs are in compliance with current regulatory requirements, monitor company progress toward fulfillment of regulatory commitments

Qualifications:

  • Bachelor’s degree in life sciences required; advanced degree preferred
  • Regulatory Affairs Certification (RAC) a plus
  • Minimum 7 years pharmaceutical Regulatory Affairs experience with focus in development of drugs/biologics
  • Direct experience in preparation, submission and lifecycle management of investigational/marketing applications, including as primary regulatory author
  • Experience negotiating and directly interfacing with US and international regulatory authorities
  • In depth knowledge of GxP/ICH guidelines and regulations
  • Experience in CNS-related therapeutic area and rare disease development a plus
  • Strong written and verbal communication, and ability to communicate regulatory strategy to key stakeholders at all levels of the organization
  • High level of analytical, organizational, and interpersonal skills
  • Ability to work in a dynamic environment with a high degree of flexibility
  • Proven ability to interact effectively across multiple functional groups and projects
  • Ability to travel up to 20% (US and International)

Application Information & Contact (How to Apply)

Please email your resume to [email protected]

Learn more about the company here