The regulatory function is vital in making safe and effective healthcare products available worldwide. Individuals who ensure regulatory compliance and prepare submissions, as well as those whose main job function is clinical affairs or quality assurance are all considered regulatory professionals.
One of our most valuable contributions to the profession is the Regulatory Code of Ethics. The Code of Ethics provides regulatory professionals with core values that hold them to the highest standards of professional conduct.
Like all professions, regulatory is based on a shared set of competencies. The Regulatory Competency Framework describes the essential elements of what is required of regulatory professionals at four major career and professional levels.
Join the brightest minds in regulatory at the annual Regulatory Convergence. See the global regulatory community in action. Intensive workshops. Topical sessions. Meet ups with regulators. This is where it all comes together.
Opportunity to join an extremely exciting and highly dynamic biopharmaceutical company focused on developing novel, transformative medicines for neurological diseases, with an initial focus on rare diseases.
Can be remote or on location in San Diego, CA.
The Regulatory Affairs Associate Director 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).
Essential Duties and Responsibilities
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 product development/registration
Contribute to global product development plans and target product profiles
Lead preparation of pediatric investigation plans and rare disease designation applications
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
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
Bachelor degree in a life sciences discipline; advanced degree preferred; Regulatory Affairs Certification 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
Telecommuting is allowed. Employer will assist with relocation costs.
Internal Number: 59
About Staffing Theory
Staffing Theory is a niche recruiting partner for the Life Sciences industry. We conduct pre-clinical, clinical, commercial, and internal placements globally, with experience in US, EU, Latin America, and Asia.