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.
Biotechnology, Pharmaceuticals, Quality/Risk Management, US Regulatory Affairs
4 Year Degree
Join an exciting early stage Arch Ventures backed CNS company in creating the next generation of treatments for neurodegenerative CNS disorders. Lead a successful IND and first meetings with the FDA.
Take part of our mission to restore hope for people affected by neurodegenerative disorders by driving the regenerative power of the human body. We seek a talented and successful individual who is inspired to improve healthcare and the lives of the patients we serve. We are team-based, highly energized, and inspired to excellence.
As Director/Senior Director, Regulatory Affairs, develop and execute a regulatory strategy and plan for transitioning drug discovery compounds from preclinical/FIH stages to clinical POC phases that will drive decision making for entering into late-stage clinical studies, registration filings and approvals.
Provide strategic and tactical regulatory leadership for drug development programs, including health authority interactions and regulatory submissions, to the cross-functional team while ensuring effective communication with key internal/external stakeholders, business partners and representatives of the US Food and Drug Administration and other Health Authorities.
Serve as an influential and well-respected spokesperson with staff at FDA and other Health Authorities, including leading meetings and preparations to facilitate expedited approval of original applications and supplements.
Provide de-risking development strategies and evaluating opportunities to accelerate development in a fast-paced environment.
Lead and contribute hands-on support in managing, planning, coordinating, and preparing all documents submitted to FDA and ex-US health authorities.
Contribute to the strategic leadership and development of policies and best practices to commensurate with the requirements of a small and rapidly growing company.
Strong knowledge of FDA regulations and EU CTA requirements.
Prior experience and success with filing INDs/CTAs/NDAs
Experience with both early and late stage drug development; CNS disease area is a plus!
Comfortable with setting strategies as well as taking a hands-on approach to all regulatory activities, such as regulatory documents including new INDs, CTAs, safety reports, Investigator Brochures, DSURs, briefing packages and other regulatory submissions, as required.
Experience interacting directly with FDA and other health authorities.
Bachelor’s Degree required (PharmD, or PhD preferred).
10+ years of experience in regulatory affairs within the biopharmaceutical industry is highly desired.
Additional Salary Information: In addition to a competitive compensation package with stock options, we also offer a comprehensive benefits package for our employees and their families, which includes medical, dental, vision, life, disability and a 401(k) plan.
Internal Number: 015
About Early stage Arch Ventures backed CNS company
We are an early stage, Arch Ventures backed CNS company creating the next generation of treatments for neurodegenerative CNS disorders. We are addressing significant unmet needs in neurodegeneration, including in rare CNS diseases, through the discovery and development of a pipeline of novel, brain-penetrant, small molecule therapeutics. Our company is located in the San Diego area and led by a highly experienced management team.
Our mission is to restore hope for people affected by neurodegenerative disorders by driving the regenerative power of the human body. We seek a talented and successful individual who is inspired to improve healthcare and the lives of the patients we serve. We are team-based, highly energized, and inspired to excellence.