Neurocrine Biosciences · 9 hours ago
Director, Regulatory CMC
San Diego, CA
Full-time
Onsite
Director/Executive
$188K/yr - $256K/yr
7+ years expNeurocrine Biosciences is a leading neuroscience-focused, biopharmaceutical company dedicated to discovering and developing life-changing treatments for patients with neurological disorders. The Director of Regulatory CMC will be responsible for strategic leadership in regulatory compliance and submissions for commercial products and development projects.
BiotechnologyHealth CarePharmaceutical
Responsibilities
Responsible for the regulatory CMC leadership of one or more commercial and development projects, including responsibility for regulatory strategy, IND/CTA preparation, maintenance and update activities, interaction with and preparation for key milestone meetings with regulatory agencies with focus on the CMC aspects
Develops CMC regulatory strategies to ensure optimal product development leading to the earliest possible approvals by relevant regulatory authorities
Provides strategic guidance on global regulatory CMC requirements to management and project teams
Provides guidance to senior management and departments within CMC areas on all regulatory issues for the strategic development, planning, compilation and submission of assigned IND/CTA/MAA/NDA/BLA
May represent the company by leading interactions and negotiations with regulatory agencies during all stages of development and registration
Manages preparation of assigned regulatory submissions (IND/CTA/MAA/NDA/BLA)
Reviews and approves reports intended for use in regulatory submissions
Actively engages with stakeholder groups to help shape science based regulatory decision making
Acts as regulatory CMC liaison with partner companies and contract manufacturers
Provides expertise in translating regulatory requirements into practical, workable plans
Interacts with regulatory agencies for assigned projects
Selects, develops and evaluates personnel to ensure the efficient operation of the function
Other duties as assigned
Qualification
Required
BS/BA degree AND 12+ years experience in Regulatory Affairs in the Pharmaceutical/Biotech industry
Prior project regulatory leadership experience with specific focus on the CMC aspects for small molecules, biologics, and/or gene therapies
Extensive previous managerial experiences also required
Acts as a 'trusted advisor' across the company and may be recognized as an external expert
Provides strategy, vision and direction regarding issues that may have company-wide impact
Requires in-depth knowledge of the functional area, business strategies, and the company's goals
Possesses industry-leading knowledge
Ability to apply advanced analytical thought and judgment
Strong leadership, coaching, employee development skills
Ability to influence others with or without authority at all levels of the organization
Proactive, innovative, with excellent problem-solving skills
Ability to work in a cross functional team and matrix environment
Excellent written, presentation, and verbal communication skills
Extensive project regulatory leadership and expertise, specifically focused on the CMC aspects for small molecules, biologics, and/or gene therapies
Detailed knowledge of FDA and EMA regulations and guidance for drug development, preparation and management of IND/CTA/MAA/NDA/BLA
Demonstrated leadership expertise in preparation and preferably, negotiation to marketing approval in major markets
Preferred
Master's degree preferred AND 10+ years similar experience noted above
PhD preferred AND 7+ years similar experience noted above
Benefits
Annual bonus with a target of 35% of the earned base salary
Eligibility to participate in our equity based long term incentive program
Retirement savings plan (with company match)
Paid vacation
Holiday and personal days
Paid caregiver/parental and medical leave
Health benefits to include medical, prescription drug, dental and vision coverage in accordance with the terms and conditions of the applicable plans
Company
Neurocrine Biosciences
Neurocrine Biosciences engages in the discovery and development of drugs for the treatment of neurological and endocrine-related diseases.
1001-5000 employees
Funding
Current Stage
Public CompanyTotal Funding
$260MKey Investors
Venrock
2015-02-19Post Ipo Equity· $250M
2009-12-17Post Ipo Equity· $10M
1996-05-31IPO
Leadership Team
Matt Abernethy
Chief Financial Officer
D
Dimitri Grigoriadis
VP, Research
Recent News
BioWorld Financial Watch
2026-01-16
Company data provided by crunchbase