Director, Regulatory Strategy

Neurocrine Biosciences, Inc.; San Diego (CA); On-site; USD 120,000 - 180,000; Full time

Job summary

Neurocrine Biosciences, Inc. seeks a senior regulatory leader to direct regulatory activities for development products from preclinical stages through life-cycle management, ensuring alignment with local and regional requirements and with company policies.

You will develop global regulatory strategies, lead IND/CTA/NDA/MAA submissions, and mentor teams while interacting with health authorities to secure timely approvals across markets.

Qualifications

• BS/BA degree in life sciences and 12+ years of pharma industry experience with regulatory submissions.
• Master's degree in life sciences and 10+ years of related experience.
• PhD in life sciences with 7+ years of related experience.
• Previous managerial experience is required.
• Recognized as an internal thought leader with extensive technical and business expertise.

Responsibilities

• Provide regulatory leadership for one or more development projects, including strategy and submission maintenance.
• Author and prepare submission documents and briefing materials; coordinate for health authority meetings.
• Develop regulatory strategies to enable earliest marketing approvals by global authorities.
• Advise management and project teams on regulatory issues for IND/CTA and NDA/MAA planning and submission.
• Serve as the regulatory health authority contact and liaison with regulators during all stages of development and commercialization.
• Oversee dossier filing plans and regulatory timelines.
• Integrate global regulatory responsibilities into development strategy and submissions.
• Critically review documentation to ensure compliance with data standards and requirements.

Skills

Regulatory leadership

Regulatory strategy

Health authority interaction

Project management

Strategic liaison

Documentation authoring

Communication skills

Education

Bachelor's degree in life sciences

Master's degree in life sciences

PhD in life sciences

Job description

Who We Are:

Neurocrine Biosciences is a leading biopharmaceutical company with a simple purpose: to relieve suffering for people with great needs. We are dedicated to discovering, developing and commercializing life-changing treatments for patients with under-addressed neurological, psychiatric, endocrine and immunological disorders. The company's diverse portfolio includes FDA-approved treatments for tardive dyskinesia, chorea associated with Huntington's disease, classic congenital adrenal hyperplasia, hyperphagia in Prader-Willi syndrome, endometriosis* and uterine fibroids*, as well as a robust pipeline including multiple compounds in mid- to late-phase clinical development across our core therapeutic areas. For more than three decades, we have applied our unique insight into neuroscience and the interconnections between brain and body systems to treat complex conditions. We relentlessly pursue medicines to ease the burden of debilitating diseases and disorders, because you deserve brave science. For more information, visit neurocrine.com , and follow the company on LinkedIn , X , Facebook and YouTube . ( *in collaboration with AbbVie )

At Neurocrine, strong leadership drives both business results and team success. We look for leaders who think strategically, anticipate what's ahead and set clear direction, while building and empowering high-performing teams. Successful leaders foster an environment where people are motivated to do their best work and deliver meaningful, measurable impact through sound decision-making and accountability.

About the Role:

Direct regulatory activities for assigned development products to ensure alignment and compliance with local and regional registration requirements as well as with company policies. Develops and implements global regulatory strategies, ensures timely preparation, review and submission of documents to regulatory authorities, collaborates with development partners, and maintains compliance with applicable regulatory requirements. The successful candidate will have practical knowledge and experience to provide guidance to program teams on the regulatory requirements, processes, and logistics to conduct global drug development activities for compounds from the preclinical stage through the initial marketing application, and life cycle management. _

Your Contributions (include, but are not limited to):

• Responsible for the regulatory leadership of one or more development projects, including responsibility for regulatory strategy, IND/CTA/NDA/MAA submission preparation, application maintenance and update activities, interaction with and preparation for key milestone meetings with regulatory agencies
• Authoring and preparation of various submission documents, meeting requests, briefing documents; coordination and preparation of teams for health authority meetings
• Develops regulatory strategies to ensure the earliest possible marketing approvals by global regulatory authorities
• Provides strategic guidance on global regulatory requirements to management and project teams on all regulatory issues for the strategic development, planning, compilation and submission of IND/CTA and NDA/MAA
• Serve as the designated program regulatory health authority contact. Represents the company by leading interactions with regulatory agencies during all stages of development, registration and commercialization
• Oversee development of dossier filing plan and associated regulatory activity timelines
• Integrate global regulatory understanding and responsibilities in developing strategy and development of regulatory submission documents
• Provide critical review of all documentation supporting regulatory applications; ensure compliance with internal data standards and regulatory authority submission requirements
• Actively engages with stakeholder groups to help shape science based regulatory decision making
• Acts as strategic regulatory liaison with partner companies

Requirements:

• BS/BA degree in life sciences or related field AND 12+ years of experience in Pharmaceutical industry, including drug development experience with demonstrated success in regulatory authority submission strategy, execution and health authority interaction. Prior US marketing application filing experience preferred; Ex-US experience strongly preferred. Experience in writing and leading regulatory documents (e.g., meeting requests/briefing book activities).
• Master's degree in life sciences or related field AND 10+ years of related experience
• PhD in life sciences or related field AND 7+ years of related experience
• Previous managerial experiences also required
• Recognized as an internal thought leader with extensive technical and business expertise within a strategic organization
• Applies in-depth knowledge of own function, business/commercial/scientific expertise to solve critical issues successfully and innovatively
• Evaluates key business/scientific challenges and completes complex, ambiguous initiatives havin