Director, Regulatory Strategy

Neurocrine Biosciences • San Diego, CA

1d

About The Position

Neurocrine Biosciences is a leading biopharmaceutical company dedicated to discovering, developing, and commercializing life-changing treatments for patients with under-addressed neurological, psychiatric, endocrine, and immunological disorders. The company has a diverse portfolio including FDA-approved treatments and a robust pipeline. This role is responsible for directing regulatory activities for assigned development products to ensure alignment and compliance with local and regional registration requirements and company policies. The position involves developing and implementing global regulatory strategies, ensuring timely preparation and submission of documents to regulatory authorities, collaborating with development partners, and maintaining compliance. The successful candidate will provide guidance on regulatory requirements, processes, and logistics for global drug development from preclinical stages through initial marketing applications and life cycle management.

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.
• OR Master's degree in life sciences or related field AND 10+ years of related experience
• OR PhD in life sciences or related field AND 7+ years of related experience
• Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint, Access)
• Strong attention to detail and excellent verbal and written communication skills
• Effective people management skills
• Strong negotiation and influencing skills
• Detailed knowledge of FDA/EMA/ICH regulations and guidance for drug development, preparation and management of IND/CTA/NDA/MAA applications
• Ability to critically review regulatory scientific documents across the non-clinical and clinical disciplines

Nice To Haves

• 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)
• 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 having cross-functional impact

Responsibilities

• Responsible for the regulatory leadership of one or more development projects, including regulatory strategy, IND/CTA/NDA/MAA submission preparation, application maintenance and update activities, and interaction with regulatory agencies.
• Authoring and preparation of various submission documents, meeting requests, briefing documents, and coordination 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 for the strategic development, planning, compilation, and submission of IND/CTA and NDA/MAA.
• Serves as the designated program regulatory health authority contact and represents the company in interactions with regulatory agencies.
• Oversees the development of the dossier filing plan and associated regulatory activity timelines.
• Integrates global regulatory understanding and responsibilities in developing strategy and regulatory submission documents.
• Provides critical review of all documentation supporting regulatory applications, ensuring 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 a strategic regulatory liaison with partner companies.

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

What This Job Offers

• Job Type: Full-time
• Career Level: Director