Senior Director, Regulatory Strategy - Biologics

Sr. Director, Regulatory Strategy - Biologics

remote type

Hybrid

locations

US CA San Diego

time type

Full time

 

About the Role:

Lead global regulatory strategy and execution for our innovative biologics/combination product portfolio. As Sr. Director of Regulatory Strategy, you will shape and drive regulatory pathways from preclinical through commercialization and lifecycle management. This key leadership role combines strategic oversight of registration requirements, regulatory submissions, and health authority interactions across markets. The ideal candidate brings deep expertise in global biologics regulations, with demonstrated success in navigating complex regulatory landscapes for combination products. Join our dynamic team to advance breakthrough therapies while ensuring regulatory excellence and compliance across all stages of drug development. The ideal candidate will live in the San Diego area and/or be able to come onsite 3 days a week.

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

• Responsible for the regulatory leadership of one or more development projects, including responsibility for global 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 oversight of various submission documents, meeting requests, briefing documents; coordination and preparation of teams for health authority meetings 

• Oversees the development and implementation of regulatory strategies to ensure the earliest possible marketing approvals by global regulatory authorities 

• Accountable for the strategic oversight 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, ensuring effective integration of global regulatory understanding and responsibilities in developing strategy and development of regulatory submission documents 

• For commercial products, provides regulatory guidance on all aspects of lifecycle management including strategic label development, safety label changes and regulatory management of the product 

• Serve as the primary designated program regulatory health authority contact and/or oversees designated health authority contacts. Represents Neurocrine by facilitating interactions with regulatory agencies during all stages of development, registration and commercialization 

• Lead the global regulatory subteam for assigned projects and oversee development of dossier filing plan and associated regulatory activity timelines 

• Responsible for critical review of all documentation supporting regulatory applications; effectively ensure compliance with internal data standards and regulatory authority submission requirements 

• Counsels and advises senior management on status of regulatory strategies and tactics, procedures and practices 

• Addresses complex issues, providing advanced regulatory solutions and guidance to cross-functional teams 

• Actively partner with key stakeholder groups to define science-based regulatory decision making 

• Acts as strategic regulatory liaison with partner companies 

• Conducts due diligence activities as a regulatory expert for assigned projects 

• Leads continuous improvement efforts on existing department processes and strategies, providing recommendations in area of expertise 

• Other duties as assigned 

 

Requirements:

• BS/BA degree in life sciences or related field and 15+ 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) OR 

• Master's degree in life sciences or related field and 13+ years of related experience OR 

• PhD in life sciences or related field and 10+ years of related experience 

• Extensive previous managerial experiences also required 

 

The annual base salary we reasonably expect to pay is $229,000.00-$331,650.00. Individual pay decisions depend on various factors, such as primary work location, complexity and responsibility of role, job duties/requirements, and relevant experience and skills. In addition, this position offers an annual bonus with a target of 35% of the earned base salary and eligibility to participate in our equity based long term incentive program. Benefits offered include a retirement savings plan (with company match), paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage in accordance with the terms and conditions of the applicable plans.