Neurocrine Biosciences
Sr. Director, Regulatory Strategy - Biologics
Neurocrine Biosciences, San Diego, California, United States, 92189
Sr. Director, Regulatory Strategy - Biologics page is loaded Sr. Director, Regulatory Strategy - Biologics Apply remote type Hybrid locations US CA San Diego time type Full time posted on Posted 2 Days Ago job requisition id R5727
Who We Are:
At Neurocrine Biosciences, we pride ourselves on having a strong, inclusive, and positive culture based on our shared purpose and values. We know what it takes to be great, and we are as passionate about our people as we are about our purpose - to relieve suffering for people with great needs. What We Do:
Neurocrine Biosciencesis a leading neuroscience-focused, biopharmaceutical company with a simple purpose: to relieve suffering for people with great needs. We are dedicated to discovering and developing life-changing treatments for patients with under-addressed neurological, neuroendocrine and neuropsychiatric disorders. The company's diverse portfolio includes FDA-approved treatments for tardive dyskinesia, chorea associated with Huntington's disease, classic congenital adrenal hyperplasia, 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 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, visitneurocrine.com , and follow the company onLinkedIn ,X andFacebook . ( *in collaboration with AbbVie ) 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. _ 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
#LI-SA1 Neurocrine Biosciences is an EEO/Disability/Vets employer. We are committed to building a workplace of belonging, respect, and empowerment , and we recognize there are a variety of ways to meet our requirements. We are looking for the best candidate for the job and encourage you to apply even if your experience or qualifications don’t line up to exactly what we have outlined in the job description. _ 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. About Us
We are a top place to work. Neurocrine Biosciences was named one of the FORTUNE Best Workplaces in Biopharma 2024. We were also named a Great Place to Work Certified company. PASSION:
We are driven and love what we do. We are committed to our goals and to making a difference. INTEGRITY: We do the right thing for patients and our community. We take accountability. We speak up. COLLABORATION : We trust one another. We are inclusive. We are respectful. We are transparent. Together we succeed. INNOVATION : We seek and create optimal solutions. TENACITY: We do not quit. We adapt. We accomplish what others cannot. Come join our team during this exciting time of growth and opportunities!
#J-18808-Ljbffr
Who We Are:
At Neurocrine Biosciences, we pride ourselves on having a strong, inclusive, and positive culture based on our shared purpose and values. We know what it takes to be great, and we are as passionate about our people as we are about our purpose - to relieve suffering for people with great needs. What We Do:
Neurocrine Biosciencesis a leading neuroscience-focused, biopharmaceutical company with a simple purpose: to relieve suffering for people with great needs. We are dedicated to discovering and developing life-changing treatments for patients with under-addressed neurological, neuroendocrine and neuropsychiatric disorders. The company's diverse portfolio includes FDA-approved treatments for tardive dyskinesia, chorea associated with Huntington's disease, classic congenital adrenal hyperplasia, 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 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, visitneurocrine.com , and follow the company onLinkedIn ,X andFacebook . ( *in collaboration with AbbVie ) 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. _ 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
#LI-SA1 Neurocrine Biosciences is an EEO/Disability/Vets employer. We are committed to building a workplace of belonging, respect, and empowerment , and we recognize there are a variety of ways to meet our requirements. We are looking for the best candidate for the job and encourage you to apply even if your experience or qualifications don’t line up to exactly what we have outlined in the job description. _ 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. About Us
We are a top place to work. Neurocrine Biosciences was named one of the FORTUNE Best Workplaces in Biopharma 2024. We were also named a Great Place to Work Certified company. PASSION:
We are driven and love what we do. We are committed to our goals and to making a difference. INTEGRITY: We do the right thing for patients and our community. We take accountability. We speak up. COLLABORATION : We trust one another. We are inclusive. We are respectful. We are transparent. Together we succeed. INNOVATION : We seek and create optimal solutions. TENACITY: We do not quit. We adapt. We accomplish what others cannot. Come join our team during this exciting time of growth and opportunities!
#J-18808-Ljbffr