Assoc. Regulatory CMC Director

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, but few options.

Neurocrine Biosciences is a neuroscience-focused, biopharmaceutical company with a simple purpose: to relieve suffering for people with great needs, but few options. We are dedicated to discovering and developing life-changing treatments for patients with under-addressed neurological, endocrine and psychiatric disorders. The company's diverse portfolio includes FDA-approved treatments for tardive dyskinesia, Parkinson's disease, endometriosis* and uterine fibroids*, as well as clinical programs in multiple 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. *in collaboration with AbbVie

About the Role:

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• Responsible for the regulatory CMC strategy and execution for assigned commercial and development projects, including responsibility for significant contributions to IND/CTA preparation, maintenance and update activities, interaction with and preparation for key milestone meetings with regulatory agencies, e.g., FDA and EMA, with focus on the CMC aspects for scientific areas such as, biologics and/or small molecule modalities

• Leads development of CMC regulatory plans to ensure optimal product development leading to the earliest possible clinical clearances and/or approvals by relevant regulatory authorities

• Provides expertise on global regulatory CMC requirements for multiple scientific areas, such as, but not limited to: biologics modalities (peptides, monoclonal antibodies, cell and gene therapy) and/or small molecule program management and project teams

• Provides expert advice to product development team within CMC areas on all regulatory issues for the development, planning, compilation and submission of IND/CTA/MAA/NDA/BLA

• May lead interactions and negotiations with regulatory agencies during all stages of development and registration

• Leads preparation of regulatory submissions (IND/CTA/MAA/NDA/BLA)

• Creates, reviews and edits reports and regulatory submissions

• Actively engages with stakeholder groups to help shape science based regulatory decision making for multiple scientific areas including; biologics and small molecule

• May acts as regulatory CMC liaison within the company, with partner companies, and contract manufacturers (CMOs) or research organizations (CROs)

• Other duties as assigned

• Bachelor's degree in life science and 10 years of experience in regulatory affairs in the pharmaceutical/biotech industry. Individual must have prior project regulatory leadership experience with specific focus on the CMC aspects for small molecules, large molecules and/or cell/gene therapies, including detailed knowledge of FDA and EMA regulations and guidance for drug development, preparation and management of IND/CTA/MAA/NDA/BLA. Prior experience with preparation and preferably, negotiation to marketing approval in major markets is desirable. OR

• Master's degree in life science and 8 years of similar experience as noted above

• Sound knowledge and experienced with biologics (peptides, moncolonal antibodies, or cell and gene therapy) development and knowledge of small molecule CMC development.

• Familiarity with regulatory guidelines and regulations governing biologics and small molecule CMC topics including aseptic manufacturing and platform processing technology concepts for biologics).

• Able to critically review regulatory scientific documents across all CMC areas for biologics and small molecule modalities, as assigned.

• Regulatory expertise in project leadership, preferably negotiation with and conduct of meetings with the FDA and successful preparation and submission of IND/CTA/MAA/NDA/BLA with explicit CMC focus for biologics and/or small molecule modalities.

• Ability to effectively interact and communicate with multiple functions across the organization, including executive management

• Requires broad understanding of the processes, procedures and systems used to accomplish the team's work and familiarity with the underlying concepts in other disciplines within the function

• Applies in-depth understanding of how own discipline integrates within the function and understands contribution to Neurocrine's achievement of business objectives

• Ability to work as part of and lead multiple teams

• Good leadership, mentoring skills and abilities typically leads lower levels and/or indirect teams

• Excellent computer skills

• Excellent problem-solving, analytical thinking skills

• Sees broader picture and longer-term impact on division/company

• Ability to meet multiple deadlines across a variety of projects/programs, with a high degree of accuracy and efficiency

• Excellent project management, strong project leadership skills

• Excellent verbal and written communication skills

• Strong attention to detail

• Possess excellent interpersonal skills

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Neurocrine Biosciences is an EEO/AA/Disability/Vets employer.

We are committed to building a diverse, equitable, and inclusive workplace, 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.

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