Sr. Regulatory CMC Manager

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)

About the Role:Responsible for contributing to the strategy and execution of regulatory CMC plans for assigned development and commercial projects leading to successful preparation and approval of IND/CTA/MAA/NDA/BLA submissions in a timely and efficient manner.

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

• Responsible for contributing to 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 with focus on the CMC aspects

• Develops CMC regulatory plans to ensure optimal product development leading to the earliest possible approvals by relevant regulatory authorities

• Provides expertise on global regulatory CMC requirements to 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

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

• May lead 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

• May act as regulatory CMC liaison with partner companies and contract manufacturers

• Other duties as assigned

Requirements:

• BS/BA degree in Life/Health Sciences or related field AND 8+ years of Regulatory Affairs experience in a pharmaceutical company with focus on CMC activities. Experience managing external contract services, and direct interaction with FDA. OR

• Master’s degree in Life/Health Sciences or related field AND 6+ years of similar experience noted above OR

• PhD AND 4+ years of similar experience noted above

• Demonstrates broad expertise or unique knowledge

• Considered an expert within the company and may have external presence in area of expertise

• Applies in-depth expertise in discipline and broad knowledge of other closely related areas to improve efficiency of team

• 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 communications, 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

• Anticipates business and industry issues; recommends relevant process / technical / service improvements

• Strong knowledge of FDA regulations, including current Good Manufacturing Practices

• Proven experience with electronic filing (eCTD), electronic document management systems and with document review and approval processes

• Ability to work independently with minimal direction, including functional representation within project teams and committees in order to attain group goals

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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.

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The annual base salary we reasonably expect to pay is $158,100.00-$216,000.00. 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 30% 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.