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.
What We Do:Neurocrine Biosciences is a leading 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, neuroendocrine, and neuropsychiatric disorders. The company’s diverse portfolio includes FDA-approved treatments for tardive dyskinesia, chorea associated with Huntington’s disease, 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, visit neurocrine.com, and follow the company on LinkedIn, X (Formerly Twitter) and Facebook. (*in collaboration with AbbVie)
About the Role:
Join our dynamic team at Neurocrine as a Senior Regulatory CMC Manager where you'll play a crucial role in shaping the regulatory CMC strategy and driving the successful preparation and approval of IND/CTA/MAA/NDA/BLA submissions. Be at the forefront of developing and commercializing innovative therapies, making a real impact on patient lives. If you're ready to make a difference in the biopharmaceutical industry, this is the role for you._
Your Contributions (include, but are not limited to):Play a key role in shaping the regulatory CMC strategy and execution for both commercial and development projects, ensuring adherence to IND/CTA preparation, maintenance, and update activities, and meticulously preparing for pivotal milestone meetings with regulatory agencies, with a strong focus on the CMC aspects
Craft CMC regulatory plans that drive optimal product development, aiming for prompt approvals from relevant regulatory authorities, while providing invaluable expertise on global regulatory CMC requirements to management and project teams
Offer expert guidance to the product development team within CMC areas, addressing all regulatory issues throughout the development, planning, compilation, and submission of IND/CTA/MAA/NDA/BLA, taking the lead in interactions and negotiations with regulatory agencies at every stage of development and registration
Potentially spearhead the preparation of regulatory submissions (IND/CTA/MAA/NDA/BLA), ensuring meticulous creation, review, and editing of reports and regulatory submissions
Actively collaborate with stakeholder groups to influence science-based regulatory decision-making, potentially serving as the regulatory CMC liaison with partner companies and contract manufacturers
Fulfill other duties as assigned, showcasing a commitment to excelling in all regulatory CMC responsibilities
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 OR
Ability to work independently with minimal direction, including functional representation within project teams and committees in order to attain group goals
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
Anticipates business and industry issues; recommends relevant process / technical / service improvements
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
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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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The annual base salary we reasonably expect to pay is $151,400.00-$219,400.00. 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.