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 team of experts as a Sr. Specialist, Regulatory Strategy! Take the lead in preparing document packages for regulatory submissions, ensuring compliance with local and regional registration requirements and company policies. Stay ahead of regulatory changes, maintain tracking systems, and recommend strategies for swift clinical trial approvals. Be the go-to contact for internal projects and program activities. Shape the future of regulatory strategy with us._
Your Contributions (include, but are not limited to):As a Regulatory Affairs Specialist where you will play a pivotal role in preparing and submitting critical documents to regulatory authorities with precision and finesse
You’ll have the opportunity to ensure that all regulatory submissions are of the highest quality, accuracy, and completeness, while also maintaining compliance information and acting as a key contact for internal company projects
Utilize your keen attention to detail and dedication to maintaining regulatory standards, you will oversee the review and revision procedures, coordinate program activities, and utilize cutting-edge tools like Smartsheet for seamless timeline tracking
If you thrive in a fast-paced environment, excel at ensuring consistency and accuracy, and are drawn to the opportunity to make a real impact in the biopharmaceutical industry, we want to hear from you
Additional duties as assigned
Requirements:BS/BA degree and 4+ years of relevant experience OR
Master’s and 2+ years of related experience OR
JD or PharmD or PhD and without experience
Must be able to effectively understand, interpret and apply company standards and regulatory guidance to all documents reviewed
Strong familiarity with regulatory documents
Strong familiarity with FDA regulations and ICH guidelines for regulatory submissions
Thorough understanding of laws, regulations, standards, and guidance governing drug development (e.g., US regulatory knowledge)
Demonstrated knowledge of US FDA and Ex-US ICH drug development regulatory guidelines to ensure compliance with local and regional requirements, as well as with company policies
Understands key business drivers and uses this understanding to accomplish work
Has strong understanding of processes, procedures and systems used to accomplish the work and recognizes downstream impact on other functional areas
Proficient with tools and processes that support work conducted by functional area
Ability to work as part of a team; may train lower levels
Excellent computer skills
Strong communications, problem-solving, analytical thinking skills
Detail oriented yet can see broader picture for department
Ability to meet multiple deadlines, with a high degree of accuracy and efficiency
Strong project management 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 $101,200.00-$146,550.00. 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 20% 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.