Specialist, Regulatory Business Operations

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 Biosciences is 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, visit neurocrine.com, and follow the company on LinkedIn, X and Facebook. (*in collaboration with AbbVie)

About the Role:Responsible for supporting the Regulatory Business Operations function with development and maintenance of department regulatory processes and critical regulatory submissions toolkit infrastructure. Support cross-functional interactions with internal and external stakeholders to ensure regulatory needs and expectations are appropriately maintained for established partnership-level CROs.

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

• Develop and maintain departmental regulatory processes (e.g., SOPs, templates, guidelines, etc.) including new and revised cross-functional procedures

• Contribute to regulatory review and provide input for new and revised cross-functional procedures

• Support maintenance and deployment of critical regulatory submissions toolkit infrastructure (e.g., Smartsheet submission timeline(s), Smartsheet Content Plan/Document Tracker, Veeva RIM Content Plan updates post handoff from Regulatory Operations)

• Assist in monitoring and improving tracking/control systems for critical submissions metrics reporting

• Support implementation of internal processes for new/emerging regulations with broad cross-functional/cross-regulatory implications

• Coordination of regulatory internal process audit including preparation, conduct, and responses

• Other duties as assigned

Requirements:

• BS/BA degree AND 2+ years of experience in Biotech or Pharmaceutical industry including hands-on management of regulatory projects and business processes experience OR

• Master's Degree AND some related experience as noted above

• Understands Neurocrine's business objectives and developing understanding of Neurocrine's services and customers

• Has experience in specific functional discipline while working to acquire higher-level knowledge and skills

• Comfortable with tools and processes that support work conducted by functional area

• Ability to work as part of a team

• Strong computer skills

• Good communications, problem-solving, analytical thinking skills

• Good project management skills

• Experience with timeline development and management software preferred (e.g., MS Project, Smartsheet)

• Well organized with the ability to multitask, prioritize, and strong attention to detail

• Strong collaboration skills and attention to detail

• Strong interpersonal and organizational skills and excellent meeting management, verbal and written communication skills are required

• Ability to adapt to modification and changes to project plans, demonstrating flexibility to implement new strategies and tactics to accommodate these changes

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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 $81,000.00-$111,000.00. 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 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.