Specialist, Regulatory Business Operations

Neurocrine Biosciences • San Diego, CA

4d • $81,000 - $111,000

About The Position

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.

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
• 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

Nice To Haves

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

Responsibilities

• 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

Benefits

• retirement savings plan (with company match)
• paid vacation, holiday and personal days
• paid caregiver/parental and medical leave
• health benefits to include medical, prescription drug, dental and vision coverage in accordance with the terms and conditions of the applicable plans
• annual bonus with a target of 20% of the earned base salary and eligibility to participate in our equity based long term incentive program

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level