Specialist, Regulatory Business Operations
Neurocrine Biosciences
1 month ago
Remote friendly (San Diego, CA)
United States
Operations
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.
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
- Coordinate 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
- Experience in a specific functional discipline while working to acquire higher-level knowledge and skills
- Comfortable with tools and processes that support work conducted by the 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; ability to multitask, prioritize, and strong attention to detail
- Strong collaboration skills and attention to detail
- Strong interpersonal and organizational skills; excellent meeting management, verbal and written communication skills required
- Ability to adapt to modifications and changes to project plans; flexibility to implement new strategies and tactics
Benefits
- Retirement savings plan (with company match)
- Paid vacation, holiday and personal days
- Paid caregiver/parental and medical leave
- Health benefits including medical, prescription drug, dental and vision coverage (per plan terms)
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.
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
- Coordinate 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
- Experience in a specific functional discipline while working to acquire higher-level knowledge and skills
- Comfortable with tools and processes that support work conducted by the 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; ability to multitask, prioritize, and strong attention to detail
- Strong collaboration skills and attention to detail
- Strong interpersonal and organizational skills; excellent meeting management, verbal and written communication skills required
- Ability to adapt to modifications and changes to project plans; flexibility to implement new strategies and tactics
Benefits
- Retirement savings plan (with company match)
- Paid vacation, holiday and personal days
- Paid caregiver/parental and medical leave
- Health benefits including medical, prescription drug, dental and vision coverage (per plan terms)