Senior Regulatory Operations Manager

17 Dec, 2020

Jobs

Senior Regulatory Operations Manager

Neurocrine Biosciences
San Diego, CA

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 patient suffering and enhance lives.

What We Do:

Neurocrine Biosciences is a neuroscience-focused, biopharmaceutical company with 28 years of experience discovering and developing life-changing treatments for people with serious, challenging and under-addressed neurological, endocrine and psychiatric disorders. The company’s diverse portfolio includes FDA-approved treatments for tardive dyskinesia, Parkinson’s disease, endometriosis* and uterine fibroids*, with three pivotal and five mid-stage clinical programs in multiple therapeutic areas. Headquartered in San Diego, Neurocrine Biosciences specializes in targeting and interrupting disease-causing mechanisms involving the interconnected pathways of the nervous and endocrine systems. (*in collaboration with AbbVie)

About the Role:

The Senior Regulatory Operations Manager will be responsible for the management and execution of regulatory operations activities for investigational drug and biologic products ensuring successful preparation and filing of regulatory submissions to Global Health Authorities.

_

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

  • Manages end-to-end process for electronic submissions and QC documentation supporting global submissions in accordance with regulations and guidance.

  • Prepares and communicates Regulatory Operations submission timelines to the Regulatory Affairs Leads.

  • Provides publishing and submissions guidance to project teams ensuring all regulatory documentation is complete, of high quality, and is electronically functional.

  • Ensures the production of high quality paper and electronic submissions.

  • Reviews, recommends and authors Standard Operating Procedures/Work Instructions for the department.

  • Participates in validation activities for systems supporting submission activities within Regulatory Affairs.

  • Maintains up-to-date knowledge of the electronic submissions environment, regulations, and guidelines.

  • Responsible for identifying regulatory operations risks and mitigation plans.

  • Other duties as assigned.

Requirements

  • BS/BA degree in Life Sciences or other applicable field and 12+ years of Regulatory experience in the pharmaceutical regulated industry.

  • Experience with the Electronic Common Technical Document (eCTD) format for FDA submissions including IND and NDA submissions and experience with Health Canada and EMA is highly preferred. Some management/leadership experience preferred. OR

  • Master’s degree in Life Sciences or other applicable field and 10+ years of similar experience noted above.

  • Proficiency with electronic Common Technical Document (eCTD) and Regulatory Information Management, required.

  • Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint, etc) and Adobe Professional, required.

  • Advanced knowledge of the following is required: ISI Toolbox, Liquent InSight Publisher or similar eCTD software, electronic document management systems (eg Livelink, Veeva Vault).

  • Attention to detail, excellent organizational skills, and ability to manage competing priorities required.

  • Advanced knowledge of standard concepts, practices, and procedures of system implementation, document management and control.

  • Anticipates business and industry issues; recommends relevant process / technical / service improvements.

  • Demonstrates broad expertise or unique knowledge.

  • Considered a regulatory operations subject matter expert within pharmaceutical industry.

  • 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 serve on multiple program teams.

  • Good leadership, mentoring skills and abilities; typically leads lower levels and/or indirect teams.

  • Excellent computer skills.

  • Excellent communications, problem-solving, and 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.

Neurocrine Biosciences is an EEO/AA/Disability/Vets employer.

OUR VALUES:                                                      

  • PASSION: We are driven and love what we do. We are committed to our goals and to making a difference.
  • INTEGRITY:  We do the right thing for patients and our community. We take accountability. We speak up.
  • COLLABORATION: We trust one another. We are inclusive. We are respectful. We are transparent. Together we succeed.    
  • INNOVATION: We seek and create optimal solutions.
  • TENACITY:  We do not quit. We adapt. We accomplish what others cannot.

Come join our team during this exciting time of growth and opportunities!

During the COVID-19 Outbreak we are committed to our hiring process. The health and safety of our employees and prospective employees take priority which means at this time our process will include virtual video discussions, interviews & onboarding.

Another reason why Neurocrine Biosciences, was certified as a Great Place to Work

Learn more here

Job posted: 2020-12-17