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Sr. Manager, Regulatory Clin/Nonclin

Location United States, Remote

Workstyle Open to Hybrid
BioMarin is the world leader in delivering therapeutics that provide meaningful advances to patients who live with serious and life-threatening rare genetic diseases. We target diseases that lack effective therapies and affect relatively small numbers of patients, many of whom are children. These conditions are often inherited, difficult to diagnose, progressively debilitating and have few, if any, treatment options. BioMarin will continue to focus on advancing therapies that are the first or best of their kind.

BioMarin’s Research & Development group is responsible for everything from research and discovery to post-market clinical development. Research & Development involves all bench and clinical research and the associated groups that support those endeavors. Our teams work on developing first-in-class and best-in-class therapeutics that provide meaningful advances to patients who live with rare diseases. Come join our team and make a meaningful impact on patients’ lives.

Summary

The Senior Manager supports Regulatory leadership in the development and execution of global nonclinical / clinical regulatory strategies through a program’s lifecycle.  The Manager leads the execution of delegated activities, including preparation for HA interactions and the oversight of regulatory submissions, in support of the strategy.  The Senior Manager may take on a leadership role for key non-clinical / clinical regulatory submissions and Health Authority engagement activities as delegated.

The BioMarin Senior Manager will support leadership in the development of Regulatory Nonclinical / Clinical operational objectives and work plans and will work closely with functional management to obtain review and buy-in to these plans.  The Senior Manager will work collaboratively in a cross functional environment on a diverse range of topics that require in-depth Nonclinical / Clinical knowledge, understanding of industry trends and analytical ability to develop options and solutions for presentation to, and approval by, senior leadership.

Responsibilities

The RNC Sr. Manager responsibilities may vary depending upon product regulatory lifecycle and may include the leadership of selected activities which will be delegated by the Global Regulatory Lead or Regulatory Nonclinical/ Clinical Lead and may include the following:

Development Stage Product

  • Support the development of the nonclinical / clinical regulatory strategy and plan.
  • Assist with selected planning, document development and meeting execution activities in preparation for HA meetings / interactions.
  • Participate in Study Execution Teams for assigned products and identify relevant regulatory considerations for discussion with RNC Lead.
  • Collaborate with CROs that are contracted to perform regulatory submissions/HA interactions for global clinical trials.
  • With oversight by RNC lead, develop and coordinate the core nonclinical / clinical content of regulatory submissions.
  • Responsible for ensuring high quality nonclin/clinical content that adheres to regulations and guidances.
  • Lead the maintenance activities of IND/CTAs throughout the life of the studies.
  • Assist with the preparation of HA submission packages including but not limited to compiling relevant materials (Protocols, Clinical Study Reports, Briefing Books, etc.) and completing regulatory documents/forms for internal review.
  • Collaborate with Reg PM to create and align submission timelines.
  • Collaborate with Reg Ops to provide final documents and QC published outputs for submissions to HA.
  • Organize and maintain the administrative, nonclinical, and clinical portions of IND’s, NDA’s and BLA’s.
  • Oversee the archiving of HA submissions and correspondence, provide support as necessary

General

  • Attend relevant functional area and project team meetings.
  • Review, understand and stay up to date on regulations, guidelines relevant to responsibilities.
  • Review documents (SOPs, protocols and reports) related to Clinical or Nonclinical studies as necessary.
  • Ensure that the PM timelines and tracker accurately reflect submission plans.

Education & Experience

  • Degree in health or life sciences, including chemistry, molecular biology, or similar. PhD preferred, Masters/Bachelors acceptable with relevant experience
  • 6 + year experience with PhD; 8+ years with Masters or bachelor’s degrees
  • Nonclinical / Clinical Regulatory Affairs experience preferred
  • 0-1 year of line management experience preferred

PLEASE NOTE: Absent a Medical or Religious reason that prohibits vaccinations, all our incoming employees must be vaccinated for COVID-19.

Also all Compensation will be determined on cost of living where candidate resides

We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, sexual orientation, national origin, disability status, protected veteran status, or any other characteristic protected by law.

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We treat rare diseases, and that gives us rare opportunities. Chris Brodeur, Director, Corporate Compliance
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