Sr. Manager/ Associate Director, Regulatory Affairs Nonclin/Clin
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 Regulatory Affairs Nonclinical / Clinical team plays a key role in defining the BioMarin regulatory strategy and pathway for a product by leading the development and execution of the nonclinical / clinical regulatory strategy and plan in alignment the overall clinical development plan. This team will take a lead role in planning and developing relevant sections of regulatory filings required for product approvals. In addition, this team will lead planning, coordinating and engaging directly with Health Authorities before, during and after regulatory approval milestones.
The Senior Manager/ Associate Director supports Regulatory leadership in the development and execution of global nonclinical / clinical regulatory strategies through a program’s lifecycle. The individual 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/ Associate Director may take on a leadership role for key non-clinical / clinical regulatory submissions and Health Authority engagement activities as delegated
The RNC Sr. Manager/ Associate Director responsibilities may vary depending upon product regulatory lifecycle and may include the leadership of selected activities which will be delegated by the 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. Collaborate with team and/or Lead the submission of applications for INDs,CTAs, and GMOs in the US and internationally
- Lead the maintenance 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.
- Oversee the collaboration of Nonclin/clin 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
- 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
The Sr. Manager/ Associate Director may also take on additional Regulatory Nonclinical / Clinical product leadership responsibilities.
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 Master’s or bachelor’s degrees
- Nonclinical / Clinical Regulatory Affairs experience preferred
- 0-1 year of line management experience preferred
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.