Sr. Manager, Regulatory Affairs Clin\/Non clin
San Rafael, CA
BioMarin\u2019s 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 or best-in-class therapeutics that provide meaningful advances to patients. Come join our team and make a meaningful impact on patients\u2019 lives. SummaryThe Senior Manager supports Regulatory leadership in the development and execution of global nonclinical / clinical regulatory strategies through a program\u2019s lifecycle.\u00A0 The Manager leads the execution of delegated activities, including preparation for HA interactions and the oversight of regulatory submissions, in support of the strategy.\u00A0 The Senior Manager may take on a leadership role for key non-clinical / clinical regulatory submissions and Health Authority engagement activities as delegated.\u00A0The 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.\u00A0 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.\u00A0ResponsibilitiesThe 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 Regulatory Nonclinical/ Clinical Lead and may include the following:\u00A0Development 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 and associated partner 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 nonclinical/clinical content that adheres to regulations and guidances. Lead the maintenance of IND/CTAs throughout the life of the studies. Collaborate with Reg partners to ensure quality submissions that adhere to local requirements and timeline management considerations. Lead regulatory submission activities including but not limited to document authoring, review, and submission activities within Veeva platform. Assist with the preparation of HA submission packages including but not limited to compiling relevant materials (Orphan Drug Designation applications, US FDA Fast Track applications, Investigational New Drug (IND) applications, Protocols, Clinical Study Reports, Briefing Books, Annual Reporting, etc.) and completing regulatory documents/forms for internal review. Collaborate with Reg Program Specialists to create, align, and expediently modify submission timelines, as needed, in a changing competitive and regulatory landscape. Collaborate with Reg Operations to provide final documents and QC published outputs for submissions to HA. Organize and maintain the administrative, nonclinical, and clinical portions of IND\u2019s/CTAs, NDA\u2019s and BLA\u2019s. Oversee the archiving of HA submissions and correspondenceThe Sr. Manager 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 Masters or bachelor\u2019s degrees Nonclinical / Clinical Regulatory Affairs experience preferred \u00A0 PLEASE NOTE: Absent a Medical or Religious reason that prohibits vaccinations, all our incoming employees must be vaccinated for COVID-19. 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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