Sr. Manager, Regulatory Affairs Clin/Non clinLocation San Rafael, California Apply
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.
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 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 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’s/CTAs, NDA’s and BLA’s.
- Oversee the archiving of HA submissions and correspondence
The 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’s degrees
- Nonclinical / Clinical Regulatory Affairs experience preferred
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.
In the U.S., the salary range for this position is $ 122,600 to $ 183,900 per year, which factors in various geographic regions. The base pay actually offered will take into account internal equity and also may vary depending on the candidate's geographic region, job-related knowledge, skills, and experience among other factors. A discretionary bonus and/or long-term incentive units may be provided as part of the compensation package, in addition to the full range of medical, financial, and/or other benefits, dependent on the level and position offered.