Associate II, Regulatory CMCLocation San Rafael, California Apply
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.
This position will be responsible for supporting a global Regulatory CMC team and regulatory activities associated with maintenance of commercial product licenses, including annual reports, preparation of change assessments, writing, organizing and maintaining CMC portions of domestic and international regulatory submissions. In addition, this position may support the relevant partner project teams, as needed and will work closely with the Regulatory Product lead to ensure all activities are on track, meeting expected deliverables, and timelines.
- Coordinate the preparation and execution of regulatory submissions (IND/CTA, BLA/MAA, Amendments, Annual Reports, and Supplements/Variations, including:
- Organizing a kick-off meeting with authors/reviewers
- Identifying content and developing in collaboration with the regulatory team, regulatory strategy
- Review documents (batch records, SOPs, protocols and reports) related to manufacturing in support of submission preparation
- Manage communication with stakeholders and others as to the status and timelines
- Manage the review, adjudication, and approval process
- Archive regulatory submissions and correspondence as required
- Manage escalation of issues and resolution with management
- Project Management of regulatory activities, as required based on scope of project
- Support departmental initiatives, including special projects and training, and participate on the global regulatory teams, functional area and department meetings
- Attend relevant functional area team meetings, representing regulatory, and actively participate in project or partner teams, as required
- Other regulatory activities
B.S./B.A. in a biological or physical science discipline
- Minimum 2-4 years’ experience in Regulatory or related function such as Manufacturing, Quality Assurance or Quality Control in the pharmaceutical field
- General understanding of regulations and operating in a regulated environment
- Good verbal and written communication skills
- Good attention to detail and ability to manage multiple ongoing projects
- Problem solving ability
- Outstanding interpersonal and communication skills (written and verbal) is required
- Proficient with computer and standard software programs.
We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.