Senior Manager, Regulatory OperationsLocation San Rafael, California Workstyle Open to Hybrid 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.
The Regulatory Operations Senior Manager may have the role of Operations Lead for an assigned product/program and oversee submission planning, including scheduling, resource allocation, formatting, QC, publishing, transmitting, and archiving regulatory submissions in both paper and electronic media to health authorities in the US, EU, CA and Rest of World. In addition to the oversight of systems and technical support as needed.
The BioMarin Senior Manager will support leadership in the development of Regulatory 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 Regulatory submission knowledge, understanding of industry trends and analytical ability to develop options and solutions for presentation to, and approval by, senior leadership.
Submission Planning Leadership and Communication
- Oversee the development and maintenance of processes, templates, standards, and guide sheets
- Independently format, publish, transmit and archive all submission types; maintain templates
- Track status of submissions and project assignments; provide status updates and other communications to Regulatory Operations Management
- Manage timelines for submission calendar
- Participate in GRT and related sub-team meetings as needed and ensure adequate follow-up
- Oversee applications and systems support, systems training programs, and supporting development projects within Regulatory Affairs
- Trouble shoot complex system user issues (such as interpreting technical validation errors)
People Development (for management track)
- Manage internal Regulatory Operations personnel as well as the activities of external consultants.
- Foster a culture that promotes respect, teamwork, collaboration, openness, and appreciation
- Mentor junior Regulatory Operations team members to build collaborative and effective working relationships and promote professional growth and the development of high-quality deliverables
- Stay abreast of new guidances released by health agencies and coach team members on interpretation as needed
- Perform regulatory intelligence for information pertinent to Regulatory Operations and provide a preliminary assessment of impact of new or modified regulations and guidances
- Support due diligence activities and audits when necessary
- Must be highly proficient in MS Office 365 (with an emphasis on MS Word)
- Experience with Adobe Acrobat (version XI Pro or DC preferred) and publishing related plugins such as ISI Toolbox
- Strong knowledge of eDMS and eCTD Publishing Systems (VEEVA RIM) and InSight Publisher preferred).
- Must have extensive experience with electronic submissions, specifically eCTD
Experience & Education
- Degree in health or life sciences, including chemistry, molecular biology, or similar. PhD preferred, Masters/Bachelors acceptable with relevant experience
- 2 + year experience with PhD; 4+ years with Masters, 6+ with bachelor’s degrees
- Must have extensive experience with electronic submissions, specifically eCTD.
- 0-1 + years 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.
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.