Associate Director/Director Regulatory Operations
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 Operations function has a lead role in overall BioMarin Regulatory Submission planning, execution and submission system end user technical support. Specifically, this team develops and maintains submission processes, templates, standards, and guide sheets and will format, publish, transmit, track and archive all Regulatory submission types. This group will also provide training and complex system user issues involved in the preparation of materials for submission.
The Regulatory Operations Associate Director US is responsible for oversight of regional submission planning, including scheduling, resource allocation, formatting, QC, publishing, transmitting, and archiving regulatory submissions.
The Regulatory Operations Associate Director may have the role of Operations Lead for an assigned product 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, CA in addition to providing support to the AD UK for EU and Rest of World. In addition to the oversight of systems and technical support as needed.
The BioMarin Associate Director US is viewed as a subject matter expert in the functional area involved in developing, modifying and executing on product strategies and have a function-wide and may have a company-wide impact. The AD will typically collaborate, influence and negotiate with senior Regulatory leaders on product/program strategies and actions leveraging their advanced Regulatory Submission knowledge.
As the Regulatory Operations Regional Lead, the Associate Director will be responsible for:
Team Leadership and Management
- Create a cohesive, balanced and high functioning team focused on producing high quality deliverables and outcomes
- Optimize allocation of team resources across initiatives
- Lead recruiting, hiring, promotions and team management efforts, in collaboration with HR and functional head, for all Regulatory Operations staff across products in assigned region
- Mentor and guide Regulatory Operations staff on BioMarin career development
Regulatory Operations Regional Leadership
- Responsible for leading strategy for assigned region across Regulatory Operations team; critically involved in the programs and provides leads with guidance on strategic direction
- Oversee and guide, as needed, Regulatory Operations team deliverables and activities for assigned region
- Communicate policy priorities to BioMarin leadership as appropriate
- Oversight of relevant position statements, comment letters, and ensuring outputs are aligned with company positioning
- Be the expert on relevant guidance documents to advise senior management on strategic approaches for regulatory strategy
- Manage and resolve escalated issues and/or user support trouble shooting within assigned scope; mitigate relevant regulatory risks and identify opportunities
- Participate in Regulatory Operations process and business improvement initiatives
- Collaborate with Regulatory Operations Regional leads to ensure global SMEs engagement, when required
As the Regulatory Operations Program/Product Lead for a complex or high profile program, the Associate Director will be responsible for:
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
Education & Experience
- Degree in health or life sciences, including chemistry, molecular biology, or similar. PhD preferred, Masters/Bachelors acceptable with relevant experience
- 5 + year experience with PhD; 8+ years with Masters, 10+ with bachelor’s degrees
- Regulatory Operations / Regulatory Submission experience preferred
- 2 + 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.