Sr. Director, Regulatory Affairs Portfolio LeadLocation 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.
The Senior Director Regulatory Nonclinical / Clinical will lead a team covering a portfolio of products focusing on oversight and management of all nonclinical and clinical regulatory strategy development and activities related to HA interactions and regulatory submissions across a portfolio of products. The Nonclinical / Clinical Senior Director will also manage and develop a high performing team. A Senior Director may also lead the Global Regulatory Team for a complex program and be a member of the cross functional Core Development team.
A Senior Director at BioMarin will have corporate wide impact from both an operational and strategic standpoint, setting strategies and being involved in developing organizational policies for the function. This will regularly provide the opportunity to influence peers and executives and serve as the organizational expert/spokesperson for the Reg Nonclinical / Clinical portfolio of products.
- Create a cohesive, balanced and high functioning team focused on producing high quality Regulatory deliverables and outcomes
- Optimize allocation of team resources across portfolio of products
- Lead recruiting, hiring, promotions and team management efforts, in collaboration with HR, for managed RNC staff
- Mentor and guide managed RNC staff on BioMarin career development
- Identify and advocate for training and tools in support of RNC skill development
- Contributes to the RNC budget for product portfolio
Regulatory Affairs Nonclinical / Clinical strategy and execution
- Oversee and guide the Regulatory Affairs nonclinical / clinical Global strategy and plan development across the product portfolio; ensure Global Regulatory Plans are high quality, comprehensive, and updated.
- Oversee the Health Authority interactions for products in the portfolio and ensure that global HA feedback is incorporated into the clinical and nonclinical aspects of the development programs.
- Oversee planning and preparation of core clinical and nonclinical content for global clinical trial applications
- Oversee governance of CROs to ensure effectiveness
- Oversee planning and preparation of core clinical and nonclinical content for global marketing applications
- Oversee the filing and review of US marketing applications and support GRT on content and execution for global HA meetings
- Play leadership role in preparing for FDA Advisory Committee meetings.
- Oversee the creation of the clinical and nonclinical content of core CTD / global dossier for use in global marketing applications
- Oversee maintenance of nonclinical/clinical aspects of approved US product licenses, including regulatory activities related to global post-marketing clinical studies
- Manage and resolve escalated issues; mitigate product risks and identify opportunities affecting the RNC activities
- Ensure RNC processes and procedures are carried out in a compliant and consistent manner according to published guidelines
- Advocate, collaborate, facilitate and drive RNC synergy and best practice sharing across Global Regulatory Affairs functions and relevant BioMarin cross-functional stakeholders
- Collaborate with heads of key stakeholder functional areas (e.g., Development Sciences, Medical Affairs, Commercial) to build strategic alignment, collaboration, and information sharing
- Lead, or participate in, key Regulatory Affairs strategic, change or improvement initiatives
Education & Experience
- Degree in health or life sciences, including chemistry, molecular biology, or similar. PhD preferred, Masters/Bachelors acceptable with relevant experience
- 8 + year experience with PhD; 10+ years with Masters or bachelor’s degrees
- Nonclinical / Clinical Regulatory Affairs experience preferred
- 4 or more 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.