Director/Senior Director GRL, Regulatory Affairs
Who We Are
From research and discovery to post-market clinical development, our WWRD engine 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 genetic diseases.
BioMarin Global Regulatory Affairs (GRA) is responsible for obtaining approval for new BioMarin products and ensuring that approval is maintained throughout the product lifecycle. GRA serves as the interface between the regulatory authorities and the program teams aiming to ensure that the project plan correctly anticipates what the regulatory authority will require before approving the product. It is the responsibility of GRA to keep abreast of current legislation, policies, guidelines and other regulatory intelligence. The RA department plays an important role in giving advice to the program teams on how best to interpret the regulatory legislation and guidelines.
BioMarin Regulatory Affairs Nonclinical / Clinical (RNC) team plays a key role in defining the BioMarin regulatory strategy and pathway for a product by leading the development and execution of the nonclinical / clinical regulatory strategy and plan in alignment the overall clinical development plan. This team will take a lead role in planning and developing relevant sections of regulatory filings required for product approvals. In addition, this team will lead planning, coordinating and engaging directly with Health Authorities before, during and after regulatory approval milestones.
The RNC Director/Senior Director is the Global Regulatory Leader (GRL) responsible for oversight and management of all nonclinical and clinical regulatory strategy development (including global market and life-cycle expansion opportunities), and activities related to HA interactions and regulatory submissions for a gene therapy product. This includes formulating the global Nonclinical / Clinical strategy for the Global Regulatory Plan, acting as the key liaison with Health Authorities and leading the preparation of Nonclinical / Clinical documentation to support global regulatory filings. The GRL will lead the Global Regulatory Team (GRT) for the program, and serve as a key member of the cross functional Core Development Team. May manage 1-2 direct reports
Regulatory Strategy Development
- Lead the development, integration, execution and maintenance of the global nonclinical and clinical regulatory strategy for the Global Regulatory Plan (GRP) throughout the product lifecycle. Ensure strategic alignment with the Clinical Development Plan (CDP) and nonclinical development plan with input from clinical and nonclinical Subject Matter Experts (SMEs), respectively, and regional regulatory leads.
- In collaboration with regional regulatory representatives, ensure that feedback from global Health Authorities is incorporated into the global nonclinical and clinical development strategy.
- Develop global pediatric strategy; collaborate with regional leads on the content for regional pediatric plans; ensure global pediatric strategy is reflected in the Global Regulatory Plan; ensure any changes to CDP or Nonclinical development plans are assessed by regional leads for impact to pediatric plan agreements with Health Authorities.
- Expand knowledge base of laws, regulations, and guidelines governing the development, licensure, and marketing of drugs, biologics, and companion diagnostics
Clinical and Nonclinical Development Plan Advancement
- Act as a key contributor to the Clinical and Nonclinical Development Plans and ensure that they incorporate consideration of current global health authority precedents and regulatory guidance.
- Provide both proactive and reactive strategic input and regulatory expertise in the design and conduct of clinical and nonclinical studies
- Contribute critically to the scientific interpretation and integration of clinical and nonclinical study results.
- Review and provide comments on all company sponsored abstracts, manuscripts and publications of original research and press-releases, as requested.
- In collaboration with Regulatory Affairs functional management, coordinate the provision of resources from the various Regulatory functions in support of clinical studies.
Health Authority Meetings
- Lead planning and preparation of the clinical and nonclinical strategy and content for global HA meetings, working closely with SMEs and regional regulatory leads. Deliverables include core content for the briefing book, presentation, and the Q&A strategy map.
- Lead clinical and nonclinical FDA interactions in alignment with corporate and/or program goals.
- Serve as the point of contact for FDA regarding nonclinical/clinical communications.
- Ensure that global HA feedback is incorporated into the clinical and nonclinical aspects of the development programs.
Regulatory Submissions and related activities
- Oversee the preparation, submission, and management of global regulatory submissions (ie, IND/CTA, Supplements, global MAs, and LCM expansion activities)
- management of global regulatory submissions (ie, IND/CTA, Supplements, global MAs, and LCM expansion activities)
- Oversee any CRO/vendors that are contracted to perform any of the regulatory activities related regulatory submissions and HA interactions
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
- Proven track record of managing critical projects as a part of an interdisciplinary team
- Proven track record of representing the department in project teams, committees and external meetings
- Prior experience managing regulatory submissions to deadlines
- Thorough understanding of relevant drug development regulations and guidelines
- Outstanding interpersonal and communication (written and verbal) skills
- Effective task planning and coordination abilities
- Proficiency with computer and standard software programs (Microsoft Office, PowerPoint and Excel)
- Experience managing a small team or at a minimum management in a matrix setting
- Rare disease experience is desirable
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.