Director, Regulatory GRLLocation 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 Reg Nonclinical / Clinical Director will lead, conceive, communicate and execute upon the global clinical and nonclinical regulatory strategies throughout a program’s lifecycle that are in alignment with corporate goals and timelines. 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. A Director may also lead the Global Regulatory Team for a development program and be a member of the cross functional Core Development team.
The BioMarin Director will typically have the opportunity to lead the development of strategic objectives that are subject to senior management approval and make final decisions on administrative and operational matters to ensure effective achievement of objectives. The Director will be expected to work on issues where in-depth knowledge and data analysis are required to support and influence leaders on matters of significance for the product and function.
Development Stage Products
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.
- Incorporate RA INTL guidance on development programs (i.e., INTL requirements or policies that may impact clinical development and commercialization).
- Develop global pediatric strategy; collaborate with regional leads on the content for regional pediatric plans (e.g., PIP); 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.
Clinical and Nonclinical Development Plan Advancement
- Act as a key contributor/stakeholder 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.
- Ensure that global HA feedback is incorporated into the clinical and nonclinical aspects of the development programs.
- 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.
Regulatory Submissions and related activities
- Broadly, ensure that the clinical and nonclinical content is adequately presented in submissions leading to successful clinical trial applications and product approvals.
- Oversee any CRO/vendors that are contracted to perform any of the regulatory activities related regulatory submissions and HA interactions
- Lead planning and preparation of core clinical and nonclinical content for global clinical trial applications, collaborating with SMEs and regional regulatory representatives.
- Lead collaboration with CROs to support global clinical trials in line with corporate goals.
- Coordinate maintenance of IND/CTAs globally through clinical trial completion.
- Directly responsible for nonclinical/clinical aspects of US FDA IND submissions.
- Partner with regional regulatory representatives to confirm CTA requirements as needed (i.e., confirm information provided by CROs)
- Marketing Applications (MAs):
- Lead the creation of the clinical and nonclinical content of core CTD / global dossier for use in global marketing applications, collaborating with SMEs and regional regulatory representatives.
- Serve as RNC lead on MA Filing Team to support original MA preparation (typically FDA/EMA), submission, review through approvals
- Directly responsible for nonclinical/clinical aspects of US marketing applications
- During US and EU application review process:
- Collaborate with SMEs and regional regulatory leads to determine strategy for responses, author responses, and review responses drafted by SMEs.
- Collaborate with labeling to support nonclinical / clinical Labeling content negotiations with HA
- Lead development of nonclinical / clinical regulatory strategy for post marketing studies in partnership with SMEs and regional regulatory representatives; collaborate with INTL/EU to ensure aligned approach to global post marketing negotiation
- Transition to INTL to drive commercialization post-US/EU MA approvals
- Update core dossier post-US/EU MA approvals for use in INTL filings
- Provide overview of core dossier and summary of FDA/EMA review issues to INTL representatives as part of transition process
- Provide available nonclinical/clinical documents (i.e., ODD, BBs, FDA/EMA mtg minutes, RTQs etc…)
- Participate and advise MA Filing Teams focused on INTL MA as SME
- Serve as the RNC representative on the Global Regulatory Team
- Work with REG-PM to establish and maintain project timelines.
- Serve as RNC liaison on WWRD partner teams (or delegate representation) (i.e., RPT, CDT, SET, MAPt teams) to advise on nonclinical/clinical regulations/requirements; ensure submission priorities are aligned and regulatory strategy is clearly defined; and goals are achieved, and communications are shared to/from the GRT. If RNC is not the GRL, RNC may participate in Core Team when invited by the GRL on an agenda driven basis.
Education & Experience
- Degree in health or life sciences, including chemistry, molecular biology, or similar. PhD preferred, Masters/Bachelors acceptable with relevant experience
- 7 + year experience with PhD; 10+ years with Masters or bachelor’s degrees
- Nonclinical / Clinical Regulatory Affairs experience preferred
- 3 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.