Associate Director/Director Regulatory GRL Nonclin/Clin

Location:  San Rafael, California Category: Regulatory

Description

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’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.

Summary

The Reg Nonclinical / Clinical (RNC) Global Regulatory Lead (GRL) Director / Associate 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. The RNC GRL will lead the Global Regulatory Team and the preparation of Nonclinical / Clinical documentation to support global regulatory filings. The RNC GRL will ensure global Health Authority interactions are planned and executed in line with the GRP; that input is adequately incorporated into program plans; and may act as the key liaison with Health Authorities. The RNC GRL is 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.   The RNC GRL ensures timely, effective communication between the Global Regulatory Team, Reg Leadership, Core teams, partner teams, and Senior management.   The RNC GRL role includes leading the generation of the Global Regulatory Plan (GRP), works with regional/functional leads to create global submission plans and ensures compliance with Agency requirements and commitments globally. 

The RNC GRL is viewed as a subject matter expert; will be a member of the cross functional Core Team; and is the point person to represent the global regulatory strategy for the program internally across all levels of the company, and externally to advisors, service providers, business partners and other collaborators.  

 

Responsibilities

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 cross functional departments as appropriate (Clinical Sciences, Medical Affairs, Commercial, pharmacovigilance, technical operations, Regional Regulatory Leads, etc.).
  • Lead strategic development/execution of life-cycle management activities and ensure compliance with approved licenses, and fulfillment of postmarking commitments/requirements globally, ensure maintenance reports are completed and submitted per country requirements.
  • Work with the regional/functional lead for the creation of global regulatory submissions and plans for heath authority interactions as defined in the GRP (e.g., CTAs, MAs, variations/supplements, annual reports, ODD, response to questions, expedited review requests, etc.)
  • 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 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 product life-cycle management activities.

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

  • 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

 

  • IND/CTAs:
    • 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 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

Commercial Stage Products

  • Serve as the RNC representative on the Global Regulatory Team
  • Maintain Core/Global Dossier through completion of nonclinical/clinical studies; facilitate core/global dossier updates with SMEs as needed based on regional submission requirements
  • Serve as an advisor/reviewer of content for INTL agency meetings and submissions (i.e., ODDs, MAs, RTQs), and MA maintenance (i.e., amendments, renewals, PMCs, safety reporting etc.)
  • Serve as reviewer of responses and any novel nonclinical/clinical content related to INTL submissions
  • Continue to serve as the regulatory representative on the CDT and MAPT.
  • Ensure fulfillment of global clinical and nonclinical PMRs/PMCs, including timely and effective communication of HA feedback (post-marketing study expectations and commitments/milestones) to relevant partner teams and the GRT; liaise with regional (EU/INTL) stakeholders on the global PMR fulfillment status and any relevant HA feedback, as appropriate
  • Lead submission of post-approval reports
  • Maintain US FDA product license and related amendments
  • Facilitate US clinical trial results postings on CT.gov.

Cross Functional

  • Serve as the GRL and lead 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
  • 6 + year experience with PhD; 8+ years with Masters or bachelor’s degrees
  • Nonclinical / Clinical Regulatory Affairs experience preferred
  • 2 or more years of line management experience preferred

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.