Associate Director, Regulatory Affairs
Location
San Rafael, CA | United States
Job description
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.
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.
- Provide strategic insight to the GRT regarding product development, and serve as Regulatory contributor to partner teams (eg, study execution teams, clinical development team etc.) as appropriate
- 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.
- Lead/support strategy for life-cycle expansion opportunities
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.
Skills
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)
- Maintain IND/CTAs through end of clinical studies
- Facilitate US clinical trial results postings on CT.gov
- 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 global MA preparation, submission, review through approvals
Directly responsible for nonclinical/clinical aspects of US marketing applications, maintaining US license and ensuring fulfillment of any PMRs/PMCs
Education
- 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
Equal Opportunity Employer/Veterans/Disabled
An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
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