Senior Regulatory Affairs Manager

Direct message the job poster from GForce Life Sciences

Must be able to work on a W2

• 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, ensuring alignment with the Clinical Development Plan (CDP), nonclinical development plan, and regional regulatory input.
• Provide strategic insight to the GRT and serve as the Regulatory contributor to partner teams as appropriate.
• Ensure that feedback from global Health Authorities is incorporated into the global nonclinical and clinical development strategy in collaboration with regional regulatory representatives.
• Develop the global pediatric strategy and collaborate with regional leads on regional pediatric plans; ensure alignment with the Global Regulatory Plan and assess impacts of CDP or nonclinical plan changes.
• Lead or support strategy for life‑cycle expansion opportunities.

• Act as a key contributor to the Clinical and Nonclinical Development Plans, ensuring consideration of global health authority precedents and regulatory guidance.
• Provide proactive and reactive strategic input and regulatory expertise for the design and conduct of clinical and nonclinical studies.
• Contribute to the scientific interpretation and integration of clinical and nonclinical study results.
• Review and comment on company-sponsored abstracts, manuscripts, publications of original research, and press releases as requested.
• Coordinate provision of resources from Regulatory functions in support of clinical studies.

• Lead planning and preparation of clinical and nonclinical strategy and content for global Health Authority meetings, including briefing books, presentations, and Q&A strategy maps.
• Lead clinical and nonclinical FDA interactions in alignment with corporate or program goals.
• Serve as the point of contact for FDA regarding nonclinical/clinical communications.
• Ensure incorporation of global Health Authority feedback into clinical and nonclinical development programs.

• Ensure that clinical and nonclinical content is adequately presented in submissions supporting clinical trial applications and product approvals.
• Oversee CROs or vendors performing regulatory activities related to submissions and Health Authority interactions.

• Lead planning and preparation of core clinical and nonclinical content for global clinical trial applications.
• Lead collaboration with CROs to support global clinical trials.
• Coordinate global maintenance of IND/CTAs through clinical trial completion.
• Serve as the lead for nonclinical/clinical aspects of US FDA IND submissions.
• Partner with regional representatives to confirm CTA requirements.
• Maintain IND/CTAs through the end of clinical studies.
• Facilitate US clinical trial results postings on Clinical Trials.gov.

• Lead creation of the clinical and nonclinical content of the core CTD/global dossier for global marketing applications.
• Serve as regulatory lead on the Marketing Application Filing Team through preparation, submission, review, and approval.
• Serve as the lead for nonclinical/clinical aspects of US marketing applications, maintaining the US license and ensuring fulfillment of PMRs/PMCs.

• Degree in health or life sciences, including chemistry, molecular biology, or similar (PhD preferred; Master’s/Bachelor’s acceptable with relevant experience).
• 6+ years of experience with a PhD; or 8+ years with a Master’s or Bachelor’s degree.
• Nonclinical/Clinical Regulatory Affairs experience preferred.

Mid‑Senior level

Contract

Product Management, Other, and Strategy/Planning

Biotechnology Research and Pharmaceutical Manufacturing