Job Description

Sr. Regulatory Affairs Manager (Nonclinical / Clinical)

Duration: 12 Month Assignment – potential to extend / convert)

Location: San Rafael, CA (Open to Remote)

Pay: $78-80 / HR

Overview:

A leading biotechnology organization focused on developing therapies for rare and life-threatening genetic conditions is seeking a Sr. Regulatory Affairs Manager to join the Global Regulatory Affairs (GRA) team. This group is responsible for securing regulatory approvals for new products and maintaining them throughout the lifecycle, serving as the strategic interface between internal program teams and global health authorities.

This role supports the Nonclinical / Clinical Regulatory Affairs function, shaping global regulatory strategies and leading key submissions across the product lifecycle.

Key Responsibilities

Regulatory Strategy Development

• Lead the development, integration, and execution of global nonclinical and clinical regulatory strategies.
• Ensure alignment between the Global Regulatory Plan (GRP), Clinical Development Plan (CDP), and nonclinical strategy.
• Collaborate with regional regulatory leads to incorporate global Health Authority feedback.
• Develop global pediatric strategy and support regional pediatric plan submissions.
• Provide strategic insights across clinical and nonclinical program teams.

Clinical & Nonclinical Development Support

• Advise on clinical and nonclinical study design in alignment with regulatory guidance.
• Assist in the scientific interpretation of study results.
• Review abstracts, manuscripts, publications, and press releases.
• Coordinate regulatory resources supporting clinical studies.

Health Authority Interactions

• Lead preparation for global Health Authority meetings, including briefing content and Q&A strategy.
• Serve as point of contact for FDA on nonclinical/clinical matters.
• Integrate global Health Authority feedback into development programs.

Regulatory Submissions

• Oversee clinical and nonclinical content for global submissions including INDs, CTAs, and marketing applications.
• Lead creation of core CTD modules and support global dossier development.
• Maintain IND/CTA filings through study completion.
• Ensure compliance with US regulatory requirements, including ClinicalTrials.gov postings.
• Manage CROs/vendors supporting regulatory activities.

Qualifications

• Degree in Life Sciences (PhD preferred; MS/BS accepted with relevant experience).
• 6+ years regulatory experience with PhD; 8+ years with Master’s or Bachelor’s.
• Direct experience in nonclinical/clinical regulatory strategy strongly preferred.
• Strong understanding of global regulatory frameworks and Health Authority expectations.
• Demonstrated ability to lead complex regulatory projects and influence senior stakeholders.

Please submit your resume in Word or PDF format to be considered.

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