Job Details

Associate Director/Director Regulatory Affairs

We are seeking an experienced regulatory affairs professional to drive regulatory strategy and execution across early stage programs. This role will report into senior leadership and serve as both a strategic partner and hands-on contributor, with a strong focus on CMC while maintaining a broad regulatory perspective. This is an opportunity to join an exciting start-up biotech in a high-visibility, high-impact role.

Associate Director / director, Regulatory Affairs - SF Bay Area 2-3 days/week hybrid

Base pay range

$190,000.00/yr - $250,000.00/yr

Responsibilities

• Develop and implement regulatory strategies to support global development programs from early phases through registration.
• Lead preparation, submission, and maintenance of regulatory filings (e.g., INDs, CTAs, BLAs, MAAs).
• Provide CMC-focused regulatory guidance while also contributing to clinical and nonclinical regulatory activities.
• Serve as the regulatory representative on cross-functional project teams, ensuring compliance and advancing program milestones.
• Draft, review, and finalize responses to health authority queries; participate in regulatory interactions.
• Stay current on global regulatory requirements and communicate implications to internal stakeholders.

Qualifications

• Advanced degree in life sciences or related field preferred.
• 8–10+ years of regulatory affairs experience in biotech/pharma; biologics and oncology/hematology experience strongly preferred.
• Proven track record in regulatory submissions and approvals, with expertise in CMC and early development.
• Strong knowledge of FDA, EMA, and ICH regulations; experience with global agency interactions.
• Excellent communication, project management, and cross-functional leadership skills.

If interested, please reach out to ...@meetlifesciences.com.

Job details

• Seniority level: Director
• Employment type: Full-time
• Job function: Science and Research
• Industries: Biotechnology Research and Pharmaceutical Manufacturing

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