Director, Regulatory Affairs

I am working with a innovative biotech company is seeking a Director of Regulatory Affairs to lead regulatory efforts for its clinical-stage programs.

This role requires a strategic regulatory leader to guide global regulatory strategies, ensuring alignment with clinical development objectives and future approvals. You will collaborate cross-functionally to navigate regulatory landscapes and drive the success of pivotal trials. Reporting to the VP of Regulatory & Quality, you will play a key role in interactions with regulatory agencies and internal stakeholders.
Key Responsibilities

• Provide strategic regulatory guidance to cross-functional teams, external partners, and consultants.
• Develop and execute regulatory strategies for clinical development programs, ensuring compliance with evolving requirements.
• Identify potential regulatory risks and develop proactive solutions to mitigate challenges.
• Monitor and interpret regulatory trends, applying insights to support program advancement.
• Lead and prepare teams for interactions with health authorities, ensuring well-structured meetings and submissions.
• Oversee the development, review, and finalization of high-quality regulatory documents.
• Support continuous improvement initiatives within the regulatory affairs function.

Leadership Expectations

As a director-level leader, you will be expected to demonstrate:

• Establish strong internal communication channels, influence senior leadership, and foster collaborative decision-making.
• Build partnerships across departments, proactively resolve conflicts, and promote teamwork.
• Identify operational gaps, clarify priorities, and address obstacles to program success.
• Empower teams, stay informed on industry trends, and cultivate an environment of continuous learning.

Ideal Background

• Bachelor's degree required; an advanced degree in life sciences is preferred.
• 10+ years of regulatory affairs experience, particularly in clinical-stage development.
• Strong knowledge of global regulatory requirements (ICH, FDA, EMA, etc.) and industry trends.
• Hands-on experience preparing regulatory submissions (IND/CTAs required; NDA/BLA/MAAs preferred).
• Proven ability to manage multiple projects, solve regulatory challenges, and drive timelines effectively.
• Strong organizational and communication skills, both written and verbal.
• Thrives in a fast-paced, small biotech setting with broad responsibilities.

Notes

• 2/3 days a week onsite in South San Francisco
• Sponsorship potentially available

This role offers the opportunity to make a meaningful impact on regulatory strategies and contribute to the development of transformative therapies.

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