Director of Regulatory Affairs

Director of Regulatory AffairsI 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 ResponsibilitiesProvide 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 ExpectationsEstablish 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 BackgroundBachelor'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.Notes2/3 days a week onsite in South San FranciscoSponsorship potentially available Charman@ - 919 647 9154

Created: 2025-02-15