Director, Regulatory Affairs

Enigma Search; South San Francisco (CA); Vor Ort; USD 150.000 - 200.000; Vollzeit

Zusammenfassung

Enigma Search is looking for a Director of Regulatory Affairs to spearhead regulatory strategies in South San Francisco. The ideal candidate will possess a Master’s degree in a life science discipline, with a preference for a PhD, along with at least 10 years in regulatory affairs.

This pivotal role includes developing strategies for first-in-class therapies and ensuring clear communication with global health authorities. The candidate should be self-motivated and thrive in a fast-paced environment, willing to work onsite at least four days a week.

Qualifikationen

• Minimum of 10 years of regulatory affairs experience in industry, academia, or clinical research.
• Experience in rare disease development and/or novel endpoints.
• Proven track record of developing regulatory submissions.

Aufgaben

• Develop and execute global regulatory strategies for assigned programs.
• Lead interactions with global health authorities.
• Oversee preparation and submission of regulatory applications.

Kenntnisse

Regulatory submission development

Knowledge of global regulations (FDA, EMA)

Strong communication skills

Problem-solving skills

Organizational skills

Collaboration

Ausbildung

Masters degree in a life science discipline

PhD preferred

Jobbeschreibung

About the job Director, Regulatory Affairs

Are you a seasoned Regulatory Affairs professional ready to make a significant impact on human health? We are seeking a strategic and driven Director of Regulatory Affairs to join a pioneering research and development company focused on extending healthy lifespan.

This is an exceptional opportunity to play a pivotal role in developing and implementing innovative regulatory strategies for groundbreaking programs. You will collaborate with cross-functional teams and external partners, driving regulatory success from IND-enabling studies through clinical proof-of-concept and beyond.

Your Impact:

• Develop and execute global regulatory strategies for assigned programs, including first-in-class therapies and programs with external partnerships.
• Lead interactions with global health authorities, preparing briefing packages and ensuring clear communication.
• Collaborate with executive leadership to define regulatory strategies aligned with the company's mission.
• Oversee the preparation and submission of regulatory applications, ensuring accuracy and timeliness.
• Develop effective CMC regulatory strategies in collaboration with Technical Operations.
• Provide strategic regulatory input to development teams, protocols, reports, and other critical documents.
• Stay ahead of global regulatory changes, communicating updates and developing proactive strategies.
• Collaborate with cross-functional teams and external consultants.

What You Bring:

• Masters degree in a life science discipline (PhD preferred).
• Minimum of 10 years of regulatory affairs experience in industry, academia, or clinical research, with experience in rare disease development and/or novel endpoints.
• Proven track record of developing regulatory submissions, including experience with major approvals (NDA, BLA, MAA, etc.).
• Strong knowledge of global regulations (FDA, EMA, etc.).
• Experience with mechanisms to expedite agency interactions.
• Advanced skills in creating and assessing regulatory proposals and leading health authority interactions.
• Excellent communication and influencing skills.
• Self-motivated, strategic thinker with strong problem-solving skills.
• Exceptional organizational and prioritization skills.
• Ability to thrive in a fast-paced, collaborative, start-up environment.
• Must be willing to work onsite at least four days per week.