Executive Director Reg Affairs - hybrid SF

We are a clinical-stage biotechnology company with a strong commitment to advancing potentially curative therapies for heart disease by addressing its underlying causes. We are located in San Francisco, California, USA, and our dedicated team consists of over 140 professionals.

Responsibilities:

• Develop and execute global regulatory strategies and act as an influential leader within the organization, offering regulatory expertise.
• Prepare and review regulatory submissions, ensuring accuracy and alignment with our global regulatory strategies.
• Lead or contribute to cross-functional initiatives, collaborating closely with teams in clinical, manufacturing, quality, and program management, while also developing best practices as needed.
• Provide guidance and growth opportunities for team members in Regulatory Affairs, both direct and indirect reports. Oversee the activities of regulatory consultants.
• Offer regulatory support for clinical operations activities, including the review of essential documents and the development and review of consent forms.
• Participate in the review of educational materials.
• Keep management, including executives, informed with regular updates.
• Support business development activities by supplying regulatory expertise and conducting due diligence assessments.
• Guide and make decisions regarding global regulatory strategy for clinical and approval objectives at Core and Project team meetings.
• Maintain direct and/or indirect interactions with US and ex-US Health Authorities.
• Manage clinical trial applications in EU/ROW, prepare meeting requests, and create briefing packages.
• Serve as the primary contact for Regulatory Agencies, representing the company in meetings and negotiations.
• Stay vigilant about changes in regulatory requirements and emerging regulations, proactively identifying opportunities and potential challenges for our gene therapy products.
• Ensure the company's compliance with relevant global regulatory requirements and provide support for regulatory inspections and audits.
• Cultivate and maintain relationships with key stakeholders, including regulatory authorities, external partners, and industry associations.

Requirements:

• Minimum of a BS/BA degree, with an advanced (MS, PhD, or PharmD) degree preferred.
• Ex-US experience is highly desirable.
• A minimum of 12 years of experience in regulatory affairs, including gene therapy, with at least 5 years in a leadership role.
• Willingness to work on-site weekly within a local hybrid model.
• Demonstrated success with multiple regulatory submissions and approvals (IND, NDA, BLA, MAA, CTAs, JNDA, etc.) in the gene therapy field.
• Proven ability to work both independently and as part of a team, effectively collaborating with various functional groups.
• An adaptable and phase-appropriate mindset.
• In-depth knowledge of global regulatory requirements and guidelines, including FDA, EMA, and other relevant authorities.
• The ability to thrive in a fast-paced, dynamic environment and adapt to changing priorities.
• A strong commitment to the highest ethical standards and scientific rigor.
• Exceptional attention to detail, and proficiency with Microsoft Office applications, Adobe, and Starting Point document templates.

Posted on Oct 31, 2023.

Employer-provided

Pay range in San Francisco Bay Area

Exact compensation may vary based on skills, experience, and location.

Base salary

$275,000/yr - $325,000/yr