Director / Senior. Director, Regulatory Affairs and Quality Assurance

Position Description:

Generation Bio is seeking a motivated, flexible and strategic individual to lead the Regulatory Affairs and Quality Assurance function. This is a highly visible and collaborative role that will shape the company regulatory and quality strategy on our path to patients.  He/she will be responsible for all quality and regulatory aspects of preclinical, CMC, and clinical drug development. From a regulatory perspective, this includes developing and executing a comprehensive and strategic, patient-centered regulatory plan, as well as highlighting risks and opportunities to the senior leadership team. This includes the technical and medical writing responsibilities to ensure timely preparation, review and submission of clear and concise clinical and regulatory documents in compliance with applicable requirements. Exhibit a strong leadership presence and a comprehensive understanding of global RA and QA regulations and guidelines. Utilize interpersonal skills and in-depth RA QA knowledge to establish corporate quality systems, supportive policies, and procedures that ensure Generation Bio's compliance with GxP regulatory requirements and adapting regulatory expectations. Additionally, contribute to fostering a robust Quality Culture within the organization.

The ideal candidate is a senior leader with both regulatory and quality experience who has a deep understanding of the regulatory pathways for siRNA and LNP therapies in the US and Europe.

Primary Responsibilities:

• Lead all aspects of regulatory and medical writing, including regulatory strategy, regulatory CMC, regulatory intelligence and regulatory operations, utilizing consultants and outsourcing vendors as appropriate
• Lead all aspects of quality assurance and quality control, including establishing phase appropriate Quality systems and SOPs to ensure compliance across all GxP areas of the company: GLP, GMP, GCP, GVP, utilizing consultants and outsourcing vendors as appropriate
• Establish and maintain effective professional relationships with FDA and global health authorities; including facilitating, negotiating and resolving regulatory and quality issues as needed
• Serve as the Regulatory and Quality Affairs representative on cross-functional steering teams, such as the Development Team and the Specifications Committee
• Author and/or review regulatory submissions such as INDs / CTAs, meeting requests, briefing documents and responses to Health Authority questions
• Provide regulatory oversight of program documents including target product profiles, development plans, and non-clinical and clinical protocols and reports
• Support or lead Due Diligence activities as appropriate

Preferred Qualifications:

• B.S./B.A required; advanced degree preferred (M.S., Ph.D., PharmD or equivalent) in a relevant scientific discipline with a minimum of 12 years of relevant Regulatory Affairs and/or Quality Assurance experience in the biotech industry
• Direct experience with regulatory health authority interactions and quality inspections for siRNA and LNP products
• Strong knowledge of cGMPs, FDA, EU GxP, ICH regulations
• Strong technological aptitude, with hands-on experience in regulated e-systems (e.g. Veeva)
• Strong verbal and written communication skills, detail-oriented, exceptionally organized, and ability to influence change across different stakeholder groups (internal and external)
• Must be a proven problem-solver, able to operate as both an individual contributor and a people manager to deliver on key objectives, demonstrating resilience and strategic thinking while being flexible.
• Proven ability to develop strong relationships with partners both internally and externally, fostering a collaborative and inclusive work environment.
• Demonstrated ability to mentor team members, fostering a positive and inclusive team culture that encourages growth and development.

Position: Full-Time, Exempt