Executive Director, Regulatory Science
2 days ago
We are seeking an experienced Executive Director in Regulatory Science to lead our Regulatory CMC group and provide strategic leadership to support multiple gene therapy programs. As a senior member of our team, you will be responsible for developing innovative CMC regulatory strategies and preparing high-quality CMC sections of INDs and CTAs.
Key Responsibilities- Develop and manage the Regulatory CMC group, ensuring effective collaboration with regulatory team members, CMC and Quality teams, contract manufacturing organizations, and external experts.
- Lead the development of CMC regulatory strategies for all Tessera development programs, anticipating phase-appropriate and future commercial requirements.
- Communicate CMC regulatory program strategies with functional heads and executive team members, ensuring alignment and buy-in.
- Lead discussions with regulatory agencies to resolve CMC issues and shepherd proactive interactions with regulators globally to refine CMC development strategies.
- Oversee planning, preparation, and submission of high-quality regulatory CMC dossiers, requiring a good understanding of the underlying science.
- Provide regulatory CMC guidance to internal teams and lead cross-functional teams to prepare briefing packages, Module 3 and 2.3 sections for INDs and equivalent IMPD sections for CTAs.
- Assess the regulatory impact of proposed manufacturing process changes and track regulatory CMC commitments.
- Manage on-going regulatory submissions and future reporting requirements, including annual reports.
- Effectively build, maintain, and motivate a high-performing regulatory CMC team, including hiring, developing, coaching, and mentoring a diverse, talented, and driven staff.
- Maintain knowledge of the global regulatory CMC environment and applicable regulations and guidelines, leading reg-CMC intelligence activities.
- Support Quality and CMC teams during GMP inspections.
You are an experienced Executive Director in Regulatory Science with specialized experience in Chemistry Manufacturing and Controls (CMC) for biologics. You are excited about being responsible for the development and management of the Regulatory CMC group and providing regulatory CMC strategic leadership to support multiple gene therapy programs, both in the US and internationally.
As a senior member of our team, you will be responsible for leading the development of innovative CMC regulatory strategies and the preparation and submission of high-quality CMC sections of INDs and CTAs, in close collaboration with regulatory team members, our in-house CMC and Quality teams, contract manufacturing organizations, external experts, and global health authorities.
At Tessera, you will find a highly collaborative, matrixed environment defined by rapid scientific innovation and a mission-driven culture dedicated to transforming the lives of patients with devastating genetic diseases.
You will make our mission possible by implementing state-of-the-art approaches to achieve operational excellence, optimize clinical trial efficiency, and accelerate the development of our gene therapies.
Tessera leaders are empathetic and transparent coaches with a strong sense of integrity. They are committed to the growth and development of their teams, the organization, and themselves.
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