Executive Director, Regulatory Science (CMC)

Your experience includes… 

• Master’s degree in biochemistry, chemistry, biology or related pharmaceutical fields including chemical engineering required, Ph.D. desirable.
• Minimum of 16 years of relevant biopharmaceutical industry experience with at least 5 years of experience in CMC‐focused regulatory science role.
• Recent experience in successfully leading CMC‐related regulatory interactions, and in IND/CTA or BLA/MAA regulatory submissions and approvals.
• Proven success in delivering effective global regulatory CMC strategies and in leading a regulatory CMC team.
• Excellent written and oral communication and interpersonal skills.
• Thorough understanding of CMC drugs and biologics regulations and guidelines including ICH, FDA and EMA guidelines. Strong knowledge of current Good Manufacturing Practices (GMP).
• Being well-versed in regulatory and technical writing.
• Retaining optimism and energy in the face of change and challenges; eagerness to problem‑solve and influence outcomes.
• The ability to incorporate multiple viewpoints to create optimal strategy forward.
• Being independently motivated, detail oriented and scientifically rigorous.
• Experience as a hands-on, roll-up-the-sleeves-when-necessary leader who understands the need for involvement within a growing company environment while recognizing when to delegate and empower the team.
• It's a bonus if you have:
  • Prior subject matter expertise and work experience in a CMC technical role to develop advanced therapy or biologics preferred such as gene therapies, oligonucleotides, or biologics.
  • Experience in projects involving scale-up, comparability, and expedited pathways.

You are interested in…  

• Developing robust CMC regulatory strategies for all Tessera development programs and anticipating phase-appropriate and future commercial requirements, in close collaboration with Technical Operations and Quality colleagues.
• Communicating CMC regulatory program strategies with functional heads and executive team members.
• Leading discussions with regulatory agencies to resolve CMC issues as well as shepherding proactive interactions with regulators globally to refine CMC development strategies.
• Oversee planning, preparation, and submission of high-quality regulatory CMC dossiers; this will require a good understanding of the underlying science.
• Providing regulatory CMC guidance to internal teams and leading cross-functional teams to prepare briefing packages, Module 3 and 2.3 sections for INDs and equivalent IMPD sections for CTAs.
• Assessing regulatory impact of proposed manufacturing process changes.
• Tracking regulatory CMC commitments; managing on-going regulatory submissions and future reporting requirements, including annual reports.
• Effectively building, maintaining, and motivating a high-performing regulatory CMC team- including hiring, developing, coaching, and mentoring a diverse, talented and driven staff.
• Actively participate in building an outstanding regulatory team, leveraging operational excellence to efficiently implement innovative regulatory strategies.
• Maintaining knowledge of global regulatory CMC environment and applicable regulations and guidelines. Leading reg-CMC intelligence activities.
• Support Quality and CMC teams during GMP inspections.

About you: 

You are an experienced Executive Director in Regulatory Science with specialized experience in Chemistry Manufacturing and Controls (CMC) for biologics who is excited about being responsible for the development and management of the Regulatory CMC group and for providing regulatory CMC strategic leadership to support multiple gene therapy programs, both in the US and internationally. As a senior member of the 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. 

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