Senior Director, Regulatory Science (CMC)

Your experience includes… 

• Ph.D. and 12+ years of relevant biopharmaceutical industry experience, or M.S. with 15+ years of experience.
• At least 5 years of experience in CMC‐focused regulatory science role, preferably for the development of gene therapies, oligonucleotides, or biologics.
• 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).
• Well-versed in regulatory and technical writing.
• Retains optimism and energy in the face of change and challenges; eagerness to problem solve and influence outcomes.
• Ability to incorporate multiple viewpoints to create optimal strategy forward.
• Independently motivated, detail oriented and scientifically rigorous.
• 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; experience in projects involving scale-up, comparability, and expedited pathways is considered a plus.

You are interested in…  

• Developing robust CMC regulatory strategies for all Tessera's development programs, anticipating phase-appropriate and future commercial requirements, in close collaboration with Technical Operations and Quality colleagues.
• Leading discussions with regulatory agencies to resolve CMC issues as well as shepherding proactive interactions with regulators globally to refine CMC development strategies.
• Overseeing 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 lead 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 participating 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. 
• Supporting Quality and CMC teams during GMP inspections.
  
  

About you: 

You are an experienced Senior Director in Regulatory Science, specialized in Chemistry Manufacturing and Control (CMC) for biologics who is interested in being responsible for the development and management of the regulatory CMC strategy for multiple gene therapy programs that are in the early stages of development. You are excited about 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. You are a driven individual who is comfortable multitasking and working independently, and are ready to join a dynamic, rapidly growing, and highly collaborative team.

Tessera employees are creative and collaborative problem solvers. They have a strong sense of integrity and unwavering commitment to scientific excellence. 

 

Meet your Manager:

All inquiries regarding the posted position should be directed to the Talent Partner (see below). Interested individuals must apply directly to be considered for the opening.

Meet your Manager:

Narin Ahmed, Vice President, Regulatory Science

 

Meet your Talent Partner: