Job Description

This is great opportunity to join a real future star in the Biotech & ATMP sector!  What makes this role and the company unique is the size of the pipeline (10 products in development) and its market capital (over $3Billion) for a company that is still only 10 years old. They have a number of Monoclonal Antibody products (4) already registered/approved globally and have a pipeline of 7 Gene products through various stages of development.

The Gene Therapy HQ is based in Boston, Massachusetts, but they are happy with this role to be remote.

Executive Director, Regulatory CMC Gene Therapy *** East Coast or Remote *** Lead the Preparation of 3 BLA’s planned in the next 24 months.

My client is looking for someone rare and unique, someone with experience in Cell or Gene Therapy Development and/or BLA’s, who would be happy to lead from the front as the Executive Director, Regulatory CMC reporting directly into the SVP of Global regulatory Affairs. This role has multiple compelling elements.  You will lead, manage and grow your team and you will also help them to prepare for 3 Gene Therapy BLA’s planned in the next 24 months.  It’s a big job, but the resources and capabilities are already in place.  You will have a strong team of Directors and Senior Directors, all with a background in Regulatory CMC within Gene Therapy. The regulatory leadership team is confident but friendly, who all have experience of working on successful BLA’s, and the company is in a strong financial position, with a number of biological products already on the market, and strong cash reserves in place.

Role:

As the lead member of the Regulatory CMC team for Gene therapy you will manage a team to oversee the preparation, review and filing of CMC sections of regulatory submissions (INDs, BLAs, CTA, MAAs, etc) and interactions with regulatory agencies and develop the CMC regulatory strategies and manage related regulatory activities for a portfolio of Gene Therapy products. You will ensure that all CMC regulatory goals are clearly defined, and they align with current industry standards and regulatory requirements and also provide significant input on applicable regulatory affairs processes, procedures, and tools to facilitate effective execution by the regulatory function across the organization.

Ideally you will be experienced in communicating regulatory strategy, submission documents and plans both internally and externally and can coordinate and prioritize multiple projects in a fast-paced, deadline driven start-up environment. Strong collaboration, teamwork, organizational skills and attention to detail are essential, as is a positive attitude and approach to people management.

On offer is a package that includes an exceptional base salary, high level bonus, and a generous/excellent LTi plan that includes options and RSU’s.

Qualifications:

• BA/BS in a scientific field of study with 15 years + of relevant experience working in Regulatory in the pharmaceutical/ biotech industry, including gene therapy experience.
• Strong knowledge, experience and leadership in interpretation of regulations and guidelines related to biologics drug development.
• Proven ability to analyze and organize information logically.
• In depth understanding and application of industry standards and international regulations and guidelines.

To Apply!

To apply for this role, please press the red “Apply for position” button, or contact me, Theo Moore, on US 908-348-6714. I will support you throughout the interview and on-boarding experience.

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