Expiry Date: 31-08-2022
Categories Biotech, Regulatory Affairs
Salary: On Application
Job Type: Full Time
San Francisco County
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 their global HQ is based in California, but they are happy with this role to be remote.
Director Regulatory Affairs CMC *** California / Remote *** Global Regulatory CMC leadership Role
My client is looking for someone with a collaborative and team-oriented attitude, who can foster effective and positive interactions across functions, project teams, regulatory agencies, and corporate partners. This is a global role, which is an owner contributor position, but opportunities for management, mentoring and or team leading could be available in the future, as my client has a strong pipeline that continues to expand and thrive, and the regulatory teams continue to grow and grow.
As the Director Regulatory Affairs CMC, you will be responsible for managing the regulatory CMC aspects of assigned projects in early to late-stage development, as well as maintenance and life cycle management of globally marketed products.
This position will support and manage global regulatory activities associated with the Chemistry, Manufacturing and Controls for clinical and commercial products and provide input into the product strategy and to the direction provided to commercial and clinical teams.
You will be reporting into a strong and dedicated Senior Director who will be a support and guide for any future development opportunities that you may find attractive. The Regulatory Leadership team is well established and well respected, with many coming from the Top Ten Biotech companies in the California area.
We think this is a great role for a company with a strong pipeline, and great plans for expansion and we think this could be a unique opportunity to join a young Biotech with all the pieces in place to be a huge success.
On offer is a great overall package including a strong salary, exceptional bonus and a very generous LTi/stock options plan, and extremely generous benefits package. If you are based in California or the West Coast, this role can be remote!
BA/BS degree in life sciences in chemistry, molecular biology, or similar is required.
At least 10 years of experience in Regulatory Affairs CMC in the pharmaceutical and/or biotechnology industry.
Prior success filing clinical trial applications, marketing applications, amendments, supplements, and variations for drugs (biologics, gene therapy, mRNA, small molecules) within timelines is required; global submission experience and/or knowledge of global regulations/requirements, e.g., APAC/LatAm, is a desired plus.
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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