Senior Director, Regulatory Affairs

Overview

Celularity is a next-generation Biotechnology company creating off-the-shelf allogeneic cellular medicines for Cancer, Infectious Diseases, and Degenerative Diseases. Our employees are experienced cellular medicine leaders and innovators and are revolutionizing the way the industry approaches disease.  

The Senior Director, Regulatory Affairs will be responsible for developing, optimizing, and implementing regulatory strategy and regulatory plan for assigned development programs.  The candidate will liaise with the US FDA and other global health authorities to facilitate product development, and ensure high-quality regulatory submissions, and timely clearance or approval of INDs, CTAs and marketing applications. 

Responsibilities

• In adherence to corporate objectives, with guidance from regulatory affairs management, develop and implement regulatory and risk mitigation strategy and plan, and ensure regulatory compliance for assigned development programs.
• Collaborate with clinical, nonclinical, product development/CMC, quality assurance, project management, and other relevant functional areas to drive product development towards successful registration and approval.
• Lead cross functional teams to prepare and review regulatory documents to ensure high quality and timely submission to health authorities, including but not limited to IND and amendment, BLA, safety reporting, periodic reporting, and response to health authority questions.
• Manage labeling development, and advertising/promotional review activities.
• Lead the preparation and conduct of meetings with health authorities for assigned programs, including but not limited to INTERACT and pre-IND meetings, Type C meetings, EOP2 meetings and pre-BLA meetings with the US FDA and Scientific Advice meetings with global health authorities.
• Monitor the changes in regulatory environment, regulation, regulatory guidance, and regulatory guidelines. Advise companies on the potential impact of these changes on company drug development programs and adjust regulatory and risk mitigation strategies accordingly.
• Support business needs to take on additional project responsibilities as assigned by management.
• Guide regulatory consultants and contractors to complete and/or manage all assigned responsibilities in a timely manner.

Qualifications

• BA/BS or MS degree in a scientific discipline. Advanced degree (MD, PhD, DVM or PharmD) in pharmaceutical sciences is preferred.
• Minimum of 12 years of experience in biotechnology or pharmaceutical industry; of which 8 years in Regulatory Affairs including 4 years in oncology, gene therapy or cell therapy product development preferred. Candidates who have had NDA or BLA submission and approval experience in areas other than oncology, gene therapy or cell therapy will be considered.
• Ability to develop, optimize and implement regulatory strategy and plan, taking into consideration changes in treatment paradigm, competitive landscape, regulatory environment, available data, functional and regional considerations, among other things.
• Track record of successful IND/CTA submissions and approvals/clearance, and supplemental marketing application submissions and approvals. Prior experience of leading an original NDA or BLA is desirable.
• Direct experience of interacting with the US FDA and other global health authorities.
• Demonstrated knowledge of drug, biologics and medical device regulation, directives, and regulatory guidance and guidelines. Solid knowledge of GCP, cGMP and GLP.
• Experience in leading matrix teams to fulfill regulatory requirements and responsibilities. A team player with a good track record of collaboration cross functionally and with strong interpersonal skills.
• Strong organizational skills and able to prioritize and manage multiple ongoing projects simultaneously.
• Excellent oral and written communication skills.
• Strategic yet attention to details.
• Adaptive to changes with demonstrated learning agility.