Sr./Executive Director, Regulatory Affairs

Sr./Executive Director, Regulatory Affairs

Pittsburgh, PA

Job Title: Sr./Executive Director, Regulatory Affairs
FLSA Status: Full-Time/Exempt
Department: Clinical Development
Date: April 8, 2022
Manager: Chief Medical Officer
Location: Pittsburgh, PA
Job Code: BIO-22-031

BlueSphere Bio was founded to deploy its novel TCXpress™ technology to unlock the potential of personalized T cell therapy for the treatment of cancer by harnessing the unique specificity of each patient’s T cells for the molecular fingerprint of each patient’s cancer.

Our trailblazing, proprietary TCXpress platform is an elegant, rapid approach that exploits the patient’s immune defenses to attack their cancer specifically and is designed to leave normal tissues untouched, thereby reducing harmful side effects.

The TCXpress™ platform and its implementation will allow us to deliver rapid, personalized T cell treatments for various cancer indications.

We are seeking a creative, visionary Senior/ Executive Director of Global Regulatory Affairs to help build the company’s pipeline and transform patient lives. This role will be part of the company’s development team and contribute to the company’s vision, reporting to the CMO. The Sr/ Exec Dir of Global Regulatory Affairs will be a key position accountable for the creation and execution of worldwide regulatory strategy, including authoring regulatory documents. The candidate is responsible for managing all interactions with and submissions to regulatory authorities. The candidate must be able to lead and interact with multi-disciplinary teams efficiently. The successful candidate will have a track record of accomplishments in global regulatory affairs, specifically cell and gene therapy products and adoptive T cell therapies. S(he) must exhibit excellent leadership, project management, and strong collaboration and communication skills.

Duties and Responsibilities
• Write and edit briefing books, regulatory agency responses, and other documents for national and international studies/submissions, including product labeling.
• Provide project teams with strategic regulatory guidance to expedite product development, registration, and life cycle management.
• Provide regulatory oversight and strategic and technical guidance in discussions with teams in support of due diligence for potential in-licensing activities, external collaborations, and acquisitions.
• Lead interactions with FDA and other Health Authorities, including as they pertain to CMC
• Maintain knowledge of highly complex regulatory requirements up to the current date while influencing the preparation of new regulatory guidance wherever possible.
• Author SOPs, process documents, global policies, author guidance, and other documents to support the organization.
• Ensure documents are accurate, complete, adhere to applicable regulatory guidelines and departmental and editorial standards, and are appropriately formatted for publishing and submission.
• Other duties as assigned

Qualifications and Work Experience
• MD or Ph.D. in related science, preferably immunology
• Minimum 10-15 years of Regulatory experience with increasing responsibilities in a pharmaceutical or biotechnology environment. The position also requires a minimum of 3-5 years of leadership experience in a global regulatory affairs role. Experience in cell therapy is preferred.
• Demonstrated expertise in CMC regulatory matters.
• Excellent working knowledge of the US, European and Asian regulations regarding biologics and cell and gene therapy
• Must have extensive knowledge of regulatory requirements and guidances, including ICH and regional requirements and understand current global and regional trends in regulatory affairs and the ability to assess the impact of these requirements to the business.
• Experience in the preparation and submission of BLA/NDA/MAAs for submission within expedited timelines across the regions.
• Demonstrated global leadership capability, ideally gained through regulatory leadership of multiple global development programs and NDA/MAA submissions.
• Negotiation, influence, and excellent interpersonal communication skills are required.
• Extensive experience with regulatory operations and submission publishing.
• Must be able to travel (US/international) up to 20%.

BlueSphere Bio is an Equal Opportunity Employer (EOE) and offers employment opportunities to all qualified persons regardless of race, color, religion, sex, age, national origin or ancestry, physical or mental disability (except where physical or mental abilities are a bona fide occupational requirement), veteran status, marital status, familial status, sexual orientation, HIV-positive status, possession of the sickle cell trait, genetic characteristics, political views, and any other basis protected by federal, state or local laws.

Please send a cover letter to apply for this position (including job code) and CV/Resume. Internal candidates interested in this opportunity should submit their CV/Resume within 2-weeks of the posting date above and explain why you are interested in this position.

BlueSphere Bio