The regulatory function is vital in making safe and effective healthcare products available worldwide. Individuals who ensure regulatory compliance and prepare submissions, as well as those whose main job function is clinical affairs or quality assurance are all considered regulatory professionals.
One of our most valuable contributions to the profession is the Regulatory Code of Ethics. The Code of Ethics provides regulatory professionals with core values that hold them to the highest standards of professional conduct.
Like all professions, regulatory is based on a shared set of competencies. The Regulatory Competency Framework describes the essential elements of what is required of regulatory professionals at four major career and professional levels.
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Biologics, Biotechnology, Quality/Risk Management, US Regulatory Affairs
4 Year Degree
The Senior Director Regulatory Affairs CMC will report to the Vice President Regulatory Affairs and will lead the Regulatory Affairs CMC group within the Regulatory Affairs function. This includes strategic and operational oversight of all US and ROW Regulatory Affairs CMC activities, as well as management of the personnel and contractors in the Regulatory Affairs CMC group. The candidate will serve as an internal subject matter expert with respect to the interpretation of relevant drug development regulations and guidance and provide strategic input for the Company’s global regulatory strategies for the life cycle management of OxbrytaTM and the development of pipeline products. This person will contribute to all FDA and other health authority interactions for the Company’s marketed and pipeline products while ensuring the highest integrity in regulatory and quality compliance.
Lead the Regulatory Affairs CMC group to prepare and submit high-quality regulatory CMC submissions in collaboration with Technical Operations, Quality, and Regulatory Affairs colleagues to meet company and project goals; ensure CMC?related documents are complete, well?written, and meet all relevant regulatory requirements
Either directly or through delegation to staff, provide regulatory affairs CMC strategic guidance to product teams for life cycle management of OxbrytaTM and development of pipeline products, including timely development and execution of robust global regulatory strategies, regulatory risk assessments, and mitigation plans
Initiate and lead discussions with health authorities to proactively resolve CMC issues
Manage, mentor, and grow a group of experienced regulatory CMC professionals in a very collaborative environment; support staff in developing regulatory strategies and meeting all regulatory CMC deliverables within defined timelines
Lead regulatory CMC intelligence activities and provide counsel, training, and interpretation of FDA and other health authority feedback, policies and guidelines to GBT personnel
Collaborate with Technical Operations, Quality, and Regulatory Affairs colleagues to ensure compliance with CMC regulatory requirements in regulatory regions of interest and anticipate CMC regulatory requirements for future submissions
Manage, track, and assure accountability to global regulatory CMC commitments
Support Quality and CMC team during GMP inspections
Assess regulatory impact of proposed manufacturing process changes
Internal Number: 757
GBT is a biopharmaceutical company determined to discover, develop and deliver innovative treatments that provide hope to underserved patient communities. The company has one FDA-approved therapy for sickle cell disease and one investigational therapy in development for the disease.