Associate Director, Global Regulatory Sciences
Posted on Apr 5, 2021 by Bristol-Myers Squibb
At Bristol Myers Squibb, we are inspired by a single vision - transforming patients' lives through science. In oncology, hematology, immunology and cardiovascular disease - and one of the most diverse and promising pipelines in the industry - each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.
Responsible for the development of the CMC regulatory strategy for submissions. These submissions include IND/CTA, NDA, CTD and MAA regulatory filings.
Collaborate with other relevant line functions to prepare and review CMC submission documents, registration dossiers, and responses to health authorities.
Responsible for the regulatory evaluation of CMC change controls.
Responsible for the management of CMC activities related to specific developmental or commercial compounds.
Represent Regulatory CMC on CMC development/commercial and Regulatory Affairs teams.
In addition take on leadership role in the CMC development/commercial teams. Interact with regulatory agencies and represent CMC at regulatory agency meetings.
BS/BA degree in Scientific Discipline (Masters or higher preferred) with 7-9 years in the pharmaceutical industry or in CRO, including 4-6 years' CMC regulatory experience.
Must have experience with CMC regulatory documents (NDA, MAA, CTD, annual reports, supplements, responses and IND/CTAs)
Knowledge of FDA, EMEA and ICH guidelines
Have a solution-oriented approach to problem solving
Experience in developing CMC regulatory strategy
Expertise in either the drug development process or post approval activities
Ability to work on complex projects and within cross-functional teams
Excellent grammar and communication skills, both written and oral
Prior supervisor or project management experience