Associate Director, Global Regulatory Sciences

Job Description
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.

Responsibilities

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.

Qualification/Skills/Knowledge Required

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