Associate Director Regulatory CMC

Profile

Bristol-Myers Squibb is a global Biopharma company committed to a single mission: to discover, develop, and deliver innovative medicines focused on helping millions of patients around the world in disease areas such as oncology, cardiovascular, immunoscience and fibrosis.

Join us and make a difference. We hire the best people and provide them with a work environment that places a premium on diversity, integrity, collaboration and personal development. Through a culture of inclusion, we create a better, more productive work environment. We believe that the diverse experiences and perspectives of all our employees help to drive innovation and transformative business results.

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

Bristol-Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees the resources to pursue their goals, both at work and in their personal lives.

Bristol-Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

Company info

Bristol-Myers Squibb Company
Website : http://www.bms.com