Associate Director GRS-CMC Biologics

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.

Summary

The CMC Regulatory Associate Director is responsible for content development, compilation, maintenance,

and review of the Quality Module for regulatory submissions to support biotechnology products regarding:

Clinical trial applications; New marketing applications; HA responses & background packages (including

participating/leading HA meetings); &/or post-approval submissions. In this role, the GRS-CMC Associate

Director will serve as the primary interface between Global Regulatory Sciences and Biometrics (GRSB) &

Global Product Supply (GPS). The GRS-CMC Associate Director will assess Manufacturing Change Controls

for global impact & guide technical teams on practical aspects of global change management.

Responsibilities

Represent regulatory CMC on and/or lead matrix teams for biotechnology pipeline products and/or

commercial products through completion of post-marketing commitments & relevant lifecycle

management projects driven by research, such as pediatric formulations and line extensions.

Independently provide strategic guidance/input related to current regulatory requirements and

expectation for marketing applications, clinical trial applications for projects, and/or lifecycle

changes to marketed products.

Independently manage and prioritize multiple complex projects

Interface with the Health Authorities for CMC submissions and CMC-related issues, with guidance

and oversite from supervisor on complex topics.

Identify, communicate and propose resolutions to routine/complex issues

Interpret global regulations and guidance. Identify regulatory opportunity and risks.

Anticipate and communicate possible regulatory paradigm shifts

Participate in product fact finding meetings

Review and provide regulatory assessments on change controls

Prepare and manage CMC submissions for all global markets while ensuring thoroughness,

completeness and timeliness, including creation and maintenance of strategy documents

Mange relationships with diverse teams

Utilize electronic systems for dossier creation and tracking.

Qualifications

A minimum of a Bachelor's Degree in Life Sciences and 7-10 years of experience in the

pharmaceutical industry (prefer knowledge of biotechnology products, including multi-disciplined

experience) and 6 years of CMC regulatory strategy experience.

Knowledge of CMC regulatory requirements during development and post-approval.

Knowledge of biopharmaceutical development, including biological drug substance and sterile drug

product and analytical methods.

Demonstrated ability to develop/maintain strong working relationships with the regulatory CMC

team and cross functional teams, participate on and/or lead multifunctional teams, handle and

prioritize multiple projects and work independently.

Ability to identify, communicate and resolve complex issues.

Prepare and manage filings and ensure thoroughness, accuracy and timeliness.

Ability to interpret global regulations and guidance.

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.

Company: Bristol-Myers Squibb

Req Number: R1522878_EN

Updated: 2020-03-13 00:00:00.000 UTC

Location: New Brunswick,New Jersey

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, age, disability, protected veteran status, pregnancy, citizenship, marital status, gender expression, genetic information, political affiliation, or any other characteristic protected by law.

Company info

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