Senior Director, Regulatory Affairs

Company: Bristol-Myers Squibb
Location: Jersey City
Posted on: February 13, 2021

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. POSITION Senior Director, Regulatory Affairs SUPERVISOR Vice President, Regulatory Affairs DEPARTMENT Regulatory Affairs Location NJ Grade D09 Direct Reports N/A PREREQUISITES Advanced scientific discipline degree: 8-12 years pharmaceutical industry experience, with 6-8 years in regulatory area. MD, PhD or PharmD preferred. About Bristol-Myers Squibb 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 will include, but are not limited to the following: Develop US Regulatory strategies and operational plans for identified investigational and marketed products. Working with regional staff, assemble the global regulatory plans for identified projects/products. Is extremely knowledgeable with US laws and guidelines and is familiar with the EU and Japan regulatory environment. Provides strategic and operational advice to the development and commercialization teams, serving as the primary global point person for assigned projects. Evaluates emerging regulations and changing regulatory landscape for impact and provides strategic advice for assigned projects. Provides leadership to the larger regulatory team that supports assigned projects and manages assigned regulatory staff. Is the lead Regulatory person; providing primary interface for FDA on assigned projects. Works with the regulatory product managers (submissions) and regulatory operations group, for preparation, production and submission of health authority documents using internal & external resources. Works with regional staff outside US for ROW health authority submissions. Identifies issues or is assigned projects that will impact Celgene, regulatory affairs or projects and provides strategies for dealing with them. Acts as key regulatory representative on various cross-functional teams as assigned. Skills/Knowledge Required:

• Advanced degree in scientific discipline; MD, PhD or PharmD preferred, experience in oncology or inflammatory disease drug development preferred.
• 8-12 years pharmaceutical industry experience, including 6-8 years in regulatory affairs. Global experience very desirable. US experience necessary. EU/other regional experience good to have.
• Thorough knowledge of the drug research, development, and commercialization process.
• Demonstrated specific expert in one or more key areas - Drug Development/CMC/Pharmtox/ Biopharmaceutics/Clinical/Promotional.
• Inter-dependant partnering skills, team-oriented and ability to influence outcomes necessary. Sensitivity and experience with non-domestic organizations/cross-cultural environments.
• Excellent organizational, communication and time management skills needed to manage multiple ongoing projects simultaneously.
• Must be able to innovate, analyze and solve critical/complex business problems with minimal supervision and with good attention to detail. Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues. 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 with the resources to pursue their goals, both at work and in their personal lives. W e're creatinginnovative medicines for patients fighting serious diseases. We're also nurturing our own diverse team with inspiring work and challenging career options. No matter the role, each one of us makes a contribution. And that makes all the difference.

Keywords: Bristol-Myers Squibb, Jersey City , Senior Director, Regulatory Affairs, Executive , Jersey City, New Jersey