Senior Manager, Global Regulatory Strategy & Policy
- Employer
- Bristol Myers Squibb Company
- Location
- Summit East, NJ, United States
- Start date
- Sep 23, 2020
View more
- Discipline
- Marketing, Regulatory, Regulatory Affairs
- Required Education
- Bachelors Degree
- Position Type
- Full time
- Hotbed
- Pharm Country, Best Places to Work
Job Details
POSITION
Senior Manager, Global Regulatory Strategy & Policy
SUPERVISOR
Senior or Executive Director, Global Regulatory Strategy & Policy
DEPARTMENT
Global Regulatory Strategy & Policy
LOCATION
Summit, NJ
DIRECT REPORTS
N/A
PREREQUISITES
Bachelors in scientific discipline; 4-8 years pharmaceutical industry experience; Advanced degree in scientific discipline preferred.
Responsibilities will include, but are not limited to, the following:
- Work with Global Regulatory Strategy Leader and/or US Regulatory Strategy Leaders and product Regulatory and Submission Teams to implement plans for cell therapy products for identified projects in development;
- Lead and/or manage the preparation of submissions, which may include INDs, NDAs, Briefing Documents, Orphan Drug Applications, etc;
- Work with cross-functional groups to define and manage contributions to submissions;
- Participate in or lead the regional Regulatory Sub-team for assigned product(s)/project(s);
- Effectively communicate Regulatory product/project objectives and progress to functional management and Regulatory Sub-team;
- Participate in and/or lead regulatory interactions with FDA, as assigned;
- Participate as Regulatory representative on various cross-functional teams;
- Maintains and reinforces compliance with Company SOPs and Work practices;
- Provide Regulatory research and intelligence support for teams, as assigned;
- Maintain knowledge on the US Regulatory environment, regulations and guidances;
- Become knowledgeable with America's Region (includes Canada and Latin America) and European Regulatory laws/guidances, respective to the program and planned regulatory submissions.
Skills/Knowledge Required:
- Bachelors degree in scientific discipline; Advanced scientific degree preferred;
- Experience in multiple phases of drug development; Experience in Cell Therapy Drug Development a plus;
- 4-8 years pharmaceutical industry experience;
- Good Understanding of the drug development process;
- Strong experience with US Regulatory submissions and dossiers (eg, INDs; NDAs);
- Inter-dependant partnering skills, team-orientated with the ability to influence outcomes are necessary skills in the environment;
- Excellent organizational, communication and time management skills needed to manage multiple ongoing projects simultaneously;
- Must be able to innovate, analyze and solve problems with minimal supervision and attention to detail;
- Domestic and occasional International travel may be necessary.
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.
Company
Bristol Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases.
At Bristol Myers Squibb, we believe in the power of science to address some of the most challenging diseases of our time. Our focus on these unmet needs comes during a remarkable time, when unprecedented scientific breakthroughs are advancing the treatment of disease as never before in human history.
We work every day to transform patients’ lives through science. Each day, our employees around the world work together for patients – they are at the center of everything we do. They inspire us. They are the reason we come to work each day.
We combine the agility of a biotech with the reach and resources of an established pharmaceutical company to create a global leading biopharma company powered by talented individuals who drive scientific innovation.
- Website
- http://www.bms.com/
- Phone
- +1-800-332-2056
- Location
-
430 E. 29th St
14th Floor
New York
New York
10016
United States
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