Associate Director Global Regulator Strategy Neuroscience
Associate Director Global Regulator Strategy Neuroscience
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Job Description
Working with Us
Challenging. Meaningful. Lifechanging. Those arent words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here uniquely interesting work happens every day in every department. From optimizing a production line to the latest breakthroughs in cell therapy this is work that transforms the lives of patients and the careers of those who do it. Youll get the chance to grow and thrive through opportunities uncommon in scale and scope alongside highachieving teams rich in diversity. Take your career farther than you thought possible.
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. Read more: Director Global Regulatory Strategy Neuroscience
Position Summary:
The selected candidate will have leadership responsibility for global regulatory strategy within a development team (DT). Serve as team lead or colead of marketing application submission teams for indications that are at the regulatory filing stage; helping to develop strategy and content for global dossiers.
Position Responsibilities:
Support the preparation of and participate in / lead (as appropriate) key HA interactions. Assure consistent positions on common issues are presented to global HA. Review and approve content of responses to queries from HAs for respective regions/countries
Prepare content for regulatory strategic documentation and Regulatory Project Reviews. Align regulatory plans with commercial and development plans
Develop target labeling and colead the crossfunctional labeling team.
Ensure consistent positions are presented in responses to global health authority (HA) queries.
Ensure global development plans will meet global regulatory requirements by soliciting and integrating regional regulatory strategy liaison input.
In collaboration with the global regulatory team (GRT) develop global submission plans and Health Authority interaction plans.
Provide strategic regulatory input to key development documents including clinical protocols clinical and nonclinical reports and summary documents statistical analysis plans DMC charters IBs DSURs etc.
Colead the crossfunctional rapid response teams to respond to Clinical Trial Application (CTA) queries on new protocols and protocol amendments in compliance with HA deadlines.
Education / Experience Requirements
Bachelors degree required; advanced scientific degree preferred (Masters PhD PharmD BSN etc. with at least 3 years of Regulatory Affairs experience in the pharmaceutical industry.
Key Competency Requirements
Understanding of strategic and tactical role and deliverables of Global Regulatory Strategy in the Product Development and Commercialization process.
Understanding of policy laws regulations and guidelines as they apply to Regulatory Agencies globally for drug development and approval.
Understanding of scientific content and complexities and good knowledge of drug development is desired.
Experience in successfully leading teams; Demonstrated ability to drive quality decisionmaking. Demonstrated ability to organize / prioritize tasks.
Good interpersonal skills: willingness to leverage strengths of the team and cooperate with peers in a crossfunctional environment.
Direct experience in developing strategy and leading teams through interactions with health authorities. Track records of issue resolutions with main regulatory authorities; demonstrated ability to break down complex scientific content into logical components.
Demonstrated ability to negotiate with and influence others. Ability to facilitate issue resolution and conflict management.
Experience with developing and documenting regulatory strategies in coordination with clinical plans and marketing objectives.
Experience with communicating the regulatory strategy issues and risks in written and verbal format to regulatory senior leadership team and other governing bodies.
Ability to broadly represent department functions on project team in a matrix organization. Demonstrated ability to coordinate global activities.
Experience as a member of GRTs project working groups or comparable experience. Experience developing strategy for product partnership (outlicensing divestiture codevelopment inlicensing and acquisitions).
Experience utilizing leadership techniques to drive a team through the stages of team development.
Additional Qualifications:
Strong team player using both internal and external resources to execute regulatory activities and working across organizational functional and geographic boundaries to achieve company goals. Communicates opinions facts and thoughts with clarity transparency and honesty
Demonstrates ownership of results within (and beyond) area of responsibility.
Sets clear and high expectations and holds self and others accountable for decisions and results achieved. Looks for opportunities for continuous improvement.
Travel: Occasional domestic and international travel (less than 10 may be required.
If you come across a role that intrigues you but doesnt perfectly line up with your resume we encourage you to apply anyway. You could be one step away from work that will transform your life and career.
Uniquely Interesting Work Lifechanging Careers
With a single vision as inspiring as Transforming patients lives through science every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in an inclusive culture promoting diversity in clinical trials while our shared values of passion innovation urgency accountability inclusion and integrity bring out the highest potential of each of our colleagues.
Onsite Protocol
BMS has a diverse occupancy structure that determines where an employee is required to conduct their work. This structure includes siteessential sitebydesign fieldbased and remotebydesign jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:
Siteessential roles require 100 of shifts onsite at your assigned facility. Sitebydesign roles may be eligible for a hybrid work model with at least 50 onsite at your assigned facility. For these roles onsite presence is considered an essential job function and is critical to collaboration innovation productivity and a positive Company culture. For fieldbased and remotebydesign roles the ability to physically travel to visit customers patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.
BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application or in any part of the recruitment process direct your inquiries to . Visit to access our complete Equal Employment Opportunity statement.
BMS cares about your wellbeing and the wellbeing of our staff customers patients and communities. As a result the Company strongly recommends that all employees be fully vaccinated for Covid19 and keep up to date with Covid19 boosters.
BMS will consider for employment qualified applicants with arrest and conviction records pursuant to applicable laws in your area.
If you live in or expect to work from Los Angeles County if hired for this position please visit this page for important additional information: data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
Required Experience:
Exec
Employment Type
Full-Time
