Bristol Myers Squibb
Healthcare
SeniorManager,GlobalRegulatoryStrategy,Neurosciences
Neural analysis suggests this role is
optimal for Manager candidates.
“Senior Manager, Global Regulatory Strategy, Neurosciences at Bristol Myers Squibb. Skills: Global Regulatory Strategy, Neurosciences, Drug development, Regulatory filing. Develop strategic and operational plan for development and. Lead development of strategy and content for US”
What You'll Achieve.
Achieve regulatory objectives; Drive speed to patients
Industry & Context.
Solution-oriented; Resolve regulatory issues; Identify regulatory risks; Propose mitigations
Occasional travel, domestic
What They're Looking For.
Must Have
min 2 to 8 years regulatory experience, Scientific background, Ph.D., M.D., PharmD, MS or BS, or equivalent professional experience, adequate knowledge of drug development, adequate knowledge of policy, laws, regulations and guidelines as they apply to the FDA for drug development and approval
Nice to Have
Experience in Neuroscience
What You'll Do.
Develop strategic and operational plan for development and
Lead development of strategy and content for US
Develop contingency plans for achieving regulatory objectives
Develop approaches to resolve regulatory issues
Drive speed to patients
Develop predictions for expectations and risks associated with
Identify regulatory risks
Propose mitigations to senior leaders
Lead global health authority interactions
Prepare objectives for meetings
Outline briefing material
Facilitate content discussions
Contribute to building trusted relationship with Health Authorities
Lead preparation of responses to queries from HAs
Contribute to content of responses to queries from
Provide input to key development documents
Lead assessment of regulatory precedence
Lead assessment of regulatory scientific guidelines
Lead identification and compilation of regulatory lessons learned
Bring regulatory and clinical experts together
Track schedules of relevant Public-Private regulatory meetings
Track attendance of relevant Public-Private regulatory meetings
Track schedules of FDA workshops
Track attendance of FDA workshops
Contribute to one regulatory voice to key stakeholders
Contribute to one regulatory voice to key stakeholders
How You'll Work.
Team & Collaboration
Cross-functional environment; With outside partners; With senior leaders; With cross-functional teams; With operational partners; With health authorities
Communication Scope
Build trusted relationship
Full Job Description
**Working with Us** Challenging. Meaningful. Life-changing. Those aren’t 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. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. 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: [careers.bms.com/working-with-us](https://careers.bms.com/working-with-us). **Position Responsibilities** * In close partnership with the regional strategists / liaisons and/or GRL Team leader, develop strategic and operational plan for the development and the registration of assets across Therapy Area. * Lead development of strategy and content for US dossier in partnership with marketing application submission teams for indications that are at the regulatory filing stage; * Develop contingency plans in conjunction with the GRL or Team Leader for achieving regulatory objectives with associated risks and mitigation strategies in conjunction with GRT * Develop and execute approaches to resolve regulatory issues and appropriately drive speed to patients. * Develop predictions for expectations and risks associated with outcomes by regulatory agencies, identifies regulatory risks and proposes mitigations to senior leaders and cross-functional teams. * Lead and/or support global health authority interactions by preparing objectives for meetings, outline of briefing material, facilitating content discuss
Applying for this Senior Manager, Global Regulatory Strategy, Neurosciences role?
Most applicants get filtered before a human reads their resume. See if yours makes the cut.
How to Apply on Workday
- Workday has a multi-step form — save your progress after every section.
- "Apply With LinkedIn" can fail or lose data; manual entry is more reliable.
- Watch for the "Submit for Review" final step — hitting "Save" alone does not submit.
- Job requisition numbers are useful when following up with HR by email.
ANONYMOUS · UNFILTERED
What do employees actually say about Bristol Myers Squibb?
Real rants from real employees. Read before you apply.