Senior Manager, Global Regulatory Strategy, Neurosciences

Bristol Myers Squibb • Montreal, QC

2d • CA$130,820 - CA$158,517 • Onsite

About The Position

Working at Bristol Myers Squibb offers uniquely interesting work that transforms the lives of patients and the careers of those who do it. Employees have the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Bristol Myers Squibb recognizes the importance of balance and flexibility in its work environment, offering a wide variety of competitive benefits, services, and programs that provide employees with the resources to pursue their goals both at work and in their personal lives.

Requirements

• Scientific background, Ph.D., M.D., PharmD, MS or BS, or equivalent professional experience.
• min 2 to 8 years years of relevant regulatory experience are required depending on the type of experience and scientific background.
• An adequate knowledge of (i) drug development and (ii) policy, laws, regulations and guidelines as they apply to the FDA for drug development and approval is required.
• Good interpersonal skills: willingness to leverage strengths of the team and cooperate with peers within a cross-functional environment.
• Proven ability to work with outside partners.
• Ability to understand scientific content.
• Demonstrated ability to be solution-oriented.
• Seeks multiple perspectives and listens openly to others’ points of views.
• Enables and demonstrates the courage to speak up on issues and risks as well as on the good news.
• 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.

Nice To Haves

• Experience in Neuroscience would be a plus

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 discussions and input.
• Contribute to building a strong and trusted relationship with Health Authorities.
• Lead preparation of, and contribute to, the content of responses to queries from HAs for respective regions/countries.
• Provide input to key development documents, including clinical protocols, clinical and nonclinical reports and summary documents, statistical analysis plans, DMC charters, IBs, DSURs; (US Regulatory documents such as BTD, ODD, iPSP) etc.
• Lead assessment of regulatory precedence and regulatory scientific guidelines.
• Lead identification and compilation of regulatory lessons learned, bringing the appropriate regulatory and clinical experts together, e.g., registrational program precedents, integrated summaries of EPARs and SBOA, main messages from a competitor AdCom.
• Use and share learnings and best practices.
• Track schedules and attendance of relevant Public-Private regulatory meetings or FDA workshops.
• Contribute to one regulatory voice to key stakeholders internally and externally (operational partners, health authorities).

Benefits

• Competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: Ph.D. or professional degree