Senior Manager, Oncology, Global Regulatory Strategy

at  BristolMyers Squibb

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 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: careers.bms.com/working-with-us .

POSITION SUMMARY:

Lead and or/support the creation and approval of global regulatory plans in conjunction with Regulatory Leads

Position Responsibilities:

• In close partnership with the regional strategists / liaisons, develop strategic and operational plan for the development and the registration of assets across oncology.
• Lead and/or support marketing application submission teams for indications that are at the regulatory filing stage; helping to develop strategy and content for global dossiers.”
• Develop contingency plans for achieving regulatory objectives with associated risks and mitigation strategies in conjunction with GR T .
• Propose approaches to resolve regulatory issues and appropriately drive speed to patients.
• 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 the 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.
• Understanding of scientific content, drug development and regulatory requirements.
• Participate in the 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, m ain messages from a competitor AdCom.
• 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).
• Facilitate identification of and internal agreement on target labeling

Degree Requirements:

• Minimum of Bachelors required; Scientific background, Ph.D., M.D., PharmD, MS or BS, or equivalent professional experience

Experience Requirements:

• At least 2-4 years of relevant regulatory experience or 4-8 years pharmaceutical industry experience.

If you come across a role that intrigues you but doesn’t 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.

• In close partnership with the regional strategists / liaisons, develop strategic and operational plan for the development and the registration of assets across oncology.
• Lead and/or support marketing application submission teams for indications that are at the regulatory filing stage; helping to develop strategy and content for global dossiers.”
• Develop contingency plans for achieving regulatory objectives with associated risks and mitigation strategies in conjunction with GR T .
• Propose approaches to resolve regulatory issues and appropriately drive speed to patients.
• 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 the 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.
• Understanding of scientific content, drug development and regulatory requirements.
• Participate in the 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, m ain messages from a competitor AdCom.
• 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).
• Facilitate identification of and internal agreement on target labelin