Senior Manager I, RPM
Bristol-Myers Squibb
Senior Manager I, RPM
Job Description
Partner with the Global Regulatory Lead (GRL) and wider Global Regulatory Sub-Team (GRST) to deliver and execute the optimal regulatory strategy for assigned asset(s): Co-lead GRST meetings in alignment with the GRS Culture Playbook to ensure high quality discussions & decisions; diligent follow-up with sub-team members to uphold accountabilities and drive decision making Develop and maintain the asset's global regulatory book of work and Global Submission Plan including: Tracking key regulatory milestones as defined by the GRST., health authority meetings, post-approval commitments, annual reports, etc. Liaise cross-functionally to generate periodic internal milestone reports Maintaining global submission plans including oversight of the interdependencies across regions for timely execution aligned with the asset's priorities Communicate status and timeline changes Provide operational support to the GRL on strategic global regulatory documents including the Regulatory Strategy Plan Co-ordinate the rapid response process to ensure quality and timely responses to health authority queries globally Review prior health authority queries to guide response development Represent the Global Regulatory Lead in team as needed Partner with the US Regulatory Lead to: Co-ordinate preparation of regulatory components for US submissions and author assigned m1 documents Support and co-ordinate preparations for FDA meetings Provide additional support e.g., precedent analysis Supporting People with Disabilities 3+ years of direct regulatory experience with developing knowledge of US and/or EU procedures Ability to work independently and at pace in a global matrix environment and effectively prioritize multiple projects Strong sense of personal accountability for delivery; able to lead through influence and building alignment with stakeholders to deliver projects to plan Continuous improvement mindset Strategic problem solver Good communication and negotiation skills Good interpersonal skills
Key Responsibilities
- Partner with the Global Regulatory Lead (GRL) and wider Global Regulatory Sub-Team (GRST) to deliver and execute the optimal regulatory strategy for assigned asset(s)
- Co-lead GRST meetings in alignment with the GRS Culture Playbook to ensure high quality discussions & decisions
- Diligent follow-up with sub-team members to uphold accountabilities and drive decision making
- Develop and maintain the asset's global regulatory book of work and Global Submission Plan
- Track key regulatory milestones as defined by the GRST, including health authority meetings, post-approval commitments, annual reports, etc.
- Liaise cross-functionally to generate periodic internal milestone reports
- Maintain global submission plans including oversight of the interdependencies across regions for timely execution aligned with the asset's priorities
- Communicate status and timeline changes
- Provide operational support to the GRL on strategic global regulatory documents including the Regulatory Strategy Plan
- Co-ordinate the rapid response process to ensure quality and timely responses to health authority queries globally
- Review prior health authority queries to guide response development
- Represent the Global Regulatory Lead in team as needed
- Partner with the US Regulatory Lead to co-ordinate preparation of regulatory components for US submissions and author assigned m1 documents
- Support and co-ordinate preparations for FDA meetings
- Provide additional support, e.g., precedent analysis
Required Qualifications
- + years of direct regulatory experience
- Developing knowledge of US and/or EU procedures
Skills Required
- Ability to work independently and at pace in a global matrix environment
- Effectively prioritize multiple projects
- Strong sense of personal accountability for delivery
- Ability to lead through influence and building alignment with stakeholders to deliver projects to plan
- Continuous improvement mindset
- Strategic problem solver
- Good communication and negotiation skills
- Good interpersonal skills
Locations
- Warsaw, United States
Salary
Salary not disclosed
Estimated Salary Rangemedium confidence
150,000 - 220,000 USD / yearly
Source: ai estimated
* This is an estimated range based on market data and may vary based on experience and qualifications.
Skills Required
- Ability to work independently and at pace in a global matrix environmentintermediate
- Effectively prioritize multiple projectsintermediate
- Strong sense of personal accountability for deliveryintermediate
- Ability to lead through influence and building alignment with stakeholders to deliver projects to planintermediate
- Continuous improvement mindsetintermediate
- Strategic problem solverintermediate
- Good communication and negotiation skillsintermediate
- Good interpersonal skillsintermediate
Required Qualifications
- + years of direct regulatory experience (experience)
- Developing knowledge of US and/or EU procedures (experience)
Responsibilities
- Partner with the Global Regulatory Lead (GRL) and wider Global Regulatory Sub-Team (GRST) to deliver and execute the optimal regulatory strategy for assigned asset(s)
- Co-lead GRST meetings in alignment with the GRS Culture Playbook to ensure high quality discussions & decisions
- Diligent follow-up with sub-team members to uphold accountabilities and drive decision making
- Develop and maintain the asset's global regulatory book of work and Global Submission Plan
- Track key regulatory milestones as defined by the GRST, including health authority meetings, post-approval commitments, annual reports, etc.
- Liaise cross-functionally to generate periodic internal milestone reports
- Maintain global submission plans including oversight of the interdependencies across regions for timely execution aligned with the asset's priorities
- Communicate status and timeline changes
- Provide operational support to the GRL on strategic global regulatory documents including the Regulatory Strategy Plan
- Co-ordinate the rapid response process to ensure quality and timely responses to health authority queries globally
- Review prior health authority queries to guide response development
- Represent the Global Regulatory Lead in team as needed
- Partner with the US Regulatory Lead to co-ordinate preparation of regulatory components for US submissions and author assigned m1 documents
- Support and co-ordinate preparations for FDA meetings
- Provide additional support, e.g., precedent analysis
Tags & Categories
Senior Manager I, RPM
Bristol-Myers Squibb
Senior Manager I, RPM
Job Description
Partner with the Global Regulatory Lead (GRL) and wider Global Regulatory Sub-Team (GRST) to deliver and execute the optimal regulatory strategy for assigned asset(s): Co-lead GRST meetings in alignment with the GRS Culture Playbook to ensure high quality discussions & decisions; diligent follow-up with sub-team members to uphold accountabilities and drive decision making Develop and maintain the asset's global regulatory book of work and Global Submission Plan including: Tracking key regulatory milestones as defined by the GRST., health authority meetings, post-approval commitments, annual reports, etc. Liaise cross-functionally to generate periodic internal milestone reports Maintaining global submission plans including oversight of the interdependencies across regions for timely execution aligned with the asset's priorities Communicate status and timeline changes Provide operational support to the GRL on strategic global regulatory documents including the Regulatory Strategy Plan Co-ordinate the rapid response process to ensure quality and timely responses to health authority queries globally Review prior health authority queries to guide response development Represent the Global Regulatory Lead in team as needed Partner with the US Regulatory Lead to: Co-ordinate preparation of regulatory components for US submissions and author assigned m1 documents Support and co-ordinate preparations for FDA meetings Provide additional support e.g., precedent analysis Supporting People with Disabilities 3+ years of direct regulatory experience with developing knowledge of US and/or EU procedures Ability to work independently and at pace in a global matrix environment and effectively prioritize multiple projects Strong sense of personal accountability for delivery; able to lead through influence and building alignment with stakeholders to deliver projects to plan Continuous improvement mindset Strategic problem solver Good communication and negotiation skills Good interpersonal skills
Key Responsibilities
- Partner with the Global Regulatory Lead (GRL) and wider Global Regulatory Sub-Team (GRST) to deliver and execute the optimal regulatory strategy for assigned asset(s)
- Co-lead GRST meetings in alignment with the GRS Culture Playbook to ensure high quality discussions & decisions
- Diligent follow-up with sub-team members to uphold accountabilities and drive decision making
- Develop and maintain the asset's global regulatory book of work and Global Submission Plan
- Track key regulatory milestones as defined by the GRST, including health authority meetings, post-approval commitments, annual reports, etc.
- Liaise cross-functionally to generate periodic internal milestone reports
- Maintain global submission plans including oversight of the interdependencies across regions for timely execution aligned with the asset's priorities
- Communicate status and timeline changes
- Provide operational support to the GRL on strategic global regulatory documents including the Regulatory Strategy Plan
- Co-ordinate the rapid response process to ensure quality and timely responses to health authority queries globally
- Review prior health authority queries to guide response development
- Represent the Global Regulatory Lead in team as needed
- Partner with the US Regulatory Lead to co-ordinate preparation of regulatory components for US submissions and author assigned m1 documents
- Support and co-ordinate preparations for FDA meetings
- Provide additional support, e.g., precedent analysis
Required Qualifications
- + years of direct regulatory experience
- Developing knowledge of US and/or EU procedures
Skills Required
- Ability to work independently and at pace in a global matrix environment
- Effectively prioritize multiple projects
- Strong sense of personal accountability for delivery
- Ability to lead through influence and building alignment with stakeholders to deliver projects to plan
- Continuous improvement mindset
- Strategic problem solver
- Good communication and negotiation skills
- Good interpersonal skills
Locations
- Warsaw, United States
Salary
Salary not disclosed
Estimated Salary Rangemedium confidence
150,000 - 220,000 USD / yearly
Source: ai estimated
* This is an estimated range based on market data and may vary based on experience and qualifications.
Skills Required
- Ability to work independently and at pace in a global matrix environmentintermediate
- Effectively prioritize multiple projectsintermediate
- Strong sense of personal accountability for deliveryintermediate
- Ability to lead through influence and building alignment with stakeholders to deliver projects to planintermediate
- Continuous improvement mindsetintermediate
- Strategic problem solverintermediate
- Good communication and negotiation skillsintermediate
- Good interpersonal skillsintermediate
Required Qualifications
- + years of direct regulatory experience (experience)
- Developing knowledge of US and/or EU procedures (experience)
Responsibilities
- Partner with the Global Regulatory Lead (GRL) and wider Global Regulatory Sub-Team (GRST) to deliver and execute the optimal regulatory strategy for assigned asset(s)
- Co-lead GRST meetings in alignment with the GRS Culture Playbook to ensure high quality discussions & decisions
- Diligent follow-up with sub-team members to uphold accountabilities and drive decision making
- Develop and maintain the asset's global regulatory book of work and Global Submission Plan
- Track key regulatory milestones as defined by the GRST, including health authority meetings, post-approval commitments, annual reports, etc.
- Liaise cross-functionally to generate periodic internal milestone reports
- Maintain global submission plans including oversight of the interdependencies across regions for timely execution aligned with the asset's priorities
- Communicate status and timeline changes
- Provide operational support to the GRL on strategic global regulatory documents including the Regulatory Strategy Plan
- Co-ordinate the rapid response process to ensure quality and timely responses to health authority queries globally
- Review prior health authority queries to guide response development
- Represent the Global Regulatory Lead in team as needed
- Partner with the US Regulatory Lead to co-ordinate preparation of regulatory components for US submissions and author assigned m1 documents
- Support and co-ordinate preparations for FDA meetings
- Provide additional support, e.g., precedent analysis
Tags & Categories