Regulatory Portfolio Manager Senior
1 week ago
Transforming Patients' Lives through Science
Bristol Myers Squibb is a global biopharmaceutical company dedicated to discovering, developing, and delivering innovative medicines that help patients prevail over serious diseases. We are seeking a highly skilled Senior Manager, Regulatory Portfolio Manager to join our team.
Job Summary
The Senior Manager, Regulatory Portfolio Manager will partner with Regulatory Leads and the Global Regulatory Team to deliver and execute the optimal regulatory strategy for assigned assets. This role will report directly to a Group Leader in Regulatory Portfolio Management.
Key Responsibilities
- Develop and maintain the asset's global regulatory book of work and Global Submission Plan, including tracking key regulatory milestones and liaising cross-functionally to generate periodic internal milestone reports.
- Communicate status and timeline changes, and 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, and review prior health authority queries to guide response development.
- Represent the Global Regulatory Lead in team meetings as needed, and partner with the team to co-ordinate preparation of regulatory components for US submissions and author assigned m1 documents.
- Support and co-ordinate preparations for FDA meetings, and provide additional support, such as precedent analysis.
Qualifications & Experience
- Degree or equivalent in a healthcare-related field.
- 2+ 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.
- Strong sense of personal accountability for delivery, and ability to lead through influence and building alignment with stakeholders to deliver projects to plan.
- Continuous improvement mindset, and strategic problem-solving skills.
- Good communication and negotiation skills, and good interpersonal skills.
Bristol Myers Squibb is an Equal Opportunity Employer
We are committed to creating a diverse and inclusive work environment that reflects the communities we serve. We welcome applications from qualified candidates who share our values and are passionate about making a difference in the lives of patients.
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