Regulatory Portfolio Management Specialist
1 week ago
Job Summary: We are seeking a highly skilled Regulatory Portfolio Management Specialist to join our team at Bristol Myers Squibb. In this role, you will be responsible for providing regulatory support and expertise to ensure compliance with health authority regulations and standards.
Key Responsibilities:
- Liaise with cross-functional teams to generate periodic internal milestone reports and communicate status and timeline changes.
- Monitor key health authority websites for pertinent information and compile regulatory precedents as requested.
- Support the creation and maintenance of a database for global submission country requirements.
- Collaborate with CMC leads to gather auxiliary documentation for clinical and commercial submissions.
- Support submission team meetings and provide regulatory intelligence to inform business decisions.
- Assist with divestitures, product deletions, and asset integrations by working with regulatory leads to document gaps and implement MAT transfers.
- Schedule RRT meetings and communicate timelines to ensure timely responses to health authority queries.
- Review and analyze GRS analytics and compliance reports to inform business decisions.
Requirements:
- A minimum of a Bachelor's degree in a natural science, pharmacy, or other healthcare-related field.
- At least 3 years of experience in the pharmaceutical industry and regulatory affairs.
- Solid understanding of major health authority regulations and standards, with excellent communication and organizational skills.
- Ability to lead cross-functional teams and work independently on multiple projects.
- Proficiency in Microsoft Suite and standard office technology.
Working at Bristol Myers Squibb:
Bristol Myers Squibb is committed to transforming patients' lives through science. Our team is dedicated to delivering innovative solutions that improve healthcare outcomes. As a Regulatory Portfolio Management Specialist, you will be part of a dynamic team that values diversity, inclusion, and collaboration. We offer a competitive compensation package, comprehensive benefits, and opportunities for professional growth and development.
Equal Employment Opportunity:
Bristol Myers Squibb is an equal opportunity employer and welcomes applications from diverse candidates. We are committed to creating a workplace that is inclusive and respectful of all employees. If you require reasonable accommodations or have questions about our equal employment opportunity policies, please contact us at .
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