Regulatory Portfolio Management Specialist
4 days ago
At Bristol Myers Squibb, we are transforming patients' lives through science. We are seeking a skilled Regulatory Portfolio Management Specialist to join our team.
As a Regulatory Portfolio Management Specialist, you will play a vital role in ensuring the success of our regulatory strategies and submissions. Your primary responsibility will be to manage and maintain our regulatory portfolio, ensuring compliance with relevant health authority regulations and standards.
This is an exciting opportunity to work with a talented team of professionals who are passionate about making a difference in the lives of patients. If you have a solid understanding of at least one major health authority regulation and regulatory standards, excellent communication and organizational skills, and a meticulous eye for details, we encourage you to apply.
Key Responsibilities:
- Liaise cross-functionally to generate periodic internal milestone reports.
- Communicate status and timeline changes.
- Track key regulatory milestones as defined by the GRT, health authority meetings, post-approval commitments, annual reports, etc.
- Monitor key Health Authority Websites for pertinent information.
- Compile Regulatory precedents as requested.
- Create and support databases for Global Submission Country requirements (CMC, IVDR,...) for new and post-approval submissions.
- Support CMC Leads to gather auxiliary (country-specific) documentation for clinical and commercial Rest of World submissions (non-Module 1).
- Support submission team meetings ROW.
Requirements:
- Minimum of a Bachelor degree in a Natural Science, Pharmacy, or other Healthcare-related field.
- ≥ 3 years in pharmaceutical industry and regulatory experience.
- Solid understanding of at least one major Health Authority (FDA, EMA, MHRA .....) regulations and Regulatory standards.
- Excellent communication and organizational skills and a meticulous eye for details.
- Facilitate negotiation with HAs & key partners on routine matters w/ supervisory consultation.
- Able to make decisions in their sphere of influence.
- Independently work on multiple projects & assignments.
- Able to lead cross-functional teams under supervision.
- Must possess an excellent command of language (English).
- Proficiency in standard office technology, including Microsoft Suite, Outlook Mail/Calendar and willing to learn additional applications as needed.
- Solid knowledge of medical and scientific terminology, and biopharma manufacturing complexities.
Benefits:
- Estimated salary: $120,000 - $180,000 per year.
- Ongoing training and professional development opportunities.
- A dynamic and supportive work environment.
- The opportunity to work on challenging projects that make a real difference in the lives of patients.
We offer a competitive salary range of $120,000 - $180,000 per year, depending on your level of experience and qualifications. In addition to your base salary, you will also receive ongoing training and professional development opportunities, a dynamic and supportive work environment, and the opportunity to work on challenging projects that make a real difference in the lives of patients.
Bristol Myers Squibb is an equal opportunities employer and welcomes applications from diverse candidates. If you have any questions or require reasonable accommodations during the application process, please do not hesitate to contact us.
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