European Regulatory Strategist Senior Manager
1 month ago
Transformative Work Awaits
Bristol Myers Squibb is a global pharmaceutical leader that pushes the boundaries of medical innovation. Our work has the power to transform lives, and we're looking for talented professionals like you to join our team.
The European Regulatory Procedural Strategist (ERPS) role is a critical part of our organization, responsible for leading and managing the procedural and operational aspects of European regulatory filings within the European Centralised Procedure.
Key Responsibilities:
- Develop and implement EU centralised procedural management strategies and lead procedural aspects for new MAA filings and Life Cycle Management (LCM)
- Ensure EU-specific regulatory requirements are met, including procedural and CMC-related requirements for MAAs and LCM
- Plan and track activities related to regulatory submissions in the EU
- Track and inform relevant parties of regulatory submission dates, status, and nature of changes
- Co-lead communication of procedural milestones
- Provide dossier requirements for each submission and review full dossier for submission
- Provide labeling support, including competitive label analyses and SmPC preparation
- Collaborate with the European Regulatory Liaison (ERL) in developing European regulatory and procedural strategy
- Author regulatory documentation, prepare exploratory development documents, and lead reviews of quality variations
- Participate in reviews of new legislations and guidelines, and author/review internal procedures and processes
Required Skills and Qualifications:
- PhD-level scientific background or equivalent experience
- At least 3+ years of direct experience in European centralised procedures or indirect management experience of major Centrally Authorised projects
- Excellent communication, organisation, and attention-to-detail skills, as well as in-depth knowledge of EU Regulatory requirements
- Strong team spirit, ability to collaborate, and excellent interpersonal skills
- Excellent command of spoken and written English
Estimated Salary: $120,000 - $150,000 per year, depending on location and experience. This estimate is based on industry standards and market rates for similar roles in the pharmaceutical sector. At Bristol Myers Squibb, we offer a competitive compensation package, comprehensive benefits, and opportunities for growth and professional development.
Benefits and Opportunities:
- Comprehensive health insurance and wellness programs
- Retirement savings plan with company match
- Flexible work arrangements and telecommuting options
- Professional development and training opportunities
- A collaborative and inclusive work environment
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