- Lead asset strategy and compliance best practices across products within a modality.
- Review major regulatory submissions and help set up regulatory strategic plans.
- Develop and cross-train staff for maximum flexibility and growth.
- Execute specification strategy for regulatory submissions and address agency concerns.
- Collaborate with cross-functional teams to support product specifications and shelf-life strategy.
- Serve as the Specification Review Board Chair and ensure cross-functional vetting of specifications.
- Represent Biogen at external forums to stay abreast of emerging expectations and trends.
- Ensure timely completion of Annual Product Review/Product Quality Review and trend monitoring.
- Support internal audits, certifications, and external audits of CMOs.
- Support combination product and device implementations in asset strategy.
Requirements
- Bachelor’s degree and at least 12 years of experience in the pharmaceutical industry, with biological product development and/or production.
- At least 7 years of experience in Quality associated with biopharmaceutical/pharmaceutical production.
- Minimum of 5 years of experience in people management and project management.
- Extensive knowledge in GMPs, GCP, GDP, ICH, and international regulations.
- Experience in an international matrix environment.
- Technical expertise in manufacturing, testing, or technical development.
- Strong written and verbal communication skills.
- Ability to influence partners and stakeholders with strong negotiation skills.
Core Competencies
Demonstrates extensive expertise in regulatory strategy and compliance within the pharmaceutical industry, with a strong focus on GMPs, GCP, and international regulations. Proven ability to lead cross-functional teams, manage projects, and influence stakeholders effectively.
Highest-signal resume keywords
- Regulatory Strategy Development
- GMP Knowledge
- Quality Management Experience
- People Management
- Project Management
ATS Optimization Keywords
Hard Skills
- Regulatory Submissions
- Specification Strategy
- Biological Product Development
- Technical Development
- Trend Monitoring
Soft Skills
- Strong Communication Skills
- Negotiation Skills
- Influencing Skills
Industry Keywords
- Pharmaceutical Industry
- Biopharmaceutical Production
- International Regulations
- GCP
- GDP
- ICH
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