Director, RA Global Regulatory Strategy
Posted 2 months ago Expired
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Upload Your ResumeAbout This Role
This Director-level role involves developing and implementing global regulatory strategies for products within a therapeutic area, leading cross-functional teams to secure and maintain market approvals and ensuring compliance with global regulations.
Responsibilities
- Develop and implement global strategies to secure and maintain market approval for product(s) in the assigned therapeutic area
- Lead the Global Regulatory Product Team (GRPT)
- Ensures strategic messaging and content of global regulatory dossiers
- Serve as the primary regulatory interface with AST and supporting teams
- Proactively anticipate and mitigate regulatory risks
- Manage compounds through all phases of development, including post approval and throughout the life cycle of the product
- Develop and implement acceleration strategies
- Make decisions regarding work processes or operational plans and schedules to achieve program objectives
- Lead cross-functional stakeholders and regulatory professionals to ensure appropriate strategic messaging in global regulatory dossiers
- Ensure alignment of global regulatory strategies with Sr. Management
Requirements
- 7+ years regulatory experience (pharmaceutical regulatory work or other R&D role/specialized training)
- Drug development experience in US&C region
- 5+ years in a strategic leadership role with strong project management skills
- Experience working in a complex and matrix environment with multiple stakeholders
- Experience influencing cross-functional teams
- Experience interfacing with major government regulatory bodies
- Strong communication and proactive negotiation skills
- Experience developing and implementing successful global regulatory strategies
Qualifications
- Bachelor's degree in life sciences (pharmacy, biology, chemistry, pharmacology) or related subject
- 7+ years regulatory experience, with 5+ years in a strategic leadership role, including drug development experience in US&C region and managing projects
Nice to Have
- Relevant advanced degree
- Certification
- 10+ years experience in pharmaceutical regulatory activities
- Experience as lead regulatory product strategist in two or more major regions (e.g., EU or Japan)
- Strong global drug development foundation with business acumen
Benefits
About BioSpace
Lilly is a global healthcare leader headquartered in Indianapolis, Indiana, specializing in discovering and bringing life-changing medicines to patients worldwide. They are investing over $1 billion to create a new state-of-the-art manufacturing site in Concord, NC, focusing on parenteral medication...