Senior manager global regulatory affairs

Roles & Responsibilities

• Leads the execution of regulatory CMC investigational, registration and/or post-approval strategies for assigned products.
• RA CMC member on the Global Regulatory CMC team may act as the delegate for the GRA CMC Product Lead at Regulatory, Pharmaceutical Development, and Commercial project teams throughout clinical development and commercial lifecycle.
• Has a strong foundational understanding of global RA CMC regulations and guidelines and can apply this understanding to projects to enhance probability of regulatory success and regulatory compliance.
• Ability to draw from precedents and other regulatory intelligence beyond regulations.
• Strong analytical or process understanding that enables the development of robust and accurate submissions.
• Develops constructive relationships with and proactively communicates issues to key internal and external colleagues, including Alliance Partners.

Minimum Requirements/Qualifications

• BS/BA Degree in a Scientific Discipline, Advanced Degree preferred.
• 6+ years pharmaceutical Regulatory CMC or Device experience, including experience leading a major variation/amendment, supporting an initial IND/IMPD preparation, or supporting an initial NDA/BLA.
• Understanding of scientific principles and regulatory CMC requirements relevant to global drug development and post-market support.
• Proven ability to understand and communicate regulatory strategy to drug development, registration, and post-market support teams.
• Analyze issues with attention to detail. Ability to assess alternative approaches.
• Base regulatory strategy recommendations on precedents and other regulatory intelligence as well as regulations and guidelines.
• Able to deal with issues of critical importance with some supervision.
• Exercises good judgement in elevating and communicating actual or potential issues to line management.
• Understands who is responsible for different decisions and escalates as necessary.
• Applies decisions taken by the company.
• Demonstrates emerging leadership, problem-solving ability, flexibility and values teamwork.
• Intentionally promotes an inclusive culture.
• Applies the given prioritization framework with limited support.
• Excellent written and oral communication skills required.