Senior Manager, Regulatory Affairs CMC

The Senior Manager, Regulatory Affairs CMC will be responsible for ensuring global regulatory compliance, developing and implementing global regulatory strategies, and preparing high-quality CMC submissions. The role will involve leading CMC activities for assigned projects, representing CMC on cross-functional project teams, and collaborating with internal and external stakeholders.

Requirements

• Mandatory hands-on CMC authoring experience
• Sufficient level of knowledge and solid understanding of the development and commercial activities and cGMP's required to assess technical, scientific and regulatory merits of CMC information
• Advanced technical, functional, and industry knowledge to shape strategic direction of assigned project(s)
• Advanced knowledge of regulatory requirements and expectations, criteria for submission and approval globally
• Sound understanding and advanced knowledge of the principles, practices and concepts of regulatory CMC/policy/publishing disciplines
• Computer literacy with Microsoft Office Suite and Documentum-based applications
• Project Management skills
• Ability to engage in the external regulatory and pharmaceutical environment

Benefits

• Competitive salaries
• Benefits
• Inclusive environment
• Excellent career progression opportunities
• Work-life balance initiatives