Assistant Manager, Regulatory Affairs CMC (Global)

We are seeking an Assistant Manager, Regulatory Affairs Global CMC to prepare regulatory assessments and contribute to global regulatory strategies for projects across all aspects of drug development or manufacturing lifecycle. The role involves authoring and coordinating CMC activities, ensuring delivery of high-quality components and submissions, and managing regulatory issues.

Requirements

• Mandatory hands-on CMC authoring experience (initial registrations or post-approval variations)
• 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, commitments and data.
• Updating, interpreting, and applying global and regional CMC guidelines, along with the ability to contribute to global regulatory strategies by proactively discussing with partners.
• Emerging awareness of new scientific or manufacturing technology.
• An understanding and working knowledge of the of global regulatory requirements & expectations and experience interacting with development & manufacturing operations teams.
• Demonstrated commitment & dedication to scientific and regulatory integrity and quality & compliance.
• Advanced skills in written & oral communications (mandatory).
• Computer literacy with Microsoft Office Suite and Documentum-based applications.
• Ability to serve as a Subject Matter Expert in specific relevant disciplines or as a recognized resource for specific pharmaceutical science projects and/or specialized expert in specific regulatory domains.

Benefits

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