Manager Regulatory CMC Strategy - Remote

Overview

This position involves shaping global regulatory CMC strategies across the product lifecycle, ensuring regulatory compliance, and collaborating with various teams.

In Short

• Develop and execute regulatory CMC strategies.
• Lead resolution of complex regulatory issues.
• Collaborate with R&D, Quality, and Regulatory Affairs teams.
• Author and review regulatory CMC submissions.
• Ensure accuracy and regulatory compliance of technical documentation.
• Represent CMC on project teams and manage regulatory portfolios.
• Mentor junior team members.
• Contribute to broader regulatory or organizational initiatives.

Requirements

• Experience in regulatory CMC strategy.
• Strong understanding of regulatory compliance.
• Ability to work in a fast-paced environment.
• Excellent communication and collaboration skills.
• Proven project management skills.
• Scientific background preferred.

Benefits

• Opportunity to make a measurable impact.
• Dynamic and collaborative work environment.
• Remote work flexibility.
• Professional development opportunities.