Freyr is a fast-growing, innovative company specializing in providing end-to-end regulatory solutions and services for the Life Sciences industry. With a commitment to excellence and innovation, we assist pharmaceutical, medical device, and biotech companies in navigating the complexities of regulatory compliance.
Title
Director – Regional CMC
Location
Colombia, Remote
Experience
Min 15 years in Regulatory Affairs, CMC
Objective
The Director – Regional CMC will manage the Regional CMC team, ensuring seamless integration between global Regulatory CMC strategies and local affiliate execution. This role is pivotal in driving regional alignment, efficiency, and consistency in post-approval submissions across a diverse product portfolio, including small molecules, biologics, vaccines, and plasma-derived therapies. The Director – Regional CMC will champion the development and implementation of regional strategies, fostering collaboration and process improvement to meet regulatory requirements effectively and efficiently.
Primary Responsibilities
- Oversee and manage the Regional CMC team, providing guidance, training, and support to ensure high performance and professional development.
- Foster a collaborative and inclusive team environment, promoting knowledge sharing and best practices.
- Develop and execute a strategic vision for the Regional CMC Liaison function, aligning with global Regulatory CMC objectives.
- Ensure the team is equipped with the necessary skills, knowledge, and resources to excel in their roles.
- Translate global CMC strategies into comprehensive regional plans, ensuring alignment with country-specific regulatory requirements.
- Oversee the development and implementation of regional submission strategies to streamline processes and reduce duplication of effort.
- Partner with integral and regional stakeholders to identify opportunities for harmonization and efficiency.
- Monitor and report on submission timelines and regulatory approvals, a