▷ [Buen Sueldo] Regional Director - Regulatory Affairs CMC...

Title

Director – Regional CMC

Location

Bogota, Colombia

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 global and regional stakeholders to identify opportunities for harmonization and efficiency.
• Monitor and report on submission timelines and regulatory approvals, addressing any issues or delays proactively.
• Build and maintain strong relationships with local affiliates to understand and address country-specific regulatory needs and challenges.
• Liaise with global Regulatory CMC teams to provide regional insights and feedback, ensuring a cohesive approach to regulatory submissions.
• Represent the Regional CMC Liaison function in cross‑functional and global meetings, advocating for regional needs and perspectives.
• Identify and address bottlenecks in the regional submission process, proposing and implementing innovative solutions to enhance efficiency.
• Drive continuous improvement initiatives, leveraging best practices and lessons learned to optimize regional submission processes.
• Ensure compliance with regional and country‑specific regulatory requirements and guidelines.

Education & Competencies (Technical and Behavioral)

Salary

COP 3,500,000.00 – COP 4,000,000.00

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