Mexico - Regional Director - Regulatory Affairs CMC

About Freyr

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.

Why Freyr?

At Freyr, we believe in fostering a collaborative and dynamic work environment that empowers our team to make a real impact. As we expand our footprint , we are on the lookout for passionate and skilled Regulatory professionals to join us in shaping the future of regulatory services.

Join Our Team:

If you're ready to embark on a journey of growth and innovation, connect with us to explore the exciting opportunities awaiting you at Freyr. Together, we can shape the future of regulatory solutions.

Title : Director - Regional CMC

Location : Colombia, Remote

Experience : Min 15 years in Regulatory Affairs, CMC

Director – Regional 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):

• BS/BA Degree in a Scientific Discipline, Advanced Degree (M.S), with Ph.D. preferred.
• 15+ years of seasoned biopharmaceutical/device industry experience or with a regulatory agency is preferred, while leading major submissions during LCM, development - including preparation of NDA/NLA/MAA.
• Equivalent industry experience with direct technical/product development experience such as Pharmaceutical Development, Analytical Development, Production, Quality Assurance can be considered.
• People leadership experience (5+ years) required.
• Highly proficient understanding of scientific principles and profound grasp of global regulatory CMC requirements relevant to global drug development and post-market support.
• Keeping abreast of industry insights and regulatory trends to drive organizational evolution.
• Proven ability to understand and communicate regulatory strategy to drug development, registration, and post-market support teams.
• Analyze issues with attention to detail.
• Ability to assess and scientifically justify alternative approaches.
• Base regulatory strategy recommendations on precedents and other regulatory intelligence as well as regulations and guidelines.
• Able to deal with issues of critical importance independently.
• Exercises excellent judgment in elevating and communicating actual or potential issues to line management.
• Understands who is responsible for different decisions, drives and escalates as necessary.
• Implements the directions taken by the company, leading with agility through evolving landscapes.
• Intentionally promotes an inclusive culture, leveraging individual strengths for team success.
• Develops and drives prioritization framework, managing shifting priorities and tight deadlines.
• Exceptional skills in written and oral communication.
• Demonstrates excellent skills in leadership, collaboration, negotiation, problem solving, and fostering interpersonal connections through teamwork.