Director - CMC

About Freyr

Freyr is a global Regulatory Solutions and Services organization supporting Life Sciences companies across Regulatory Affairs, Clinical, Safety, and Compliance. We partner with leading pharmaceutical, biotechnology, and medical device companies, delivering end-to-end regulatory operations support and regulatory strategy with precision, speed, and global expertise.

Job Description (Director level)

Job Title: Director Regional CMC LiaisonObjective / Purpose

The Director CMC Liaison connects global Regulatory CMC teams with local affiliates, driving regional alignment and efficiency in post-approval submissions. This role supports a diverse product portfolio—including small molecules and biologics, ensuring development of regional regulatory strategies in assigned markets, but also development of submission packages and their distribution with a regionalized approach. This role is instrumental in driving efficiency and consistency across countries within the region by leveraging regional strategies and aligning with global submission plans.

Accountabilities

• Act as the primary point of contact between global Regulatory CMC and local affiliates for submission package preparation and delivery.

• Translate global CMC strategies into actionable regional plans, ensuring alignment with country-specific requirements.

• Oversee the preparation, review, and submission of regulatory dossiers across the region.

• Develop and implement regional submission strategies to streamline processes and reduce duplication of effort.

• Partner with affiliates to identify opportunities for harmonization across the region.

• Build strong relationships with local affiliates to understand country-specific regulatory needs and challenges.

• Liaise with global Regulatory CMC teams to provide regional insights and feedback.

• Identify bottlenecks in the regional submission process and propose innovative solutions to enhance efficiency.

• Monitor and report on submission timelines and regulatory approvals across the region.

• Lead or support the development of regional strategies, training, and capability-building initiatives to strengthen the Regional CMC regulatory network.

Education & Competencies

• BS/BA Degree in a Scientific Discipline, Advanced Degree (M.S., Ph.D., etc.) preferred.

• 10+ years of overall biopharmaceutical/device industry experience with 8+ years of relevant pharmaceutical Regulatory CMC or Device experience, including experience leading a major variation/amendment, supporting an initial IND/IMPD preparation, or supporting an initial NDA/BLA. Equivalent industry experience in Pharmaceutical Development, Analytical Development, Production, Quality Assurance can be considered).

• Understanding of scientific principles and regulatory CMC requirements relevant to global drug development and post-market support.

• Strong practical experience with global HA requirements, beyond EU/US.

• Proven ability to understand and communicate regulatory strategy to drug development, registration, and post-market support teams. o Analyze issues with attention to detail. o Ability to assess alternative approaches.

• Proven ability to develop global regulatory strategy recommendations based on precedents and other regulatory intelligence as well as regulations and guidelines.

• Able to deal with issues of critical importance with minimal oversight. Exercises good judgment in elevating and communicating actual or potential issues to line management.

o Understands who is responsible for different decisions and escalates as necessary.

o Applies directions taken by the company.

• Demonstrates emerging leadership, problem-solving ability, flexibility and values teamwork.

o Intentionally promotes an inclusive culture.

o Applies given prioritization framework with limited support.

• Excellent written and oral communication skills required.

• Excellent skills in leadership, collaboration, negotiation, problem solving, and fostering interpersonal connections through teamwork.