Director - CMC

Freyr Solutions; Dublin; On-site; EUR 180,000 - 240,000; Full time

Job summary

Freyr Solutions, a global Regulatory Solutions organization, seeks a Director-level CMC Liaison in Ireland to connect global CMC teams with local affiliates, shaping regional regulatory strategies and submission packages for biopharmaceuticals and devices.

You will translate global CMC strategies into regional plans, oversee regional dossiers, and drive efficiency by harmonizing regional processes across multiple countries. Strong leadership, communication, and regulatory expertise are essential.

Qualifications

• BS/BA in a Scientific Discipline; advanced degree preferred.
• 10+ years in biopharma/device with 8+ years Regulatory CMC or Device experience.
• Experience leading a major variation/amendment or supporting an IND/IMPD/NDA/BLA.
• Understanding of global CMC requirements beyond EU/US.
• Excellent written and oral communication; leadership and collaboration.
• Ability to analyze issues with detail and escalate as needed.
• Ability to communicate regulatory strategy to drug development and post-market teams.

Responsibilities

• Act as primary contact between global Regulatory CMC and local affiliates for submissions.
• Translate global CMC strategies into regional plans.
• Oversee preparation, review, and submission of regulatory dossiers regionally.
• Develop regional submission strategies to streamline processes and reduce duplication.
• Partner with affiliates to identify opportunities for harmonization across the region.
• Build strong relationships with local affiliates to understand country-specific regulatory needs.
• Liaise with global Regulatory CMC teams to provide regional insights.
• Identify bottlenecks in the regional submission process and propose solutions.
• Monitor submission timelines and regulatory approvals across the region.
• Lead or support the development of regional strategies, training, and capability-building initiatives.

Skills

Leadership

Communication

Teamwork

Problem solving

Negotiation

Regulatory knowledge

Education

Bachelor's in science

Advanced degree preferred

Job description

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)

Objective / 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.
• 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.
  • Analyze issues with attention to detail.
  • Ability to assess alternative approaches.
• 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.
  • Understands who is responsible for different decisions and escalates as necessary.
  • Applies directions taken by the company.
• Demonstrates emerging leadership, problem-solving ability, flexibility and values teamwork.
  • Intentionally promotes an inclusive culture.
  • 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.