Director, Regional CMC Regulatory Strategy

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 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.