About Eirgen Pharma
Founded in 2005, Eirgen is on an exciting path of expansion and innovation. With world-class quality standards as our foundation, we are scaling up to meet our 2025 growth ambitions. Our strengths lie in our capability to rapidly introduce new products and add additional volume to existing products - ensuring supply for new product launches and expanding market opportunities.
What makes us different is that while we continue to grow our business we have still maintained that small company feel to our culture which enables us to ensure that our employees are always front and centre in everything we do. By creating a progressive and dynamic working environment, where hard work and enjoyment aren’t mutually exclusive, we have created a high performing, people-centric culture which allows us to work in an environment where the focus is always on ensuring that the patient comes first.
About the Job
The Regulatory Affairs Specialist is responsible for supporting regulatory activities required for the registration, maintenance, and lifecycle management of Eirgen/OPKO human and veterinary products across global markets, including the EU, US, and Asia-Pacific regions.
The role involves assisting in the preparation and submission of high-quality regulatory documentation, ensuring compliance with global regulatory requirements, and collaborating closely with cross-functional project teams.
The Specialist will contribute to project coordination, regulatory intelligence activities, and timely execution of regulatory milestones to support successful product development and market access.
Key duties include but are not limited to:
Project Planning & Coordination
- Support the planning of regulatory requirements to meet key project milestones and timelines.
- Assist in identifying tasks, timelines, and resources required for regulatory workstreams.
- Contribute to regulatory activities associated with clinical trials, including submissions and support for Investigational Medicinal Product (IMP) management.
Regulatory Compliance
- Support licence maintenance activities and assist internal teams in responding to regulatory compliance queries.
- Work closely with Quality Assurance (QA) and other functional teams to ensure continued compliance with applicable regulations and standards.
Licensing Activities
- Assist with the lifecycle management of existing Marketing Authorisations across markets including Europe, the US, Japan, Canada, South America, and Asia-Pacific regions.
- Prepare variations, renewals, amendments, and other licence maintenance documentation.
Dossier Preparation
- Contribute to the preparation, review, and submission of regulatory dossiers, including CTD modules and country-specific documentation.
- Collaborate with R&D, Quality, Production, and external experts to gather required data and ensure completeness.
Strategic Regulatory Support
- Support the execution of regulatory strategies to facilitate timely product registration and ongoing compliance in target markets.
- Assist in identifying regulatory risks and opportunities during product development and lifecycle management.
Team Collaboration & Knowledge Sharing
- Work collaboratively with members of the Regulatory Affairs team and project teams to support knowledge transfer and ensure consistent regulatory processes.
- Participate in problem-solving discussions to identify and address regulatory challenges early.
Regulatory Intelligence & Policy Monitoring
- Monitor regulatory changes, guideline updates, and global trends relevant to Eirgen’s product portfolio.
- Summarize the potential impact of regulatory developments and communicate key insights to internal stakeholders.
About You
B.Sc. in a Science-related discipline (e.g., Chemistry, Pharmacy, Pharmacology, or related field).
Minimum 2–3 years of experience in Regulatory Affairs within the pharmaceutical or related industry.
Experience supporting regulatory submissions for major global markets (EU, US, Asia-Pacific preferred). Understanding of key international guidelines (ICH, EMA, FDA, JP). Experience interacting with cross-functional teams (e.g., QA, QC, R&D, Production). Prior involvement in dossier assembly, licence maintenance, or regulatory documentation preparation.
Working at Eirgen – What to expect
At Eirgen, we have developed a diverse, people-centric, high performance culture where people are enabled to achieve their potential. If you are working at Eirgen, then we think you’ve got something special. Our employees are high-performing and work as part of a cohesive team, they are dedicated people who are driven to succeed and are rewarded with competitive salaries and an attractive range of benefits including opportunities for career progression and continuing education.
Closing date for applications is Monday, 15-December-2025.
Direct applicants only. We are not accepting assistance from recruitment agencies at this time.