Founded in ****, 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 **** 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
To provide strategic leadership and hands-on management for all regulatory affairs activities supporting the registration, maintenance, and compliance of Eirgen/OPKO products (both Human and Veterinary) across key global markets including the US, EU, and Japan.
This role ensures timely and successful submissions, approvals, and renewals by collaborating closely with cross-functional teams such as Quality Assurance, Clinical, Manufacturing, and Marketing.
To lead, develop, and mentor the Regulatory Affairs team, fostering a high-performance culture focused on continuous improvement, regulatory intelligence, and proactive problem-solving.
To establish, monitor, and report on department goals, project plans, and milestones, ensuring alignment with strategies and regulatory requirements.
To oversee and manage the department's budget and resource allocation, ensuring financial discipline and cost-effectiveness in line with the approved budgets.
To act as a key liaison with regulatory agencies and external partners, building strong relationships to facilitate product registrations and regulatory compliance.
To continuously monitor global regulatory landscapes and emerging trends, interpreting impacts on current and future product portfolios, and advising senior management on regulatory risks and opportunities to support business growth and product lifecycle management.
Key duties include but are not limited to:
Project Planning and Coordination
Actively plan and define regulatory requirements, ensuring all major project milestones and deadlines are clearly communicated and understood by team members and key stakeholders to guarantee timely market entry.
Identify and allocate tasks and resources needed to meet project goals, while continuously monitoring progress and addressing any obstacles or delays.
Take direct ownership of regulatory activities related to clinical trials, including obtaining and maintaining necessary approvals and managing Investigational Medicinal Product (IMP) logistics efficiently.
Regulatory Compliance
Oversee all aspects of licence maintenance to ensure ongoing regulatory compliance for customers, Eirgen's regulatory agents, and internal departments.
Act as the primary liaison with Quality Assurance (QA) to ensure seamless regulatory compliance and timely resolution of any compliance issues or audits.
Anticipate compliance challenges and develop practical, innovative solutions to mitigate risks.
Licensing Activities
Manage and coordinate licensing activities for existing Marketing Authorisation Applications across multiple global markets including Europe, US, Japan, Canada, South America, Asia, and the Middle East.
Monitor regulatory changes in these regions and adapt strategies to ensure continuous market access.
Dossier Preparation and Submission Management
Lead the preparation and submission of regulatory dossiers for Eirgen/OPKO target markets.
Maintain strong communication and collaboration with OPKO, Research & Development (R&D), Quality Control (QC), Production teams, and external consultants to ensure dossier accuracy, completeness, and timely submission.
Identify bottlenecks early and implement creative approaches to streamline submission processes.
Strategic Regulatory Planning
Develop and execute long-term strategic plans for regulatory activities aligned with Eirgen's business goals in target markets.
Stay ahead of emerging regulatory trends and leverage insights to create innovative strategies that support product lifecycle management and market expansion.
Think critically and "outside the box" to find new regulatory pathways or solutions that accelerate approvals and reduce time to market.
Leadership and Team Development
Coach and mentor Regulatory Affairs team members, fostering a collaborative environment that encourages problem-solving, continuous learning, and ownership of tasks.
Support team members in developing their skills and resolving issues quickly and effectively, ensuring challenges are met with practical solutions rather than delays.
Promote a "can-do" attitude and resilience within the team, encouraging initiative and accountability.
Problem Solving and Results Orientation
Demonstrate exceptional problem-solving skills by proactively identifying regulatory challenges and bottlenecks, developing innovative and practical solutions to overcome them.
Take ownership of issues and drive them to resolution swiftly, maintaining momentum and ensuring deliverables are met on time.
Foster a results-driven culture within the team that prioritises getting things done while maintaining high standards of compliance and quality.
About You
Minimum of a B.Sc.
degree, preferably in Chemistry, Pharmacy, Pharmacology, or a related scientific discipline.
Candidates with degrees in other science-related fields will also be considered.
At least 10 years of progressive experience in Regulatory Affairs, including significant responsibilities in supervisory or people management roles.
A proven track record of successfully managing regulatory submissions and compliance activities across multiple international markets is highly desirable.
Strong understanding of global regulatory frameworks (e.g., FDA, EMA, PMDA) and experience working within the pharmaceutical or veterinary product sectors.
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 Thursday, 11-December-****.
Direct applicants only.
We are not accepting assistance from recruitment agencies at this time.