Description
Regulatory Specialist
About VLE Therapeutics
Powered by transformation research in APC, VLE Therapeutics Ltd was formed to extend the value chain and deliver science and digital led manufacturing of Vaccines and Advanced Therapeutics.
VLE Therapeutics will support GMP clinical manufacturing of advanced therapeutics and aims to transform the time and cost associated to produce medicines for our clients. This will be the first Irish-owned facility expressly designed to provide Ireland and Europe with a local supply chain for these critical medicines.
To create the best client experience, we will create & implement a seamless handover process from APC process development into GMP manufacturing, leveraging our novel platforms to deliver as a Medicine Accelerator. This is a unique opportunity for the successful candidate to become involved in ATMP and related pharmaceutical developments.
Principal Responsibilities:
- Reporting to the Head of Quality, this is a client and regulatory agency facing role
- Ownership of client regulatory projects, working within a team of SMEs to deliver a regulatory roadmap for client projects including new products and variations to existing filings
- Preparation, review and approval of client regulatory deliverables
- Develop the regulatory strategy to support registration and/or renewal.
- Collaborate with colleagues across the business and in external
- companies to identify data requirements for product registration/renewal.
- Report on project progress
- Monitor the progress of the evaluation and ensure all regulatory queries are addressed in a timely fashion
- Be subject matter expert (SME) on the legislation and guidelines in the territory / territories which you are assigned to work in.
- Collaborate with the VLE team members at relevant meetings and proactively communicate with the team members and/or departments on issues.
- Development & ongoing evaluation of regulatory training programme and training delivery
- Assist with project management of VLE regulatory activities and proactively identify & implement improvement projects.
Experience & Qualifications
Essential
- Primary Degree in scientific discipline or equivalent
- Relevant post-graduate qualification an advantage Regulatory professional with minimum 3 years' experience in Pharma / Biotech Regulatory Affairs
- Knowledge of regulatory frameworks for advanced therapies
- Experience in responding to health authority queries
- Demonstrated ability to operate within cross-functional teams
- Effective organisational skills and ability to work independently
- Ability to present clear and concise written arguments to support a specific regulatory or scientific position on a topic.
- Excellent attention to detail is essential for this role.
- Excellent project management & organisational skills with the ability to multi-task and work in an environment with shifting priorities.
- Strong written and verbal communication skills with the ability to liaise with regulatory authorities and internal stakeholders.
How to apply:
Suitable applicants should submit a CV and Cover Letter. Please note that the closing date for applications for this position is 31ST May 2025
VLE is committed to the principle of equal opportunity for all employees. All employment decisions at VLE are based on business needs, job requirements and individual qualifications, without regard to gender, ethnicity, age, religious belief, disability, sexual orientation, gender identity and/or expression, marital status, or any other status protected by Irish law.
Salary
Negotiable