Regulatory Specialist

Regulatory Specialist

Full Time Permanent

UK

The Role

Responsible for supporting the regulatory strategy and ensuring compliance with UK and international regulations across the business. This is achieved through hands on management of departmental tasks relating to the regulatory function, alongside the wider business objectives.

Responsibilities

• Assist with the preparation, submission, and maintenance of regulatory documentation,
• Collaborate with management, and other departments within the wider business to achieve set regulatory objectives,
• Support Regulatory processes and provide guidance and feedback,
• Liaise with UK Regulatory Authorities, and the wider business and respond to day-to-day queries and questions,
• Communicate where new, or updated regulatory guidance occurs, ensuring the Regulatory and Quality management team are aware,
• Assist in the development of regulatory SOPs, providing input and expertise,
• Support within displaying a culture of regulatory excellence, ethical conduct, and continuous compliance improvement.

Deliverables

UK PLPI Licences:

• Apply for new product applications upon request from the Commercial department.
• Maintain the existing portfolio, including submission of product variations and ongoing updates to the MHRA PI Call-in list.
• Cancel licences as directed by the Commercial department.

Irish Parallel Import Licences:

• Apply for new product applications upon request from the Commercial department.
• Maintain the licence portfolio, including submission of variations, and perform periodic leaflet and label checks in compliance with HPRA regulations.
• Cancel licences as required.

Product & Import Compliance:

• Ensure compliance with Trademark law in relation to repackaging of parallel-imported products.
• Provide regulatory assessments for label text for imported unlicensed medicines.
• Manage Notification of Imports to the MHRA for unlicensed medicines.
• Submit applications for import/export product licences as needed.

Licensing Oversight & Risk Assessment:

• Support the Regulatory and Quality management team within maintaining a country regulation database to support RP decision-making.

Medical Devices (MedTech):

• Support UK regulatory compliance for medical devices, including adherence to UK MDR and MHRA requirements.

Other Responsibilities:

• Perform additional regulatory duties as reasonably required by the Uniphar Group.
• Provide delegated cover during the absence of colleagues.

Experience

• Minimum of 2 years’ experience in a regulatory role within the pharmaceutical or healthcare industry.
• Solid understanding of MHRA guidelines, particularly relating to Parallel Imports and unlicensed medicines.
• Familiarity with Good Distribution Practice (GDP) requirements and hands-on experience working with Quality Management Systems (QMS).
• Strong IT literacy, with the ability to navigate and understand complex systems, architectures, and digital connectivity.
• Excellent communication skills (both written and verbal), with the ability to engage effectively across departments and with external stakeholders to support regulatory compliance.
• Demonstrated ability to balance regulatory, quality, and commercial priorities to deliver compliant and business-aligned outcomes.
• Skilled in producing clear, concise documentation tailored to various audiences, with strong attention to detail and adaptability in writing style.

Uniphar Background

Uniphar group is a rapidly expanding global healthcare services business with a proud heritage in Ireland.  Since IPO in 2019, the group has grown both organically and through a series of strategic acquisitions, which continues to strengthen Uniphar’s international reach. With a workforce of close to 3000 employees spread across Ireland, United Kingdom, Netherlands, Nordics, and the USA, Uniphar is a trusted global partner to pharma and medtech manufacturers, working to improve patient access to medicines around the world. Uniphar provides outsourced and specialised services to its clients, leveraging the strong relationships with 200+ of the world’s best known pharmaco-medical manufacturers across multiple geographies, enabled by our cutting-edge digital technology and our highly expert teams.  Uniphar is organised into three key divisions; Supply Chain & Retail, Commercial & Clinical Med Tech / Pharma; and Product Access.

Culture at Uniphar

Ethics and integrity sit at the heart of Uniphar’s culture, with our customers and patients integral to what we do and how we do it.  We pride ourselves in being truly entrepreneurial, innovative, collaborative, with a strong problem-solving ethos.  Everything Uniphar does is enabled by our people and as we continue to grow domestically and internationally, we become more diverse.  This diversity fuels our business and culture.