Senior Regulatory Specialist

In this role you will be supporting the Regulatory Affairs Healthcare Team with implementation, execution and management of pharmaceutical regulatory activities in UK and further European regions, ensuring compliance and growth of our medicinal product portfolio.

The position could be based in our Ecolab Ltd. (Northwich) or near our Offices in Caerphilly or Baglan - hybrid working model optional.

How you'll make an impact:

This position contains tasks related to pharmaceutical regulatory area.

• Support Cross-Functional European Projects to drive innovation and efficacy

• Manage diverse maintenance activities of Medicinal Product Licenses (e.g., UK, IE) and export market, like:

• Preparation and submission of variations
• Creation and revision of packaging & promotional materials
• Update of internal and official databases
• Support audits & inspections

• Support the Pharmacovigilance system
• Monitor regulatory/pharmaceutical regulations for the relevant therapeutic areas and share information internally
• Assist other functions, like customer service and tender business with regulatory expertise

Education:

• Bachelor’s degree or equivalent, preferably in life sciences (pharmacy, biology, or similar). 

Qualifications:

• Experience (minimum 2 years) of being in a similar position in the pharmaceutical industry or at health authorities
• Good knowledge of applicable pharmaceutical regulations – preferably with UK & EU registration procedures
• Basic knowledge of related ethical code of practice required for GXP compliance 
• Strong written and verbal communication and organizational skills 
• Ability to work independently and collaborate effectively with cross-functional colleagues at all levels of the organization. 
• Ability to multi-task and prioritize work. 
• Fluency in English (speaking, reading, and writing) 
• Proficiency in Microsoft applications (Excel, Word, PowerPoint)