Senior Regulatory Specialist

Responsibilities

• 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

Requirements

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

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