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Regulatory Affairs Specialist

1 month ago

Runcorn, Halton, United Kingdom Radiant Systems Inc Full time
Job Summary

We are seeking a highly skilled Regulatory Affairs Specialist to join our team at Radiant Systems Inc. The ideal candidate will have a strong background in regulatory affairs, with experience in managing regulatory activities and strategies for assigned projects.

Main Responsibilities:

  • Oversee and take ownership for Regulatory activities and strategies for assigned projects and preparation and submission of new UK and IE Marketing Authorisation Applications for New Chemical Entities, Generics/Hybrids, devices, biosimilar and OTC products
  • Ensure high quality data and standards are used in support of all regulatory applications
  • Full lifecycle management of product allocation, including support of new product launch activities for both UK and IE
  • Dossier Risk Assessment (Due Diligence)
  • Work proactively with internal and external stakeholders (e.g. MHRA and HPRA) to ensure work is prioritized in accordance with business needs
  • Mentoring and training of other regulatory professionals as required

Requirements:

  • Pharmacy/Chemistry or Life Sciences degree
  • Experience in regulatory affairs in pharmaceuticals
  • Demonstrated experience of contact, relationship and working with MHRA and HPRA
  • Substantial regulatory new submission and post approval submissions experience for a wide range of dosage forms including generics, new chemical entities, devices and OTC products
  • A working knowledge and experience in CTAs, paediatric investigation plans and orphan designations
  • Regulatory strategy development with a focus on bringing innovative solutions to project teams and health authorities
  • Risk assessment and project management skills

What We Offer:

  • A dynamic and fast-paced work environment
  • The opportunity to work with a broad range of internal and external customers across complex projects
  • A competitive salary and benefits package