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Senior Regulatory Affairs Professional

Ref: 77364

  • Negotiable
  • 22 Jun 2022
  • Dublin (Central)
  • Permanent

Senior Regulatory Affairs Professional 100% Remote 

About the Company

My client are a Global Healthcare company who focus on the development and manufacture of products for global supply.  

About the Position

Reporting to the Director of Regulatory Affairs, you will work as part of my clients Irish Regulatory function to support global regulatory activities. 

Key Responsibilities
  • To review registration dossiers for all marketed products
  • To prepare, compile, validate and submit eCTD registration dossiers
  • To provide project-specific Regulatory Strategic advice, technical expertise and coordination oversight for assigned projects
  • To support the compilation of regulatory component of annual product quality reviews
  • Collaborate with the Drug Safety team to ensure timely submission of PSURs, safety variations and other requests as required
  • To provide regulatory assessment of change controls

Experience/Requirements

  • BSc, MSc or related
  • 4+ years Regulatory Affairs experience (within Pharma or Medical Devices space)
  • EU submissions experience - essential
  • Medical device / combination products experience 
  • Strong communication and interpersonal skills
  • Ability to work within a highly skilled and experienced team and work cross functionally with other departments
  • Strong problem solving skills
  • Eligible to live and work in Ireland - role can be 100% remote 

Remuneration Package

Excellent Salary + Benefits on offer with this role. Base salary will depend on experience and skills. 
Contact
For more information on this role or any other Life Sciences roles contact Gillian McMurrough contact 01 5927883 or +353871213548 or email or click on the apply button below.