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Search Results for Regulatory Affairs Manager
Job Title. Location Salary Actions

Senior Regulatory Affairs Specialist

Job title: Senior Regulatory Affairs Specialist – Post market Location: Parkmore, Galway. 1-2 days a week on site Benefits: Top salary, Bonus, pension, healthcare, hybrid working Overview: My client are a fast-paced, rapidly growing medical device company offering a highly differentiated solution in vascular interventions. With a culture of innovation helping each individual develop both professionally and personally, and our culture of respect means that they all work in a collaborative, empowering, and exciting environment. Rep...

Location: Athlone, Clare, Connaught, Galway, Galway City,
Senior Regulatory Affairs Specialist
EU Not Disclosed

Senior Reg Affairs Specialist - Post Market

Job title: Senior Regulatory Affairs Specialist – Post market Location: Parkmore, Galway. 1-2 days a week on site Benefits: Top salary, Bonus, pension, healthcare, hybrid working Overview: My client are a fast-paced, rapidly growing medical device company offering a highly differentiated solution in vascular interventions. With a culture of innovation helping each individual develop both professionally and personally, and our culture of respect means that they all work in a collaborative, empowering, and exciting environment. Reporting to t...

Location: Galway, Galway City,
Senior Reg Affairs Specialist - Post Market
Galway Not Disclosed

Senior Regulatory Affairs Specialist

Job title: Senior Regulatory Affairs Specialist – Premarket Location: Parkmore, Galway. 1-2 days a week on site Benefits: Top salary, Bonus, pension, healthcare, hybrid working Company: My client are a fast-paced, rapidly growing medical device company offering a highly differentiated solution in vascular interventions. This role is best suited to an individual who is self-motivated, accountable and seeking infinite learning and growth opportunities. Role: As a Senior Regulatory Affairs Specialist you will will pl...

Location: Clare, Connaught, Galway, Galway City, Limerick,
Senior Regulatory Affairs Specialist
EU Not Disclosed

Regulatory Affairs Manager Career Profile

Regulatory Affairs Manager


This role is normally suited to someone with a minimum of 5 years in a Regulatory setting, ideally more. Management, departmental budgeting, training are some of the keys tasks involved on the non-technical side of the role.

Key Responsibilities

  • Coordinating, compiling and submitting Marketing Authorisation variations for existing approvals
  • Composing and reviewing Pre-IND information packages and NDA packages for registration of prescription products in the US through the FDA
  • Liaise with partner companies as the primary Regulatory Affairs contact for the company to achieve product registration in all new worldwide regions within projected timeframes
  • Regulatory Affairs European project team leader for all new projects
  • Interpreting EU and US regulatory guidelines and procedures and ensuring the regulatory compliance of the company in all new regions Establish and analyse department budget
  • Identify and recommend areas for cost savings from and Regulatory and compliance perspective
  • Provide Regulatory advice and feedback for all internal company departments and external partners
  • Maintain and apply a high level of awareness and understanding of the impact of existing and future planned regulations
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