Manager Regulatory Affairs

About the Company

About the Position

The Regulatory Affairs Manager will play a key role in global operations. You will work as part of the Global Submissions team. This is a standalone role (no direct reports). 

Key Responsibilities

• To support the development of the submission plan
• To collaborate cross-functionally
• To effectively complete submissions 
• To manage and support Regulatory systems and processes 
• To track the progress of all aspects of a regulatory submission dossier

Experience/Requirements

• BSc, MSc or related
• 5+ years Regulatory Affairs experience (Pharma or Biotech)
• Global submissions experience - essential
• Excellent Project Management experience - essential
• Ability to represent the company at a Global level
• Strong communication and interpersonal skills
• Ability to work within a highly skilled and experienced team, work cross functionally with other departments and up-skill and train new hires as the function expands
• Strong IT skills
• Strong problem solving skills

Remuneration Package

• Excellent Base Salary
• Generous Bonus
• Healthcare
• Pension
• Flexibility to work in a hybrid model in Dublin or 100% from home
• Collaborative culture
• Excellent career development opportunities

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