Manager, Regulatory Affairs (Europe)

Summary:

The growing need for EU-specific expertise on our development programs as well as to keep the company compliant on emerging EU legislation and processes has led to the need to create a new position based in our Dublin or Uxbridge office. The role is positioned at the Manager/Senior Manager level to enable advanced regulatory input to interactions with EU Regulatory agencies and with our business partners. This role will be focussed on supporting development activities in the area of inflammation and musculoskeletal disease

           Responsibilities:

• Assist Development teams and Regulatory management in developing strategies that are EU-appropriate and take advantage of EU regulatory systems and processes.
  
• Provide leadership on both late and early-stage clinical development related process and strategy to ensure timely study conduct end to end.
  
• Assist clinical teams in study start up and maintenance activities by leading all associated regulatory activities, including but not limited to submissions, addressing agency queries, managing compliance issues.
  
• Provide support on MAA related process and strategy to ensure timely product approvals with competitively differentiated labelling.
  
• As needed, support activity with Business Partners to ensure the EU regulatory strategy meets Company’s business objective.
  
• Monitor emerging legislation and guidance in the EU and contribute to ensuring company-level awareness and compliance (where appropriate).
  
• Build the representation of Company’s EU regulatory function to EMA and EU National Agencies, as well as Alliance partners as required.
  
• Further build Company’s regulatory profile in the EU and serve as a resource for EU knowledge for the global regulatory and development teams.
  
• Conduct those activities as deemed necessary under the leadership of the Director of Regulatory Affairs to support program progression.
  

           Requirements:

• Advanced degree in a scientific discipline.
  
• 5 years regulatory experience with a focus on supporting products through clinical development.
  
• Experience of life-cycle management of approved products in the centralized procedure a distinct advantage.
  
• Experience in dealings with the EMA (scientific advice, orphan designation, PIPs) an advantage.
  
• Previous experience in rare diseases an advantage.
  
• Proven track record of supporting EU Clinical Trial Applications through approval and study start up.
  
• Ability to negotiate and concisely express clear positions to stakeholders at all levels.
  
• Experience of directly working with national regulatory agencies and leading agency meetings face to face.
  
• Excellent written and verbal communication skills.