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Associate Director Global Regulatory Affairs

4 weeks ago

Cork, Cork, Ireland Life Science Recruitment Full time
Associate Director Global Regulatory Affairs

Associate Director Global Regulatory Affairs
Our client, a global pharma company, is currently recruiting for an Associate Director Global Regulatory Affairs to join their team on a permanent basis. People management experience is essential for this role. This role offers hybrid working.

Responsibilities:

People Management:

  • Recruit, develop, and retain a diverse and highly capable workforce
  • Ensure robust individual training plans and timely completion of required training for direct reports
  • Support and enable talent identification and career development that reflects an end-to-end mindset and demonstrates judgement-based decision making
  • Actively coach and mentor staff, including providing strategic guidance to staff on regulatory and labelling process questions
  • Empower staff members to make logical decisions, resolve issues and execute tasks
  • Manage workload based on portfolio prioritization and address implications to overall resource management and strategies
  • Support and encourage a culture of innovation and model inclusivity to ensure diverse voices and ideas are heard and considered
  • Provide mentorship for the managers in the team and across the site

Regulatory Delivery:

  • Align regulatory/labelling strategy with molecule team priorities
  • Actively seek out information on the needs of internal and external customers and monitor US and Canadian regulations
  • Remove barriers to ensure labelling and regulatory activities are completed accurately, timely, and in compliance with regulatory and quality system requirements
  • Manage global cross-functional communication and issue escalations to ensure alignment on delivery and execution
  • Utilize regulatory and process knowledge to drive decision-making
  • Partner with quality in both process improvements and deviation management
  • Provide strategic guidance to staff on regulatory process questions
  • Monitor regulations and the external environment as appropriate
  • Provide technical, administrative and operational support for regulatory and labelling-related systems

Requirements:

  • Bachelor's Degree, preferably in a scientific or health-related field
  • Previous experience, preferably 5 years in a lead role in the pharmaceutical industry
  • Must understand regulatory processes and the interdependencies of various tasks that require coordination among cross-functional team members and possibly third parties
  • Experienced people manager
  • Demonstrated ability to communicate effectively (verbally and written) and to motivate and inspire others
  • Demonstrated flexibility and strong negotiation skills
  • Strong self-management and organizational skills; able to manage workload, set personal and team priorities and adjust as needed
  • Strong problem-solving skills: able to anticipate and recognize systemic problems, diagnose root causes and take corrective actions to prevent reoccurrence
  • Proven ability to coach and develop others

For more information please contact Sinéad Cullen on +353879500821 or sinead.cullen@lifescience.ie

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