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Sinead Cullen
Life Science

01 507 9252
[email protected]
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Details

Associate Director Global Regulatory Affairs


Reference:SCA014363 Location: Cork
Qualification:DegreeExperience:7-9 Years
Job Type:PermanentSalary: Not Disclosed
May be suitable for: Regulatory Affairs, Regulatory Affairs Clinical Research, Regulatory Affairs Manager, Regulatory Affairs Specialist

Associate Director Global Regulatory Affairs
Our client, a global pharma company, are 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 mindsetand demonstrates judgement-based decision making
  • Actively coach and mentor staff, including providing strategic guidance to staff on regulatory andlabelling 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 resourcemanagement and strategies
  • Support and encourage a culture of innovation and model inclusivity to ensure diverse voices andideas 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 andCanadian regulations
  • Remove barriers to ensure labelling and regulatory activities are completed accurately, timely, and incompliance 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 requirecoordination among cross-functional team members and possibly third parties
  • Experienced people manager
  • Demonstrated ability to communicate effectively (verbally and written) and to motivate and inspireothers
  • 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 rootcauses and take corrective actions to prevent reoccurrence
  • Proven ability to coach and develop others

For more information please contact Sinéad Cullen on +353879500821 or [email protected]