Associate Director Global Regulatory Affairs

5 days ago

Cork, Cork, Ireland Life Science Recruitment Ltd Full time
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 and Canadian 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: Bachelors 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 or

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