Associate Director Global Regulatory Affairs
Associate Director Global Regulatory AffairsOur 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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