Associate Director Global Regulatory Affairs
Cork, Munster, Ireland
Life Science Recruitment Ltd
Application deadline: 01-05-2025
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Full Job Description
We are seeking an experienced Associate Director of Global Regulatory Affairs for our client, a leading pharmaceutical company. This is a permanent position offering hybrid working arrangements.
Responsibilities:
1. People Management:
* Recruit, develop, and retain a diverse, high-performing team.
* Ensure comprehensive training plans and timely completion of training for team members.
* Support talent identification and career development, demonstrating judgment-based decision making.
* Coach and mentor staff, providing strategic guidance on regulatory and labelling processes.
* Empower staff to make decisions, resolve issues, and execute tasks effectively.
* Manage workload based on portfolio priorities, considering resource management and strategic implications.
* Promote a culture of innovation and inclusivity, valuing diverse perspectives.
* Mentor managers within the team and across the organization.
1. Regulatory Delivery:
* Align regulatory and labelling strategies with molecule team priorities.
* Monitor customer needs and regulatory developments in the US and Canada.
* Remove barriers to ensure timely and compliant regulatory activities.
* Manage cross-functional communication and escalate issues as needed.
* Utilize regulatory knowledge to inform decision-making.
* Collaborate with quality teams on process improvements and deviation management.
* Provide strategic guidance on regulatory processes and monitor external regulatory changes.
* Support regulatory and labelling systems operationally and administratively.
Requirements:
* Bachelor's Degree, preferably in a scientific or health-related field.
* At least 5 years of experience in a leadership role within the pharmaceutical industry.
* Understanding of regulatory processes and cross-functional task coordination.
* Proven people management skills.
* Excellent verbal and written communication skills.
* Strong negotiation, organizational, and problem-solving skills.
* Ability to coach and develop team members effectively.
For more information, please contact Sinéad Cullen.
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