Associate Director Global Regulatory Affairs

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

#J-18808-Ljbffr Compliance & Regulatory Affairs