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

• 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

• 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