Job Title:
Associate Director Global Regulatory Affairs
About the Role:
This exciting opportunity has arisen for an Associate Director Global Regulatory Affairs to join our team on a permanent basis.
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
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 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