Associate Director Global Regulatory Affairs
Our client, a leading global pharmaceutical company, is seeking an Associate Director to join their team in a permanent capacity. This role offers flexible hybrid working arrangements.
Key Responsibilities:
* People Management:
o Recruit, develop, and retain a diverse and highly skilled workforce.
o Ensure robust individual training plans and timely completion of required training for direct reports.
o Support talent identification and career development that reflects an end-to-end mindset and demonstrates judgement-based decision making.
o Actively coach and mentor staff on regulatory and labelling process questions.
o Empower staff members to make logical decisions, resolve issues, and execute tasks.
o Manage workload based on portfolio prioritization and address implications to overall resource management and strategies.
o Sponsor a culture of innovation and model inclusivity to ensure diverse voices and ideas are heard and considered.
o Provide mentorship for managers within the team and across the site.
* Regulatory Delivery:
o Align regulatory/labelling strategy with molecule team priorities.
o Seek out information on internal and external customer needs and monitor US and Canadian regulations.
o Remove barriers to ensure accurate, timely, and compliant labelling and regulatory activities.
o Manage global cross-functional communication and issue escalations to ensure alignment on delivery and execution.
o Utilize regulatory and process knowledge to drive decision-making.
o Partner with quality in process improvements and deviation management.
o Provide strategic guidance on regulatory process questions.
o Monitor regulations and the external environment as appropriate.
o Offer technical, administrative, and operational support for regulatory and labelling-related systems.
Requirements:
* Bachelor's degree in a scientific or health-related field (preference).
* At least 5 years of experience in a lead role within the pharmaceutical industry.
* Understanding of regulatory processes and interdependencies among various tasks requiring coordination with cross-functional teams and third parties.
* Proven people management skills.
* Effective communication and motivation abilities.
* Flexibility and strong negotiation skills.
* Strong self-management and organizational skills.
* Able to manage workload, set personal and team priorities, and adjust as needed.
* Problem-solving skills to anticipate and recognize systemic problems, diagnose root causes, and take corrective actions to prevent reoccurrence.
* Ability to coach and develop others.