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Job Details
Purpose and Contribution summary
Provides strategic leadership and a broad range of Regulatory Affairs consulting and operational services. Leads and develops a team of regulatory professionals comprising direct and indirect reports in the region, ensuring delivery excellence, client satisfaction, employee engagement, and sustainable business growth. Responsible for managing different regional client programs, fostering a high-performance culture, and driving the development of individual and organizational capabilities within the region and beyond as applicable. Supports and contributes to the implementation of the Regulatory Affairs strategy while serving as a role model for leadership, collaboration, and continuous improvement.
Primary Duties and Responsibilities
Strategic and Business Leadership
- Provide strategic regulatory consulting and leadership across complex global, regional and local regulatory programs.
- Enable high-quality client service delivery aligned with business objectives
- Support regional workforce planning, resource visibility, and capacity discussions in collaboration with the Global organization
- Drive growth through client development, cross-selling, proposal management, and support in business development initiatives.
- Support the development and execution of Practice Area strategies, objectives, and annual business plans.
- Contribute to regional operational effectiveness by supporting resource planning, utilization visibility, capability development, and escalation of people or capacity risks.
- Contribute to financial performance through effective resource planning, budget management, and operational oversight.
- Identify opportunities for innovation, efficiency improvements, and service expansion.
- Provide a wide range of flexible services within regulatory affairs, includes providing strategic input and navigating clients through the processes in addition to the hands-on activities required to prepare and submit documentation.
- Maintain regional oversight of team capability, availability, development needs, and readiness to support regulatory delivery
- Participation in, and leadership of, regulatory processes to gain and maintain marketing authorizations for human and veterinary medicinal products (applications, renewals, variations) including medical devices, cosmetics, food supplements and herbal products.
- Preparation, review and compilation of documents within the framework of regulatory affairs projects.
- Communication with clients and Health Authorities.
- Responsible for scientific advice procedures
Team Leadership and People Development
- Provide regional line management leadership for assigned regulatory professionals, ensuring clear expectations, consistent people processes
- Lead, manage, and develop a team of regulatory professionals, fostering an inclusive, collaborative, and high-performing culture within the team and beyond in collaboration with other regions and regulatory departments.
- Provide clear direction, coaching, mentorship, and ongoing feedback to team members to support professional growth and career progression.
- Conduct regular performance and development discussions and support employees in establishing meaningful career development plans.
- Participate in staffing discussions from a line management perspective by advising on employee capability, development needs, availability, and…