Associate Director, Regulatory Affairs

Job Overview

Line Management responsibilities for a team of Regulatory staff or may be responsible for the performance of one or more Regulatory Affairs sites. Responsible for the development of regulatory business, in accordance with Global Regulatory Affairs business plans. Participates in project-related work, as necessary.

Essential Functions

• Manage staff in accordance with organization's policies and applicable regulations; planning, assigning, and directing work; appraising performance and guiding professional development; rewarding and disciplining employees; addressing employee relations issues and resolving problems; approving actions on human resources matters, including salary administration
• Independently handle personnel issues, conflict management, define goals that increase knowledge and skills of staff, and define staff expectations without involvement of senior managers
• Assist in the coordination of projects and resources, ensuring quality deliverables to customers
• Contribute to discussions on implementation of business strategy on a regional basis and set and implement site-specific objectives
• May have financial responsibility and accountability for one or more Regulatory Affairs sites; undertake business development activities and monitor growth and performance
• May undertake risk analysis and manage the outcome as appropriate
• Build strong relationships with managers of other operations and act as a positive ambassador for Regulatory Affairs
• May act as a Project Manager for a large stand-alone program involving several regulatory or technical deliverables and/or region and/or operation; may provide strategic regulatory and/or technical consultancy on a variety of projects
• May manage meetings with Regulatory Agencies
• May write and/or review a complete single service regulatory proposal and defend costs and timelines to clients
• May plan and deliver workshops or presentations on Regulatory Affairs topics for conferences or publications
• Lead moderate to significant improvements of processes, systems or products to enhance performance of job area
• May be assigned as Reviewer and/or Approver for Regulatory standard operating procedures or cross-functional standard operating procedures owned by other operations
• May support global regulatory or technical initiatives or act as a regional representative on a cross-functional initiative
• Perform other duties as business needs require

Qualifications

• Bachelor's Degree in Life Science or related discipline required, or Master's Degree in Life Science or related discipline
• At least 6 years regulatory experience including 3 years management experience (or a combination of education, training and experience)
• Possesses a specific regulatory or technical expertise
• Good, solid interpersonal communication (oral and written) and organization skills
• Strong software and computer skills, including Microsoft Office applications
• Demonstrates negotiation skills and is confident in making decisions with minimal supervision
• Ability to work on several projects, retaining quality and timelines
• Demonstrated working knowledge of corresponding professional grade level responsibilities, skills and abilities as required for guidance of staff
• Demonstrated success in leading teams or previous experience in a supervisory capacity
• Advanced negotiating and influencing skills and the ability to identify and resolve issues using a flexible adaptable approach; remains calm, assertive and diplomatic in challenging interactions with customers
• Sets a positive example to staff relating to professionalism, attitude and interaction with colleagues and customers
• Understands and promotes Corporate and Global Regulatory Affairs Business Unit strategies
• Ability to provide fair, timely, appropriate and constructive feedback and guidance to staff
• Ability to earn trust of staff, acting in confidence and with sensitivity when dealing with personnel issues, staff expectations and conflict management
• Demonstrates confidence and appropriate communication style in representing staff issues or concerns to senior management
• Line management experience required, with demonstrated success in staff development, engagement, and performance
• Ability to manage competing priorities as appropriate
• Communicates effectively and confidently with various levels of the organization; remains motivated and enthusiastic in times of change and other pressure situations
• Possess practical knowledge in leading and managing the execution of processes, projects and tactics within one department or multiple related departments
• Ability to exercise independent judgement taking calculated risks when making decisions
• Applicable certifications and licenses as required by country, state, and/or other regulatory bodies