Associate Director, Regulatory Affairs

Job Title

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; Responsibilities include planning, assigning, and directing work; appraising performance and guiding professional development; rewarding and disciplining employees; addressing employee relations issues and resolving problems; Approve actions on human resources matters, including salary administration;

Independently handles personnel issues, conflict management, defines goals that increase knowledge and skills of staff, and defines staff expectations, without involvement of senior managers;

Assists in the coordination of projects and resources, ensuring quality deliverables to customers;

May contribute to discussions on implementation of business strategy on a regional basis and will set and implement site-specific objectives, as appropriate; Ensures staff have a consistent understanding and positive impression of strategy for regional and global objectives;

May have financial responsibility and accountability for one or more Regulatory Affairs sites; Undertakes business development activities and monitors growth and performance, as required;

May undertake risk analysis and manages the outcome as appropriate;

Builds strong relationships with managers of other operations and acts as a positive ambassador for Regulatory Affairs;

May act as a Project Manager for a large stand-alone programme, 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;

Responsible for leading moderate to significant improvements of processes, systems or products to enhance performance of job area;

Problems faced are difficult and moderately complex, and require detailed information gathering, analysis and investigation to understand;

May be assigned as Reviewer and/or Approver for Regulatory standard operating porcedures or cross-functional standard operating porcedures owned by other operations;

May support global regulatory or technical initiatives or act as a regional representative on a cross-functional initiative;

Performs other duties, as business needs require;

Qualifications

Bachelor's Degree Degree in Lifescience or related discipline Req Or Master's Degree Degree in Lifescience 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;

Possess demonstrated working knowledge of corresponding professional grade level responsibilities, skills and abilities, as required for guidance of staff;

Demonstrate 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 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, communicating this in a positive manner to staff;

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; Possess demonstrated working knowledge of corresponding professional grade level responsibilities, skills and abilities, as required for guidance of staff;

Line management experience required, with demonstrated success in staff development, engagement, and performance;

Ability to manage competing priorities, as appropriate;

Advanced negotiating and influencing skills and the ability to identify and resolve issues, using flexible adaptable approach, Remains calm, assertive and diplomatic in challenging interactions with staff and customers;

Sets a positive example to more junior staff relating to professionalism, positive attitude and communication style to customers and colleagues, Communicates effectively and confidently with various levels of the organization, as appropriate; 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