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Associate Director, Regulatory Affairs
by Donal O'Donoghue in Dublin North
Our Client is a global pharmaceutical services company, which offers product development and commercialisation services to the Pharmaceutical, Biotechnology and Medical Devices industries. Its leading-edge capabilities provide healthcare companies with the potential to bring new medicines/devices through development and registration to the marketplace more quickly, with supporting medical and drug data that will significantly advance the cost effectiveness and quality of healthcare provision.
Job Description:
- Manage staff in accordance with organizations 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.
- 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.
Roles / Responsibilities:
- 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.
Skills / Experience:
- 6 years regulatory experience including;
- 3 years management experience
Education / Professional Qualifications:
- Degree in life science-related discipline or professional equivalent
Personal Attributes:
- 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.
- Ability to exercise independent judgement taking calculated risks when making decisions.
- Sound financial awareness
Published at 10-06-2009
Viewed: 65 times
Viewed: 65 times