ASSOCIATE DIRECTOR, REGULATORY AFFAIRS
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Job Reference Number |
13267635 |
Client ID: |
RI/0901812 |
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Posted On: |
May 12 2009 |
Location: |
DUBLIN NORTH |
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Job Type: |
Permanent
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Salary: |
COMPETITIVE |
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Benefits: |
- SUBSIDISED CANTEEN
- STAFF DISCOUNTS
- PENSION / PRSA
- LAPTOP
- MOBILE PHONE
- BONUS
- CAR ALLOWANCE
- PERM. HEALTH INSURANCE
- LIFE ASSURANCE
- VHI
- PAID HOLIDAYS
- EMPLOYEE ASSISTANCE PROG
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When you work for Quintiles you work for the world's leading Pharmaceutical Services Company. We offer product development and commercialisation services to the Pharmaceutical, Biotechnology and Medical Devices industries. Our leading-edge capabilities provide healthcare companies with the potential to bring new medicines/devices through development and registration to the market place more quickly, with supporting medical and drug data that will significantly advance the cost effectiveness and quality of healthcare provision. Recently, of the world’s top 30 best-selling drugs, Quintiles has helped to develop or commercialise every one.The key duties and responsibilities of our current opportunity include –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. • May be assigned as Reviewer and/or Approver for Regulatory SOPs or cross-functional SOPs 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. 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 Ability to exercise independent judgement taking calculated risks when making decisions Sound financial awareness Strong software and computer skills, including MS Office applications Degree in life science-related discipline or professional equivalent* plus at least 6 years regulatory experience including 3 years management experience (*or a combination of education, training and experience)
