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ASSOCIATE DIRECTOR, REGULATORY AFFAIRS

 

Company:

BRUNEL RECRUITMENT
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Job Reference Number

13487202

Client ID:

RI/886592
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Posted On:

Jun 17 2009

Location:

DUBLIN, DUBLIN NORTH
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Job Type:

Permanent

Salary:

NEGOTIABLE
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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