ICON Clinical Research

Regulatory Affairs Specialist

Location
London
Salary
Competitive
Posted
06 Jan 2021
Closes
05 Feb 2021
Ref
2JR069659
Discipline
Regulatory Affairs
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)
Regulatory Affairs Specialist

Locations:

UK or Ireland Remote Worker or Office Based (Marlow, Eastleigh or Dublin).

India Office Based only in either Chennai or Trivandrum.

At ICON, it's our people that set us apart. Our diverse teams enable us to become a better partner to our customers and help us to fulfil our mission to advance and improve patients' lives.

Our 'Own It' culture is driven by four key values that bring us together as individuals and set us apart as an organisation: Accountability & Delivery, Collaboration, Partnership and Integrity. We want to be the Clinical Research Organisation that delivers excellence to our clients and to patients at every touch-point. In short, to be the partner of choice in drug development.

That's our vision. We're driven by it. And we need talented people who share it.
If you're as driven as we are, join us. You'll be working in a dynamic and supportive environment, with some of the brightest and the friendliest people in the sector, and you'll be helping shape an industry.

The role:
* Responsible for providing advice and support to the project team for regulatory operations aspects of the projects.
* Manage and ensure maintenance of a positive and productive liaison with internal and external contacts (i.e. regulatory agencies, clients, co-workers, staff, etc.)
* Maintain a strong customer service management approach with clients.
* Lead project teams and advise departments on regulatory standards issues and strategies
* Develop, write, and implement standards and procedures related to regulatory operations.
* Identify client issues and develop alternative strategies for presentation to client consulting with other resources within organization as required
* Participate actively in other business related projects (business opportunities, client specific issues, etc.) and planning.
* Client consultation and preparation of quotes and is responsible for achieving utilization goals of the EU unit.
* Completing other appropriate duties as assigned by line manager that require similar skills

Required experience:

  • Minimum of BS in Life Science, healthcare, engineering preferred
  • Post-graduate certificate in regulatory affairs preferred
  • Minimum of 2 years of relevant experience
  • Understanding of local Health Authority regulations, guidelines, policies
  • Ability to maintain a high level of accuracy and attention to detail
  • Effective project management skills
  • Experience in eCTD, NeeS, Paper Submissions.
  • Experience in Lorenz Docubridge and ISI Tool Box
  • Sequence building and document level publishing
  • Good knowledge on the CTD sections.

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