Regulatory Affairs Specialist (graduate trainee)

Advertiser
TRAC Services Limited
Date Posted
8th December 2018
Reference
591891883
Sector
Healthcare, Socialcare & Medicine
Location
Cornwall
Salary
Negotiable
Assist the project leaders, managers and the heads in Regulatory Affairs Department at TRAC/PharmaLex in all aspects of project management and in operational tasks, or other tasks as may be assigned:
  • Support with preparation of documents within the framework of regulatory affairs projects in Europe (CP, MRP, DCP, renewals, variations, and country-specific procedures) and outside Europe in agreement with projects leads
  • Support with project work for clients (e.g. compilation, preparation and reviewing of documents) after adequate instruction and/or guidance
  • Preparation and handling of internal and external correspondence
  • Organization of and participation in training sessions, meetings, client visits etc.
Assist in optimizing and monitoring internal departmental organization:
  • Maintain internal departmental templates
  • Assist the project managers in project planning and organization
  • Assist the managers, heads of regulatory department and regulatory affairs teams
We offer you
  • Diversified and challenging job
  • Cooperating partnership and leeway
  • Flexible working hours
  • Continuous development opportunities through knowledge and experience as well as training
Your Profile
  • Degree in Life Sciences, Chemistry, Applied Biology or Pharmacy
  • Experience/knowledge of area of activity or similar field
  • Ability to work independently
  • Ability to acquire and apply knowledge "on-the-job"
  • Ability to work according to project plan and identify/escalate potential issues according to agreed communication plan
  • Structured way of working; may determine priorities with general supervision
  • Resolves routine (and some non-routine) problems in a thorough, constructive and timely manner
  • Attention to detail and high service orientation
  • Ability to prioritize and manage own time and tasks
  • Good communication skills (written and verbally); capability to point out issues and provide potential options for solution in the area of expertise
  • Good negotiation skills
  • Confident appearance/self-presentation

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