Regulatory Affairs Specialist (graduate trainee)

  • Job Reference: J249
  • Date Posted: 29 November 2018
  • Recruiter: TRAC Services Limited
  • Location: Redruth, Cornwall
  • Salary: On Application
  • Sector: Healthcare & Medical
  • Job Type: Permanent
  • Work Hours: Full Time

Job Description

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