pharmalex_job_career


We are growing, grow with us

Want to work in a dynamic company with daily new challenges and opportunities?  Then is PharmaLex your career opportunity.
 
PharmaLex  is a leading provider of Regulatory Affairs, Development Consulting, Pharmacovigilance, Quality Management and Compliance consultancy services to the pharmaceutical industry.  Regulatory Affairs is a specialist profession within the pharmaceutical industry, built on a unique mix of science and management that ensures companies meet safety, efficacy and quality of drug products required by law.

The success of our company grows with the excellent expertise and the high motivation of our employees. If your profession is not only a job for you but also a mission, and if you enjoy working with people and in teams, then you are highly welcome to join us!

 
We are looking for a talented and enthusiastic person to join our Regulatory Affairs team, to be based in our office in Cornwall (TRAC Services Limited). The role involves providing regulatory advice and the composition of documentation to support developing projects for new and existing clients. You will be able to accurately collate a wide range of scientific information and communicate effectively and responsibly whilst showing strong project management skills.

This is an exceptional opportunity for which no previous regulatory experience is necessary; we have an in-house training program which gives an effective insight and overall understanding of the industry covering the types of activities you will be expected to carry out.

To strengthen our successful team in Cornwall, we are looking, as earliest as possible for a:
 

Regulatory Affairs Specialist (graduate trainee) (m/f/d)

Your Job

Assist the project leaders, managers and the heads in Regulatory Affairs Department at 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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