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PharmaLex is a leading provider of Regulatory Affairs, Development Consulting, Pharmacovigilance and 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.

Senior Specialist, Regulatory Affairs


Your Job
  • The role involves providing regulatory advice and the composition of documentation to support developing projects for new and existing clients
  • You will assist the project leaders, managers and the heads in the Regulatory Affairs Department at PharmaLex in all aspects of  project management and in operational tasks, or other tasks as may be assigned
  • A key part of the role will be to evaluate, prepare and compile documents and sections regarding pharmaceutical quality. This could include Active Substance Master Files, application documents for 'Certificates of Suitability', documents for Investigational Medicinal Product Dossier and Quality Overall Summaries/Expert Reports for human and veterinary medicinal products as part of the compilation of the marketing authorisation dossier.  There is a strong emphasis on relevant technical and regulatory requirements and customer specific demands
  • You will 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.

Your Profile
  • You will have a degree in Life Sciences, Chemistry, Applied Biology or Pharmacy, excellent communication and negotiation skills, together with the ability to work independently
  • You should have excellent written and verbal communication skills as well as excellent attention to detail
  • The successful candidate will be fluent in written and spoken English
  • This is an exceptional opportunity for someone with 3-4 years of regulatory experience .

We offer you
  • Open and collaborative organisational culture with emphasis on knowledge-sharing
  • 25 Days holiday plus BH (increasing to 27 after qualifying service)
  • 8% employer pension contribution 
  • An opportunity to work within an organisation with a positive work/life balance environment 
  • Continuous development opportunities through knowledge and experience as well as training.
 
If you are interested in joining our PharmaLex team taking over this challenging job opportunity in our future-oriented company, we are looking forward to receive your application documents stating your earliest possible starting date, any visa requirements and salary expectations on-line.

For further information please don’t hesitate to contact us:

Helen Pietropaolo 
Manager Human Resources UK/ Ireland


Agencies only by prior agreement for the specific job opportunity.