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Regulatory Affairs Professionals

Job Description
With 8 offices around the globe, we are the world’s largest Regulatory Affairs Consultancy, working with the majority of the top 20 Healthcare Organisations.

Our success is built on our reputation, and building strong client relationships. We provide quality Regulatory Affairs Professionals on-site and provide remote Regulatory Affairs assistance for business critical projects, ensuring and surpassing tight timelines and budgets.

With unprecedented success and the securing of multiple ongoing projects, we are now looking for Regulatory Professionals to join us on a permanent basis.

We offer an excellent opportunity to work with a variety of clients on diverse projects, from Development through to Post-Approval depending on your skill set, either based at our Head Office in Maidenhead or on client site.

Skills/Experience Required
We are looking for mid to senior level Regulatory Affairs Professionals with some or all of the following skills:-

- CMC (gap analysis, module revision, DMF’s)
- Clinical/Development experience
- MRP, DCP, CP, National Licences
- eCTD publishing, PSUR’s, NDA’s
- Labelling, SmPC compliance, PIL’s

You will have excellent attention to detail and commercial acumen along with adaptability and flexibility. The ability to travel locally within the South East if necessary is a pre-requisite.

These are exciting and diverse roles where you will gain exposure to a variety of projects along with training and development to progress your Regulatory skill set.

Location
UK

Client
Pharmalink Consulting

Job Type
Full Time, Employee



Interested? Apply Now.


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  10. Relevant Skills
  11. Prescription Drugs*
  12. Biotech*
  13. Devices*
  14. OTC*
  15. Generics*
  16. CMC eg review/preparation of QOS*
  17. Manufacturing compliance*
  18. Audit work eg CMP, GLP, GCP*
  19. Clinical eg review of protocols, IB, CSRs, Module 2 & 5 documents*
  20. Postmarketing maintenance eg variations/sNDA, postmarketing commitments/safety reporting*
  21. Regulatory operations eg CTD/eCTD/dossier preparation*
  22. Original NDA/MAA filings*
  23. Labeling*
  24. Advertising and promotion*
  25. Regulatory strategy eg RA meetings, filing strategy*
 


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