Job Board

Regulatory Affairs CMC Specialist

Job Description
Pharmalink Consulting has an immediate need for a Regulatory Affairs CMC Specialist. The major responsibilities include: prepare and update the CMC sections of global Marketing Authorizations; develop regulatory post-approval filing strategies and variations for global products; ensure support to market affiliates for license renewals and annual reports, line extensions and territory expansions; ensure that all regulatory documents are prepared accurately, completely and on-time; manage completion of compliance assessments on product dossiers and develop and implement specific filing strategies to ensure compliance of registered commitments and site manufacturing/testing practice.
This project will take place at the client site in Central NJ. Relocation will be considered but candidates need to be available immediately for interview and starting.

Requirements
The key requirements for this project are:
5 years of CMC focus
Global Experience especially the EU
Proven Writing Skills
Post-Approval Emphasis
MS degree or higher in the Life Sciences

Location
Central New Jersey

Client
Global Pharmaceutical Company

Job Type
Full Time Consultancy



Interested? Apply Now.


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


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