Job Board

Associate Director, Regulatory Affairs

With offices around the globe, Pharmalink Consulting are the world’s largest Regulatory Affairs Consultancy, working with the majority of the top 20 Healthcare Organizations.
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.
Due to the overwhelming success of Pharmalink Consulting’s presence in the USA, we are looking for an Associate Director to join our expanding team.

Job Description
With a wealth of regulatory expertise, preferably European alongside US, you will have worked at a senior level, providing both strategic regulatory advice alongside working in a ‘hands on’ capacity. Your role will be diverse, assisting the Director of Regulatory Affairs in Regulatory projects alongside your own, and utilizing your commercial acumen to prepare proposals, visit clients and interview potential Pharmalink employees.

You will have excellent communication skills and have the ability to liaise at all levels to forge new client relationships and develop existing ones. This is a new and exciting role, in which you will be able to expand your existing Regulatory skills in a variety of different projects.

Essential Criteria
Extensive Regulatory Affairs knowledge, preferably EU & USA. CMC, pre & post submission, MA, ANDA, Project Management skills.

Location
Short Hills, NJ

Client
Pharmalink Consulting Inc

Job Type
Permanent



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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