Regulatory Affairs Project Manager

  • Location:

    Leeds, West Yorkshire

  • Sector:

    Scientific

  • Job type:

    Permanent

  • Salary:

    Negotiable

  • Contact:

    Jasdeep Panesar

  • Contact email:

    Jasdeep.Panesar@search.co.uk

  • Job ref:

    Req/523707

  • Published:

    6 months ago

  • Expiry date:

    2020-02-21

  • Start date:

    ASAP

Regulatory Affairs Project Manager

Are you looking for a challenging career within Regulatory Affairs? Do you have experience dealing with CMC Regulatory Compliance?

I am working in partnership with a leading global Pharmaceutical organisation that is looking for an experienced Regulatory Affairs Project Manager to join the team.

Reporting to the Portfolio Lead, you will work cross-functionally in project managed teams, providing guidance and support to the R&D and other internal teams to help facilitate the development of new medicines with support from the functional lead.

You will write Modules 1 and 3 of the dossier and take responsibility of the registration procedure, to ensure timely submission, responses and grant across Europe and beyond

You will have experience of writing and submitting new MA application with detailed CMC knowledge, some knowledge of the formulation development process would also be an advantage and an understanding of bioequivalence.

You will have knowledge of European Regulatory requirements, in particular, generic submission categories and how to apply this knowledge in a practical way.

For more information or if this opportunity is of interest then please apply!

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