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International Pharma Company - Head of Regulatory Affairs - NRW

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Location Nordrhein-Westfalen, Deutschland Salary k.A.
Sector Life Sciences Type Permanent

Are you looking for a new challenge in an important and strategic role for an international pharmaceutical company?

Do you have experience as a head of regulatory affairs or as a regulatory team lead?

Then please read the job description below:

For my customer, an international pharmaceutical company with offices in NRW, I am currently looking for a Head of Regulatory Affairs.

In this role you will be responsible for overseeing all activities related to the marketing authorisation of a product that is currently being transferred to the company. The head of regulatory affairs' main responsibilities will be to oversee the outsourced and in-house functions working to maintain the marketing authorisation. They will also be the main point of communication with the relevant European health authorities.

Outsourcing Management:

  • Manage outsourced and in-house functions in order to ensure compliance to relevant European regulations and requirements as well as defined service standards. The functions encompass:
    • Regulatory affairs
    • Product quality assurance
    • Pharmacovigilance Manufacturing and logistics
  • Set-up the outsourcing of required functions in collaboration with corporate departments (legal and/or HR) and define quality and performance indicators for each function
  • Monitor and report on any non-compliances, risks and issues related to the outsourced functions

Health Authority Communication and Reporting:

  • Responsible for timely and accurate communication with the relevant health authorities in Europe
  • Regular reporting to the headquarters on all relevant topics
  • Ad-hoc reporting in case of non-compliances

Management of Systems, Processes and Capability:

  • Define and drive the implementation and optimization of:
    • Required systems (e.g. PV Master File), with the support of the relevant PV roles
    • Processes and their documentation (e.g. Standard Operating Procedures, KPIs/ KQIs)
    • Training
  • Update above in line with new regulatory requirements with the support of the Regulatory Affairs roles

Long-term strategy:

  • Develop a long-term strategy to integrate the marketing authorisation relevant roles into the business and gain approval from the company's headquarters
  • Implement long-term strategy by recruiting relevant roles in collaboration with corporate functions

This is an exciting opportunity to work for an international pharmaceutical company with innovative products.

This position requires a highly motivated and driven individual, who would like to recruit and develop a team of regulatory experts.

The next step:

If you are interested in this position and would like to apply, then please send me your CV and salary expectations.

Andrew Pride - Principal Consultant Regulatory Affairs

a.pride(at)progressive.de

T: +49 (0) 89 - 551 977 67

Progressive München - Pharma