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Regulatory Affairs Manager – Post Marketing – Global CRO – Remote (Czech Republic) £negotiable, bonus + various other benefits

A global CRO are currently recruiting for a Regulatory Affairs Manager to focus on all post marketing activities for a global pharmaceutical client.

The Company

This is fantastic opportunity to work for a global, market leading CRO in their regulatory team. Pioneers in human and data science, this CRO is at the forefront of clinical trials across multiple therapy areas.

  • Global CRO, one of the front runners in clinical trials
  • Covering multiple therapy areas (Oncology, Rare Diseases, GI, CNS being just a few of them)
  • Hugely successful company who have a consistent and exciting project pipeline
  • Highly supportive company, they’ll work with you and support you in achieving career goals

The Role

You’ll be managing a range of post marketing activities for a leading pharmaceutical client mainly on a national basis with the relevant authorities in Czech Republic.

  • Manage the local regulatory submission preparation in collaboration with internal and external stakeholders
  • Submit renewals/ variations/ new applications filings/ MAH transfers to the local Health Authority, and follow up on the local regulatory approval process for designated countries
  • Preparation of local Product Labelling (e.g., SmPC, PIL), in local language for designated countries
  • Artwork review and approval in client systems

You

To apply for this role as Regulatory Affairs Manager – Post Marketing our client is hoping for someone with the following skills and experience

  • Ample post marketing Regulatory Affairs experience within a CRO or Pharmaceutical company
  • Must have local experience within Czech Republic. Global regulatory knowledge is a bonus but not essential
  • Experienced in preparing variation, renewal packages and artwork approvals locally in Czech Republic
  • Strong stakeholder management skills

What should you do next?

This Regulatory Affairs Manager – Post Marketing role is one not to be missed; it encompasses the opportunity to work for a global CRO with one main pharmaceutical client. To discuss this Regulatory Affairs Manager – Post Marketing role further or to find out about other Regulatory Affairs jobs I’m currently working on, please get in touch or hit apply to submit your current CV.

Unless otherwise stated, if applying for a job within the UK or European Union, you must ensure that you are already authorised to work there.

Carrot Pharma Recruitment Ltd acts as an Employment Business and an Employment Agency on behalf of our client in recruitment for this role.

Apply Now!

Job Consultant

Hayley Shayestehroo

Regulatory Affairs

Senior Consultant

hayley@carrotpharma.co.uk

01625 361072

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