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Head of Regulatory Affairs & Quality

£Negotiable dependent on experience | North West |  Regulatory Affairs, Pharmaceutical Company/Sponsor side, Regulatory Consultancy |  Permanent  | Ref:890121

The Role

Head of Regulatory Affairs & Quality - Pharma - Leading Pharma Company - North West - £ Excellent basic salary benefits, WFH

The Head of Regulatory Affairs & Quality will be responsible for all regulatory and quality matters for the business. This will include managing the relationship with regulatory bodies, managing regulatory compliance, regulatory intelligence, and quality management.

 

The Company

This is an exciting time to join an expanding, highly successful healthcare consultancy based at their office in Cheshire. Offering consultancy and capability services to pharma companies in the UK & EU, this is a great role to be able own and define the day to day regulatory activities of the business.

  • Global, leading healthcare company
  • Remote working for part of the week (once settled into the role)
  • Great career opportunities

 

The Role

The Head of Regulatory Affairs & Quality will be responsible for managing a complex and diverse set of regulatory requirements across multiple markets.

  • Manage a complex set of regulatory requirements across the business portfolio
  • End to end delivery of product dossiers and technical files
  • Reclassification applications for change of legal status (POM to P and P to GSL)
  • Regulatory intelligence
  • Own the quality management system

 

You

To apply for this role as a Head of Regulatory Affairs & Quality our client is hoping for someone with the following skills and experience;

  • Extensive regulatory experience, currently at Manager / Senior Manager level and good experience dossier/technical file creation and registrations
  • UK / EU OTC experience
  • Excellent communication skills gained within a cross function role
  • A high level of self-motivation and drive, with proven visible success
  • Knowledge or experience of Switch Procedures (POM to P or P to GSL)

 

What should you do next?

This Head of Regulatory Affairs & Quality role is one not to be missed; it encompasses the opportunity to work in a growing healthcare company who are at the forefront of their industry. To discuss further, please submit your current CV.

Unless otherwise stated, if applying for a job within the 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.

Consultant

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Hayley Shayestehroo

Which team and area do you work/specialise in?

I work in the Regulatory Affairs team and recruit for Regulatory Affairs professionals at all levels within Pharma, Medical Devices companies and Regulatory Consultancies

What are some of the typical roles you cover?

I cover Regulatory Affairs positions at all levels within Pharma, Medical Devices and Regulatory Consultancies, these typically include;

Regulatory Affairs Associate jobs, Regulatory Affairs Executive jobs, Regulatory Affairs Senior Associate jobs, Regulatory Affairs Manager jobs, Regulatory Affairs Senior Manager jobs, Regulatory Affairs Director jobs, Regulatory Affairs Consultant jobs, Regulatory Writer jobs and Medical Writer jobs.

What are the hot issues in your sector currently?

Within Medical Devices it is the transition from MDD to MDR in May 2020. A lot of medical device companies are hiring Regulatory professionals to prepare their company for the transition

What’s makes you #DistinctlyDifferent?

I take pride in getting to know my candidates on a personal level as well as professional. Changing jobs is a big decision for most people so I like to ensure I am placing my candidates in a role that not only matches their career aspirations but also suits their personal situation and key motivations.

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