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Regulatory Affairs Officer

Regulatory affairs officer maidenhead berkshire generics


Your new company
My client is a is an IP focused pharmaceutical manufacturing and marketing company based out of the United Kingdom. Their primary focus is on the European and Australian markets with a longer-term view towards IP respecting geographies.  My client provides a variety of services from IP Licensing to manufacturing to R&D through our UK based facilities or via several global partnerships.  
Your new role

  • Prepare and submit applications of reliable quality in a timely manner to MHRA (UK) via National Procedure. These include new licence applications, variations (including grouping and work sharing), renewals, artwork changes, RFIs, updates and any other relevant applications or notifications.
  • Work with QPPV on PSUR submissions, update SmPC and labelling in line with the Company Core Data sheets.
  • Liaise with regulatory authorities for advice and guidance when necessary, and to resolve issues to achieve the best possible outcome for the business.
  • Maintain up-to-date records and documentation in relation to Marketing Authorisations.
  • Carry out duties in line with regulatory, commercial, quality and business needs and ensuring compliance with regulatory legislation and guidelines, and company processes and procedures.
  • Support other regulatory staff members within the Company when necessary.
  • Assist in preparation of procedures for relevant regulatory activities, and in preparation and review of procedures for other areas.

What you'll need to succeed
  • Pharmacy/Chemistry degree
  • 3-4 years Regulatory Affairs experience
  • Understanding of the current UK and European regulations, laws, guidelines and industry requirements.
  • Exposure to NeeS/eCTD format and electronic submission gateways is preferable.
  • Experience with Generic products and MRP/DCP submissions is advantageous.


What you'll get in return

Competitive salary and benefits.
What you need to do now
If you're interested in this role, click 'apply now' to forward an up-to-date copy of your CV, or call us now.
If this job isn't quite right for you but you are looking for a new position, please contact us for a confidential discussion on your career.


Summary

Job Type:
Permanent
Industry
Pharmaceuticals
Location
Maidenhead
Specialism
Life Sciences
Pay
£28,000 - £32,000
Ref:
3139358
Apply Now

Talk to a Consultant

Talk to Natasha Mankoo, the specialist consultant managing this position, located in London City

107 Cheapside, London, EC2V 6DN

Telephone: 02034650031

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