Regulatory Affairs Officer

  • Location

    Cheadle, Cheshire

  • Sector:

    Engineering

  • Job type:

    Permanent

  • Salary:

    £35000 - £40000 per annum

  • Contact:

    Stacey Davies

  • Contact email:

    Stacey.davies@experis.co.uk

  • Job ref:

    BBBH114691_1574186300

  • Published:

    10 months ago

  • Expiry date:

    2019-12-19

  • Client:

    #

REGULATORY AFFAIRS OFFICER

CHEADLE

£35,000 - £40,000 + BENEFITS

Full benefits package includes - Bonus Scheme, Contributory pension scheme, Private Health, Private Dental, 25 days annual leave

Why Recruiting?

A world leading pharmaceutical manufacturing company who are supporting companies in taking their products from early development through to commercial manufacturing. Working closely with external clients throughout the entire product life-cycle to deliver innovative solutions.

The Job

You will prepare, review and authorise CMC (Module 3) documents using primary source manufacturing records, protocols and reports (BMR, BPR, Test Methods, Stability Reports, etc.)

As the RA Officer you will also prepare, review and publish, in eCTD, New MA Applications (MAAs) for UK and EU territories as part of National, Decentralised or Mutual Recognition procedures

For National, Decentralised or Mutual Recognition procedures; prepare, review, publish and submit;

  • Quality and Safety variations (Type 1A, Type 1B and Type II)
  • Artwork (Labelling) changes, in accordance with Article 61.3
  • Renewals
  • Batch Specific Variations/Release (BSV/R), where applicable

Updating product information (SmPC and Labelling) in line with current EU guidelines/requirements (e.g. excipient warnings, QRD etc.) will also be a key part of your role

The Fit

You will need to hold a scientific degree

You will also need to demonstrate the ability to work to tight deadlines and in a time-pressured environment

You will also need to be able to travel Europe wide as required

If you have worked in the pharmaceutical industry this would be beneficial but isn't essential, please highlight the regulatory bodies and dosage forms you have worked with in your CV

To Apply

If you're ready to apply, fantastic! Click "apply" and if your CV is shortlisted I will call for an initial chat/screening in confidence within the next week.

Interviews will take place on an ad-hoc basis but if you're interested please don't hesitate as we are short listing as we speak!