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Regulatory Affairs - Labelling

Regulatory Affairs - Labelling

  • Location

    Hitchin

  • Sector:

    Regulatory Affairs

  • Job type:

    Contract

  • Salary:

    £50 - 60 per hour

  • Contact:

    Joe Lane

  • Contact email:

    Joe.Lane@catalystcareers.com

  • Contact phone:

    02035899282

  • Job ref:

    LM46393

  • Published:

    10 months ago

  • Expiry date:

    2019-09-25

  • Consultant:

    #

Vacancy Details

I am recruiting a RA Labelling Lead for a global generics company based in Hertfordshire.

Title: RA Labelling Lead

Rate: up to £60 p/h

Location: Hertfordshire

Responsibilities:

  • Authoring of the SmPC, confirming compliance with mandated safety triggers, Brand Leader, CMC and relevant Labelling requirements.
  • Authoring of the Package Leaflet (PL) and Labelling, ensuring consistency with the proposed, or approved, SmPC, relevant safety triggers and Labelling requirements.
  • Review of proposed, or approved, PI texts for compliance with relevant mandated safety triggers, Brand Leader (or other Legal Basis Reference Product) and CMC data.
  • Working with Global Product Safety and Risk Management - Safety Surveillance Team contact to ensure that the content of PI texts authored is verified and agreed with the Safety Surveillance Team. Where agreement cannot be reached, escalation of the issue to Labelling Committee for endorsement of recommendations.

 

Looking but this isn't the right position for you?

If you are interested in a new opportunity but your experience doesn't fit this role, please email your CV to joe.lane@catalystcareers.com or call 0203 589 9282 for a confidential discussion about potential opportunities.

NOT OF INTEREST TO YOU BUT KNOW SOMEONE IT WOULD BE?

Catalyst Life Sciences offer a generous referral scheme reward, whereby anyone who refers us to a successfully placed candidate is entitled to up to £250 worth of vouchers.

 

Catalyst Life Sciences

Catalyst Life Sciences are a global recruitment company operating in the Life Sciences space, with specialist consultants working within the technical and regulatory areas. This includes the following markets;

  • Pharmacovigilance/Drug Safety
  • Regulatory Affairs
  • Quality Assurance
  • Quality Control
  • Medical Information
  • Medical Writers
  • Medical Affairs
  • Compliance
  • Audit
  • Validation
  • Production
  • Manufacturing
  • Clinical Trials
  • Clinical Research
  • Project Management
  • Finance

My Linked In Profile

https://www.linkedin.com/in/joe-lane/

I personally specialise in recruiting QA and validation professionals for roles globally so please do get in touch should you be considering new roles, or looking to fill ones at your current company!