Reference: 06942 Job Type: Permanent Date Posted: 16 October 2017
Job Type: Permanent
Date Posted: 16 October 2017
Labelling Operations and Compliance Manager
A genuinely exciting opportunity to work within an innovative, leading biotechnology company who are continually carrying out ongoing research programmes and truly value their patient’s needs.
You will take ownership of key labelling projects including a systems implementation and implementing new EU regulations, this is a high profile role enabling you to build your reputation within a global pharmaceutical company.
They are consistently ranked as a Top Employer by Science Magazine and are looking for a driven, dynamic Labelling Operations and Compliance professional to join their international Regulatory team.
This role will focus heavily on labelling, advertising and promotions; enhancing and developing new processes and implementing the new tracking software.
- Responsible for implementing process enhancements; including SOP and WI development.
- Oversight of compliance for global labelling; inspection readiness, tracking, maintenance of records.
- EU labelling; ensuring all communications and promotional material are compliant, managing EU linguistic process, EU readability, packaging and labelling review.
- Working cross functionally to assist with regional product labelling, core data sheets and tracking all relevant documents.
- Bachelor’s degree (ideally: life science) candidates are preferable.
- Relevant experience in Regulatory Affairs – specifically labelling.
- Excellent computer skills; sound working knowledge of MS Office, and any other relevant systems.
- Strong communication skills – both written and spoken with the ability to present key data to global management.
Park Street People Ltd does not discriminate on the grounds of age, race, gender, disability, creed or sexual orientation and complies with all relevant UK legislation. We are acting as an Employment Agency in relation to this role.
Labelling / EU readability / manual labelling / regulatory operations / regulatory affairs / global compliance / medical affairs / global packing / advertising and promotions
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*Terms and conditions apply
- PV Project management
- Fantastic step up in your PV career
- Leading niche CRO
£30,000 to £35,000 + Benefits
- Start-up company
- Healthcare industry
- Fantastic opportunity
- Providing strategic input to the future direction of the business
- Having oversight of satellite offices
- Risk Management plans / Safety Review meetings / MedDRA Coding