Amgen Senior Regulatory Labelling Associate in Cambridge, United Kingdom

Senior Regulatory Labelling Associate

Amgen Regulatory Labelling team are looking for an enthusiastic team player who is detail-oriented and has excellent verbal and written communication skills. Your key role will be to support the EU Labelling managers in executing Labelling tasks.

If you are looking for your next career step within Regulatory Labelling field and want to be part of our mission - To serve patients - which drives all that we do, apply or get in touch. Take a look at our career pages to find out more about Amgen UK https://careers.amgen.com/where-we-are/en-gb/

Our Regulatory Labelling Team:

Labelling Process Management in Europe (LPM-EU) support the European Regional Regulatory Leads, Local Regulatory Representatives, Operations and Artwork in implementing product labelling into the European market. We are a small, friendly team committed to providing timely, high quality and compliant product information.

Sr Regulatory Labelling Associate role overview:

The Sr Regulatory Labelling Associate will report to the European Labelling Senior Manager. In this role, you will support all commercial products from a regional (European Union and extended Europe) labelling perspective.

As a Senior Regulatory Labelling Associate, you will provide product support to corporate Global Labelling and Regulatory staff (both regional and local) in implementing and maintaining processes for drug product information and product component labelling. The role is varied and requires high attention to detail and the ability to work on multiple tasks in parallel.

Responsibilities:

EU centralised procedure submissions:

  • Initiate linguistic review with vendor

  • At CHMP opinion, provide linguistic review timetable to vendor, EURL and LRRs

  • Monitor Linguistic Review trackers

  • End of member state review deadline follow up with EMA for any missing comments

  • Finalise translations and submit to agency

EU artwork projects:

  • Finalise translations for artwork, initiate approval dating, PV and contact details in leaflet, source text provision in LEXA - Amgen's end to end labelling tracking tool.

  • Approve English master artwork (ensure alignment between approved source and text mapping) for cartons, labels, leaflets etc.

LEXA tasks:

  • Triage requests for label change

  • Complete LEXA-IMR linkage

  • Initiate and complete detailed artwork project tasks

  • Link source text to Artwork Projects

  • Complete 'Approve Internally' action for Submission Packs

  • Initiate Artwork Projects in LEXA for launches as requested by ROLs

  • Complete post health authority approval tasks, initiate global labelling notifications (GLN) at procedure approval, distribute notification and complete 'GLN Sent Date'

  • Complete public domain tasks

Translation management:

  • Initiate translations using the translation management tool

  • Inform LRRs of translation timelines

  • Interactions with vendors and Local Regulatory Representatives (LRR):

Other responsibilities will include:

  • Support local regulatory by providing guidance in maintaining data in LEXA and documents in the document management system (EPIC), including clarification of processes

  • As requested, support the development and maintenance of business process documentation and guidance; SOPs, manuals, forms, and eManual

  • Support initiatives which involve labelling

Qualifications and required experience:

  • Previous experience within pharmaceutical industry within, Labelling, Regulatory, Quality Management / Quality Engineering is required

  • Proven experience using document management tools

Proven experience and skills needed :

  • Strong oral and written communication skills

  • Strong interpersonal, collaborative, problem solving and conflict resolution skills

  • Ability to work well with others in demanding situations with a positive attitude

  • Ability to work in a fast-paced environment while retaining a high attention to detail

  • Excellent organizational and project management skills

  • Strong computer skills, including word processing, database document repository and project management software

Location: Cambridge or Uxbridge

Remuneration: Competitive salary & comprehensive benefits package including bonus scheme

About our company:

Amgen is one of the world's largest independent biotechnology companies, with global revenue of $23 billion and nearly 20,000 employees globally. For more than 35 years, Amgen has pioneered biotechnology breakthroughs, to bring state-of-the-art medicines from laboratory to the patient. Amgen has not only discovered and developed innovative human therapeutics, but has invested in cutting edge manufacturing capability and support services to deliver these exciting therapies to medical teams around the world.