Regulatory Labelling Mgr.
Job ID
10-685
Date Posted
Jun 1, 2023
Site Type
Remote, England, Cambridge
Description
HOW MIGHT YOU DEFY IMAGINATION?
If you feel like you’re part of something bigger, it’s because you are. At Amgen our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies. We are global collaborators who achieve together—researching, manufacturing and delivering ever-better products that reach over 10 million patients worldwide. It’s time for a career you can be proud of. Join us.
REGULATORY LABELLING MANAGER – REMOTE
LIVE
WHAT YOU WILL DO
As an experienced Regulatory Labelling Manager, you will lead cross functional labelling project teams to ensure excellent execution for product labels in 49 countries in Europe including creation of artwork components to enable timely launch of products.
KEY RESPONSIBILITIES:
Apply expert labelling knowledge, industry experience and business needs to provide strategic input to stakeholders (Reg Affairs, Regional Ops, Artwork, Commercial) for the creation and execution of all labelling packaging components and launch plans e.g. health authority requirements, colour, layout, pack sizes, languages, branding.
Develop EU package component labels according to regulations and company guidelines
Develop Patient leaflet content using knowledge gained from previous interactions with health authority and patients and execute it through regulatory approval to ensure safe and effective use of Amgen products
Accountable for successful Readability Testing: establish and execute process to successful results, (Revise EU label, patient leaflet, packaging components, instructions for use (collectively referred to as PI), prepare protocol and share with vendor, request patient leaflet mock-up, attend pilot stage testing and amend protocol/leaflet as necessary for main stage. Review and finalise readability testing report and ensure submission ready.
Accountable leading QRD compliance review of PI at all phases of health authority review and launch.
Labelling contact person for internal and external audits and inspections
Apply continuous improvement practices and processes by anticipating problem areas, looking at current processes and developing solutions; escalate issues appropriately..
Project manage timeline waivers and approve in labelling management tool. Triage and review deviation requests for appropriateness and completeness.
BE PART OF OUR TEAM
Labelling Process Management in Europe (LPM-EU) partner with 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 headed by the Director of Labelling Process Management, who are committed to providing timely, high quality and compliant product information.
Requirements
WIN
WHAT WE EXPECT OF YOU
Degree educated preferably, scientific specialism
Previous labelling experience within pharmaceutical industry within Europe
Extensive knowledge of EU labelling regulations and requirements, industry trends and business principles
Leadership skills, managing individual and complex group projects
Excellent oral and written communication skills
Excellent interpersonal skills with ability to develop relationships and work well with others in demanding situations
Influencing and negotiation skills
Excellent organizational and project management skills
Ability to take initiative and drive results
Efficient problem solver with proactive approach
Active member of industry specific groups and committees
THRIVE
WHAT YOU CAN EXPECT OF US
As we work to develop treatments that take care of others, so we work to care for our teammates’ professional and personal growth and well-being.
Vast opportunities to learn and move up and across our global organization
Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits
LOCATION: Cambridge or Uxbridge with flexible home working
Compensation/Benefits
Starting at $112,513 per year
Company Profile
If you’re seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you’ll find it at Amgen.
Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney diseases, rheumatoid arthritis and other serious illnesses.
As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.
Site/ Locations
Remote, England, Cambridge