EU REGULATORY AFFAIRS MANAGER - BIOSIMILARS LIVE
Career Category Regulatory Job Description 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.
What you will do
- Plan and manage EU/EEA regulatory submissions, including MAAs, responses to Health Authorities, CTAs/CTIS activities and post-approval lifecycle submissions.
- Partner with global and regional cross-functional teams, including CMC, Clinical, Safety, Quality, Legal and Commercial.
- Lead and support Health Authority interactions, including preparation of briefing materials, regulatory responses and follow-up actions.
- Support product information and labelling activities, including SmPC, Package Leaflet, artwork and regional label negotiations.
- Ensure regulatory compliance and maintenance of filings throughout development and the product lifecycle.
- Monitor evolving EU biosimilar legislation, guidance, regulatory policy and competitor intelligence, assessing potential impact on regulatory strategies.
- Contribute to regulatory processes, SOPs, templates and continuous improvement initiatives.
Be part of our team
We are currently looking for a Regulatory Affairs Manager based in either Portugal or the United Kingdom. You would be joining the European Regulatory Team, part of the Global Regulatory Affairs function in Europe. You would be working with colleagues who are responsible for leading the European regulatory strategies and submissions for development and marketed products from clinical trials to marketing authorisation, and throughout the products lifecycle.
WIN
What we expect of you We are all different, yet we all use our unique contributions to serve patients.
- Degree educated.
- Knowledge of drug development for Biosimilars within a regional regulatory environment including direct experience with EU biosimilar submissions and post-approval maintenance.
- Proven experience working with policies, procedures and SOP's.
- Awareness of the registration procedures in region for clinical trials, MA, post approval changes, extensions and renewals.
- Experience with EU Centralised Procedure and understanding of EU regulatory incentives.
- Strong communication skills - both oral and written.
- Ability to anticipate and prevent potential issues.
- Ability to resolve conflicts and develop a course of action leading to a beneficial outcome.
- Experience in a global or matrixed organization with collaboration across multiple regions.
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.
- Growth 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
Flexibility to work from home with few days per month working from our Cambridge, Uxbridge or Lisbon office. The expected gross pay range for this role in Portugal is EUR 48,957.00 to EUR 66,237.00. Actual pay will vary based on several factors including, but not limited to, relevant skills, experience, and qualifications. For candidates based in the UK, compensation will be aligned with the local market and role requirements, with further details discussed during the recruitment process.
Equal Opportunity Statement
Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status. We will ensure that individuals with disabilities are provided a reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request an accommodation.
Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology. Amgen focuses on areas of high unmet medical need and leverages its biologics manufacturing expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and has developing a pipeline of medicines with breakaway potential. For more information, visit www.amgen.com and follow us on www.twitter.com/amgen
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