European Regulatory Affairs Lead

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.

EUROPEAN REGULATORY AFFAIRS LEADLIVEWhat you will doIn this vital role, you will ensure Amgen obtains and maintains the regulatory licenses required to support clinical development and commercialization of medicinal products. You will represent the region in shaping regulatory strategy, providing regional expertise, and collaborating with stakeholders to ensure regional requirements are effectively incorporated into global plans.

Plan and manage regulatory submissions (e.g. clinical trial and marketing applications) for products within Amgen's portfolio in compliance with global filing plans and local regulatory requirements

Implement product related regulatory strategies, Regulatory Affairs processes and activity planning

Lead development of regional regulatory documents and meetings in accordance with GRT strategy

Provide regulatory direction on regional regulatory mechanisms to optimize product development (e.g. expediting FIH studies, Orphan Drug, Fast Track, compassionate use and paediatric plan)
Participate in the development and execution of regional regulatory product strategies, including precedence, risk management and contingency planning

Consistent with GRT strategy, advise on regulatory implications and requirements related to global clinical development plans and objectives

Lead Health Authority and Agency Interactions and document and communicate outcomes appropriately

Be part of our team

You would be joining the European General Medicine 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 first in human clinical trials to marketing authorisation, and throughout the products lifecycle.

This team is leading the regulatory activities for established products and also development assets in the Metabolic, Cardiology, Inflamation, Endocrine and Bone disease areas, as well as pre-approval filing activities for Biosimilars.

WINWhat we expect of youWe are all different, yet we all use our unique contributions to serve patients. What we seek in you as an experienced  professional, are these qualifications and skills:

Degree educated in a scientific discipline

Extensive experience in regional regulatory environment

Proven track record of developing and executing regional regulatory strategy

In-depth understanding of the drug life cycle and development process from a regulatory perspective

In-depth understanding of the registration procedures in region for MA, post approval changes, extensions and renewals.

Ability to lead teams and work collaboratively in a dynamic environment

Proactive approach to problem solving

Ability to understand and communicate scientific/clinical information

Ability to anticipate regulatory agency expectations

Strong awareness of the needs of internal and external stakeholders, and the role of Regulatory Affairs in driving successful drug developmentTHRIVEWhat you can expect of usAs 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:

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 68,000.00 to 92,000.00. Actual pay will vary based…