EU Regulatory Affairs Senior Manager - Oncology

OverviewCareer Category RegulatoryJob DescriptionHOW 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.SENIOR REGULATORY AFFAIRS MANAGERLIVEWhat you will doIn this vital role you will work to ensure that Amgen acquires and maintains all the required licenses in order to support clinical trials for investigational medicinal products as well as market commercially approved medicinal products.Representing the EU region, you will be responsible for advising the GRT on regional considerations in developing strategy, and ensuring the regional needs are well defined and implemented in collaboration with relevant regional stakeholders.

Develop and execute regional regulatory product strategies, including precedence, risk management and contingency planning

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)

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 teamYou would be joining the European Regulatory team, part of the Global Regulatory Affairs function in Europe. You would be 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.

What 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 development

What 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.

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 ..... full job details .....