Regulatory Affairs Manager

What you will do

• Acquire and maintain the required licenses to support clinical trials for investigational medicinal products and for commercially approved products.
• Support one or more products from a regional regulatory perspective.
• Plan and manage regulatory submissions (clinical trial and marketing applications) for products within Amgen's portfolio, ensuring compliance with global filing plans and local regulatory requirements.
• Implement product related regulatory strategies, regulatory affairs processes, and activity planning in accordance with national legislation and regulatory requirements.
• Provide content guidance for regional regulatory documents and meetings in alignment with global strategy.
• Offer regulatory guidance on regional mechanisms to optimize product development (e.g., expediting first in human studies, Orphan Drug, Fast Track, compassionate use, and paediatric plans).
• Support regional label negotiation activities.
• Participate in the development and execution of regional regulatory product strategies.
• Develop predictions for expectations and risks associated with regulatory agency outcomes.
• Perform regulatory research to obtain relevant histories, precedents, and other information for regional product advancement.
• Evaluate and communicate the impact of relevant regional regulations, guidances, the current regulatory environment, and competitor labelling.

You will be joining the European Oncology Regulatory team, part of the Global Regulatory Affairs function in Europe. You will work with colleagues who lead the European regulatory strategies and submissions for development and marketed products from first in human clinical trials through marketing authorisation and throughout the product life cycle.

What we expect of you

• Scientific degree and demonstrated experience in a similar regulatory role.
• Knowledge of regulatory principles.
• Experience working with policies, procedures, and SOPs.
• Knowledge of legislation and regulations relating to medicinal products.
• Awareness of registration procedures in the region for clinical trials, marketing authorisation, post approval changes, extensions, and renewals.
• Knowledge of drug development.
• Experience in the regional regulatory environment.
• Strong oral and written communication skills.
• Ability to understand and communicate scientific/clinical information.
• Ability to anticipate and prevent potential issues.
• Ability to resolve conflicts and develop a course of action leading to a beneficial outcome.

What you can expect of us

• Growth opportunities to learn, move up, and progress across our global organization.
• A diverse and inclusive community where teammates are empowered to bring ideas to the table and act.
• A generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits.

Amgen is an Equal Opportunity employer and will consider you without regard to your race, colour, 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.