Career Category: Regulatory
Job Description
Join our team at AMGEN Capability Center Portugal, the number 1 company in Best WorkplacesTM Portugal (category 201-500 employees) by the Great Place to Work Institute. We have over 300 talented professionals from more than 35 nationalities, working across diverse areas such as Cybersecurity, Data & Analytics, Digital, Technology and Innovation, Finance, General & Admin, Human Resources, Regulatory Affairs, and more. Located in Lisbon's city center, our AMGEN office fosters innovation, excellence, and inspiration. Join us at AMGEN and support our mission: To Serve Patients. Our work at AMGEN truly matters in people's lives.
REGULATORY AFFAIRS MANAGER
LIVE
WHAT YOU WILL DO
This critical role involves ensuring that Amgen acquires and maintains all necessary approvals to support clinical trials and market approved medicinal products. You will support one or more products from a regional regulatory perspective, ensuring compliance with all regulatory requirements and timelines.
The responsibilities include:
* Defining and implementing regional needs in collaboration with relevant stakeholders.
* Planning and managing regulatory submissions for clinical trials and marketing applications, ensuring compliance with global and local requirements.
* Assisting in developing and executing regional regulatory strategies, including risk assessments and outcome forecasting.
* Providing guidance on regional regulatory documents and meetings aligned with global strategies.
* Offering regulatory guidance on mechanisms to expedite product development, such as FIH studies, Orphan Drug, Fast Track, and compassionate use.
* Supporting label negotiations and monitoring evolving regulatory policies, legislation, and competitor labeling to assess their impact.
WHAT WE EXPECT OF YOU
We value diverse contributions to serve patients. Our ideal candidate will have:
* A scientific degree and experience in a similar regulatory role.
* Knowledge of policies, procedures, SOPs, and legislation related to medicinal products.
* Understanding of regional regulatory procedures for MAs, CTAs, and post-approval changes.
* Knowledge of drug development processes and the ability to navigate international regulatory environments.
* Strong communication skills, proactive issue resolution, and conflict management abilities.
WHAT YOU CAN EXPECT FROM US
* Opportunities for learning, development, and career progression globally.
* An inclusive community encouraging ideas, innovation, and risk-taking.
* Comprehensive Total Rewards including healthcare, financial, and career benefits.
* Flexible work arrangements.
APPLY NOW
Objects in your future are closer than they appear. Join us.
CAREERS.AMGEN.COM
EQUAL OPPORTUNITY STATEMENT
Amgen is an Equal Opportunity employer. We consider all applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran status, or disability. We provide reasonable accommodations for individuals with disabilities during the application and interview process. Please contact us to request accommodations.
#J-18808-Ljbffr