Regulatory Affaris Manager

Amgen; London; On-site; GBP 50,000 - 100,000; Full time

Job summary

Amgen, a leading biotechnology company, is seeking a Regulatory Affairs Manager to ensure compliance with regulatory standards for clinical trials and market approval. The role involves collaboration with stakeholders to strategize submissions and navigate regulatory environments effectively, ensuring timely product development and approvals.

Benefits

Opportunities for learning and development

An inclusive community encouraging innovation

Comprehensive Total Rewards including healthcare benefits

Flexible work arrangements

Qualifications

• Experience in a similar regulatory role is essential.
• Knowledge of medicinal product policies and legislation.
• Understanding of drug development processes and regulatory environments.

Responsibilities

• Plan and manage regulatory submissions for clinical trials and marketing applications.
• Provide guidance on regional regulatory documents and strategies.
• Support label negotiations and monitor evolving regulatory policies.

Skills

Communication

Proactive issue resolution

Conflict management

Education

Scientific degree

Job description

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.