Regulatory Affaris Manager

Amgen; United States; Remote; USD 90,000 - 140,000; Full time

Job summary

Join Amgen as a Regulatory Affairs Manager, where you will play a critical role in ensuring compliance for our investigational medicinal products and approved products. In this role, you will manage regulatory submissions and collaborate with regional stakeholders to achieve regulatory goals. This is a unique opportunity to contribute to life-changing therapies in a diverse environment.

Benefits

Generous Amgen Total Rewards Plan

Flexible work arrangements

Opportunities to learn and develop

Qualifications

• At least 4 years of experience in a similar role.
• Familiar with policies, procedures, and regulations related to medicinal products.
• Awareness of regulatory procedures for market authorizations and clinical trials.

Responsibilities

• Manage regulatory submissions for clinical trials and marketing applications.
• Develop regulatory strategies and processes in compliance with regional requirements.
• Provide content guidance for regional regulatory documents.

Skills

Strong communication skills

Knowledge of drug development

Ability to resolve conflicts

Education

Scientific Degree

Job description

Career Category Regulatory Job Description

Join our team atAMGEN Capability Center Portugal, number 1 company in Best WorkplacesTMhttps://www.greatplacetowork.pt/ranking in Portugal (category 201-500 employees) by the Great Place to Work Institute. We have a team of over 300 talented people and more than 35 different nationalities, diverse areas of expertise and professional experience that are shaping the future of healthcare. This is your chance to explore a world of opportunities in different areas such as Cybersecurity, Data & Analytics, Digital, Technology and Innovation, Finance, General & Admin, Human Resources, Regulatory Affairs and many more. In Lisbon's city center, our AMGEN office fosters innovation, excellence, and inspiration. Come thrive with us at AMGEN, supporting our mission To Serve Patients. What we do at AMGEN matters in people’s lives.

REGULATORY AFFAIRS MANAGER

LIVE

WHAT YOU WILL DO

In this vital role you will ensure that Amgen acquires and maintains all the required approvals to support clinical trials for investigational medicinal products as well as to market approved medicinal products. You will support one or more products from a regional regulatory perspective and ensure timely regulatory compliance with above approvals.

The responsibilities of the role will include:

• Ensuring the regional needs are well defined and implemented in collaboration with relevant regional stakeholders.
• 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.
• Under supervision, assist in developing and executing regional regulatory strategies and processes in compliance with national requirements, including risk assessment and outcome forecasting under general supervision.
• Provide content guidance for regional regulatory documents and meetings in accordance with global strategy
• Provide regulatory guidance on regional regulatory mechanisms to optimize product development (e.g. expediting FIH studies, Orphan Drug, Fast Track, compassionate use and paediatric plans)
• Support regional label negotiation activities and regional product advancement by monitoring and researching evolving regulatory policies, legislation, and competitor labeling, and assessing their impact under supervision.

WIN

WHAT WE EXPECT OF YOU

We 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:

• Scientific Degree and at least 4 years experience in a similar role.
• Previous working experience with policies, procedures, and SOPs, and knowledge of legislation and regulations relating to medicinal products.
• Awareness of the regulatory procedures in region for MAs, CTAs, post approval changes and amendments, extensions, and renewals.
• Knowledge of drug development and sensitivity to achieve results across both regional country and international borders.
• Strong communication skills, ability to anticipate and prevent potential issues as well as to resolve conflicts and develop a course of action leading to a helpful outcome.

THRIVE

WHAT YOU CAN EXPECT OF US

• Vast opportunities to learn, develop, and move up and across our global organization.
• Diverse and inclusive community of belonging, where colleagues are empowered to bring ideas to the table, take risks, and act.
• Generous Amgen Total Rewards Plan comprising healthcare, finance, wealth, 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 and will consider you without regard to your race, color, 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 crucial job functions, and to receive other benefits and privileges of employment. Please contact us to request an accommodation.

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