Regulatory Affairs Manager at Amgen: A Detailed Job Description

Amgen harnesses the best of biology and technology to fight the world’s toughest diseases and make people’s lives easier, fuller, and longer. Amgen helped establish the biotechnology industry more than 40 years ago and remains on the cutting-edge of innovation, using technology and human genetic data to push beyond what’s known today. We discover, develop, manufacture, and deliver innovative medicines to help millions of patients.

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.

The Role: Regulatory Affairs Manager

Post: Regulatory Affairs Manager

In 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. You will support one or more products from a regional regulatory perspective.

Role Description

The International Regulatory Lead (IRL) Manager will provide regulatory leadership & expertise for International countries for one or more Amgen products. This role involves collaboration with various functions and local regulatory teams to:

• Optimize product development and regulatory approvals in International countries.
• Develop international regulatory strategy and provide regulatory support for in-country product registrations and life cycle management.

Responsibilities and Duties

As a Regulatory Affairs Manager at Amgen, your roles and responsibilities will include a variety of tasks related to regulatory strategy, submissions, and compliance. The following points elaborate on the expected duties:

• Advising global teams on regulatory implications and requirements relevant to the global clinical development, Marketing Applications plans, and objectives.
• Providing regulatory direction/expertise on the international regulatory mechanisms to optimize product development (e.g., expediting FIH studies, Orphan Drug, expedited regulatory designations, regulatory reliance mechanisms, compassionate use, and pediatric plans).
• Under general supervision, planning regulatory submissions (e.g., clinical trial, marketing authorization applications, and lifecycle management) for products within Amgen's portfolio.
• Under general supervision, contributing to the development of international regulatory strategy documents (regulatory product filing plan, strategies, risks associated with the potential Agency outcomes and contingency planning, estimate likelihood of success) and communicates to others, as appropriate.
• Providing and maintaining clinical trial and/or marketing application documentation (excluding Chemistry, Manufacturing & Controls documentation).
• Implementing product-related regulatory strategies, Regulatory Affairs processes, and activity planning in accordance with national legislation and regulatory requirements.
• Providing content guidance for regional regulatory documents and meetings in accordance with global strategy.
• Supporting regional label negotiation activities.
• Under general supervision, participating in the development and execution of regional regulatory product strategies.
• Under general supervision, developing predictions for expectations and risks associated with outcomes by regulatory agencies.

Key Activities

Your activities will span across strategy and execution, and regulatory research.

Strategy and Execution

• 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.
• 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).

Regulatory Research

• Maintain an awareness of new and developing legislation, regulatory policy and technical Regulatory guidance relating to Amgen products.
• Perform regulatory research to obtain relevant histories, precedence and other information relevant to regional product advancement.
• Under supervision evaluate and communicate impact of relevant regional regulations, guidances, current regulatory environment and competitor labelling.

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 demonstrated experience in a similar role.
• Regulatory principles + Working with policies, procedures and SOP’s + Knowledge of legislation and regulations relating to medicinal products + Awareness of the registration procedures in region for clinical trials, MA, post approval changes, extensions and renewals.
• Knowledge of drug development.
• Knowledge of and experience in regional regulatory environment.
• Strong communication skills - both oral and written.
• 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.

Skills and Qualifications

To excel in the role of a Regulatory Affairs Manager at Amgen, certain skills and qualifications are essential. These include:

• Educational Background: A scientific degree is a fundamental requirement, providing the necessary foundation for understanding complex scientific and clinical data.
• Regulatory Knowledge: Comprehensive knowledge of regulatory principles, policies, procedures, and SOPs is crucial. This includes a deep understanding of legislation and regulations related to medicinal products.
• Regional Awareness: Familiarity with registration procedures in the region for clinical trials, marketing authorizations (MA), post-approval changes, extensions, and renewals is necessary.
• Drug Development Expertise: A solid understanding of drug development processes is vital for navigating the regulatory landscape effectively.
• Communication Skills: Strong communication skills, both written and oral, are essential for conveying complex information to various stakeholders.
• Analytical Skills: The ability to understand and communicate scientific/clinical information accurately is critical for making informed decisions and providing sound regulatory guidance.
• Proactive Problem-Solving: The capacity to anticipate and prevent potential issues, along with the ability to resolve conflicts and develop beneficial courses of action, is highly valued.

Interview Preparation

It’s the best way to ensure your application gets seen.

• Network like a pro! Prepare for interviews by researching the company and its products. Understand their regulatory processes and be ready to discuss how your experience aligns with their needs.
• Practice makes perfect! Conduct mock interviews with friends or use online resources to refine your answers.
• Make sure your CV reflects the skills and experiences that align with the Regulatory Affairs Manager role.
• Your cover letter is your chance to shine! Use it to explain why you’re passionate about regulatory affairs and how your background makes you a perfect fit for Amgen.
• Since this role requires a scientific degree, be sure to emphasise your educational background and any specific knowledge related to drug development and regulatory environments.
• Make sure you brush up on the latest regulations and guidelines related to medicinal products. Familiarise yourself with the specific legislation that affects clinical trials and marketing authorisations in your region.
• Expect questions that ask how you would handle specific regulatory challenges or scenarios. Think about past experiences where you've navigated complex regulatory environments and be ready to discuss your thought process and outcomes.
• As a Regulatory Affairs Manager, strong communication is key. Be prepared to discuss how you've effectively communicated complex scientific information to various stakeholders.
• At the end of the interview, don’t shy away from asking questions. Inquire about the team dynamics, current projects, or how the company stays ahead of regulatory changes.

What You Can Expect From Us

As 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 benefits.

LOCATION: Flexibility to work from home with few days per month working from our Cambridge or Uxbridge office.

APPLY NOW for a career that defies imagination. In our quest to serve patients above all else, Amgen is the first to imagine, and the last to doubt.

At Amgen, we pride ourselves on being a leading biotechnology company that prioritises the well-being and growth of our employees. With a flexible work environment in Cambridge and Uxbridge, we offer generous benefits, a commitment to diversity and inclusion, and ample opportunities for professional development, making us an exceptional employer for those looking to make a meaningful impact in the healthcare sector.

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