Regulatory Affairs Sr Manager

Amgen Inc. (IR); Deerfield (IL); On-site; USD 167,000 - 204,000; Full time

Benefits offered by this job

Stock options

Retirement plan

Medical insurance

Life and disability insurance

Annual bonus

Job summary

Amgen Inc. seeks a Senior Regulatory Affairs Manager to formulate and present CMC regulatory strategies, coordinating regulatory submissions across investigational and marketed products.

You will align with R&D, Technical Operations, and Commercial teams to ensure compliant, timely deliverables and robust regulatory support. The role requires a Master’s degree in Regulatory Science or related field and 6 years of experience, including interactions with regulatory agencies and briefing documents.

Qualifications

• Master’s degree in Regulatory Science or related field with 6+ years in regulatory roles.
• Experience leading interactions with regulatory agencies and preparing briefing documents.
• Knowledge of international regulatory standards and drug development processes.

Responsibilities

• Formulate and present CMC regulatory strategies across investigational and marketed products.
• Coordinate and collaborate on CMC components of regulatory submissions and health authority meetings.
• Provide regulatory guidance to multidisciplinary project teams and maintain current knowledge of regulatory environment.

Skills

Regulatory strategy

CMC regulatory

Regulatory submissions

Health authority liaison

Education

Master's degree in Regulatory Science or related field

Tools

Veeva Vault

Job description

Career Category Regulatory Job Description Join Amgen’s Mission of Serving Patients At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission— to serve patients living with serious illnesses—drives all that we do. Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

Regulatory Affairs Sr Mgr Duties:

Formulate and present CMC regulatory strategies, ensuring alignment with corporate objectives, in conjunction with Technical Operations, R&D, Commercial and other internal stakeholders, as needed, across investigational and marketed products; Develop risk register for all major regulatory submissions outlining potential regulatory risks and proposals for mitigation strategies; Coordinate and collaborate on the preparation of CMC components of regulatory submissions; Provide guidance for and contribute actively to the development of CMC related documents for regulatory submissions, Health Authority Meetings Requests, and Briefing Books, ensuring that they meet current regulatory standards including guidance and expectations are high quality consistent, complete and approvable on the first review cycle; Develop strategies for and collaborate on preparation of responses to CMC-related topics with health authorities; Review manufacturing/testing change controls and provide regulatory impact assessments; Responsible for representing and supporting CMC regulatory on multidisciplinary project teams and providing CMC regulatory guidance; Ensure compliance with Health Authority expectations and regulatory guidance; and Maintain a knowledge base of current and emerging CMC regulatory environments, guidelines and best practices, and interpret and communicate relevant issues to colleagues. May telecommute.

Requirements:

Master’s degree (or foreign equivalent) in Regulatory Science, Environmental, Safety and Health management or a related field & 6 years of experience in the job offered or in an Associate or regulatory- related occupation. Experience also requires 6 years in the following: Leading interactions with Regulatory Agencies including the preparation of briefing documents and the coordination of meeting logistics; Organizing, preparing, or reviewing Chemistry, Manufacturing and Controls (CMC) content for clinical trial applications or marketing applications for submissions to health authorities; Compiling Chemistry, Manufacturing and Controls quality data utilizing Veeva Vault quality and regulatory information management system; Development and management of project timelines and deliverables; Knowledge of International regulatory standards concerning drug development including Good Laboratory Practices, Good Clinical Practices, or Good Manufacturing Practices; Knowledge of the Food and Drug Administration organization, roles, and responsibilities concerning drug development; and Analyze, summarize, and interpret scientific data with understanding of the applicable limitations of the data.

Compensation and Benefits:

The annual salary for this position in the U.S. is $185,619.00 per year. Also this position offers stock, retirement, medical, life and disability insurance and eligibility for an annual bonus or for sales roles, other incentive compensation. For more details visit https://careers.amgen.com/life-at-amgen/benefits/

Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.

What you can expect of us

As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well‑being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way. The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications. In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include:

• A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
• A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
• Stock-based long‑term incentives
• Award‑winning time‑off plans
• Flexible work models, including remote and hybrid work arrangements, where possible

In any materials you submit, you may redact or remove age‑identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.

Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law. We will ensure that individuals with disabilities are provided 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 accommodation.

Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology. Amgen focuses on areas of high unmet medical need and leverages its biologics manufacturing expertise to strive for solutions that improve health outcomes and dramatically improve people’s lives.

A biotechnology pioneer since 1980, Amgen has grown to be one of the world’s leading independent biotechnology companies, has reached millions of patients across the world and is developing a pipeline of medicines with breakaway potential.

For more information, visit www.amgen.com and follow us on www.twitter.com/amgen