Regulatory Affairs Sr Manager

Amgen; Illinois; Hybrid; USD 167,000 - 204,000; Full time

Benefits offered by this job

Stock-based incentives

Retirement plan

Medical, life and disability insurance

Flexible work models (remote & hybrid)

Job summary

Amgen is seeking a Regulatory Affairs Senior Manager to lead CMC regulatory strategies across investigational and marketed products, coordinating with Technical Operations, R&D, Commercial and other stakeholders. The role involves developing risk registers and ensuring high-quality regulatory submissions for health authorities.

The candidate should have a Master’s degree in Regulatory Science or related field with at least 6 years of regulatory experience, plus strong liaison and

Qualifications

• Master’s degree (or foreign equivalent) in Regulatory Science, Environmental, Safety and Health management or related field, with 6 years’ regulatory experience.
• Experience leading interactions with Regulatory Agencies, including preparation of briefing documents and coordination of meetings.
• Experience compiling Chemistry, Manufacturing and Controls (CMC) content for regulatory submissions and maintaining regulatory information systems (e.g., Veeva Vault).

Responsibilities

• Formulate and present CMC regulatory strategies aligned with corporate objectives.
• Develop risk register for major regulatory submissions and mitigation plans.
• Coordinate CMC components of regulatory submissions and health authority meetings.
• Provide guidance on CMC documents and ensure high-quality submissions on first review cycle.
• Review manufacturing/testing change controls and perform regulatory impact assessments.
• Represent CMC regulatory on multidisciplinary project teams and maintain regulatory knowledge.

Skills

Regulatory strategy development

CMC regulatory expertise

Regulatory submissions coordination

Cross-functional collaboration

Health Authority liaison

Education

Master’s degree in Regulatory Science (or related field)

Tools

Veeva Vault

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 limits of the data.

Job type: Full Time position. 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 visithttps://careers.amgen.com/life-at-amgen/benefits/

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

careers.amgen.com

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 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.

As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.

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.