Regulatory Affairs Manager CMC

The Regulatory Affairs Manager CMC at Amgen is tasked with providing regulatory guidance and managing the strategy for product submissions. This includes developing global regulatory strategies, preparing CMC dossier content for new products and amendments, and aligning regulatory approaches with both internal teams and outside regulatory authorities. You'll also assess regulatory risks and monitor compliance with Amgen's internal processes and evolving regulatory frameworks.

To join Amgen as a Regulatory Affairs Manager CMC, candidates need a Doctorate degree, a Master’s with 3 years of experience, a Bachelor’s with 5 years, an Associate’s with 10 years, or a High school diploma with 12 years of directly related experience. Preferred qualifications include experience in CMC regulatory affairs, manufacturing, quality control, or clinical testing.

Amgen is committed to the professional and personal development of its employees, including those in regulatory roles. The company offers a comprehensive benefits package that includes retirement plans, medical coverage, and career development opportunities. Additionally, employees benefit from a flexible work model, allowing for balance in both personal and professional life.

Success as a Regulatory Affairs Manager CMC at Amgen requires strong analytical skills to assess regulatory risks, excellent communication abilities for liaising with various teams, and a depth of knowledge in regulatory compliance. The ability to adapt to changing regulatory environments while leading strategic initiatives is also crucial.

The expected salary range for the Regulatory Affairs Manager CMC role at Amgen in the U.S. is between $112,345 and $143,224 annually. Factors including relevant experience, skills, and qualifications can influence the actual salary offered.

When answering this question, focus on specific submissions you’ve managed, emphasizing your strategic approach to compliance and communication with regulatory bodies. Highlight any successful submissions and lessons learned from challenging cases.

Demonstrate your commitment to continuous learning by mentioning resources you follow, such as industry publications or professional networks. Discuss how you integrate new information into your work processes.

Use the STAR method (Situation, Task, Action, Result) to outline a specific instance where you identified a risk and successfully implemented a solution. This shows your proactive nature and problem-solving skills.

Discuss how you facilitate collaboration among different departments such as R&D, manufacturing, and marketing. Highlight specific examples where your input led to improved regulatory outcomes.

Explain your organizational strategies, such as using project management tools or prioritizing tasks based on regulatory deadlines. Focus on your ability to maintain quality while meeting demanding timelines.

Illustrate your approach to building relationships with health authorities. Discuss how transparency, responsiveness, and preparation of thorough documentation contribute to effective communication.

Provide an overview of your experience in preparing regulatory dossiers, emphasizing the components you focus on for completeness and compliance. Mention any specific tools or formats you find effective.

Share your insights on current regulatory challenges, such as evolving legislation, increasing complexity of products, or the need for faster approval processes. Discuss your perspective on how to address these challenges.

Describe your conflict-resolution techniques, such as fostering open communication or seeking consensus through data-driven discussions. Highlight your goal of maintaining a collaborative team environment.

Convey your enthusiasm for Amgen’s mission and values. Discuss how your skills align with their goals of patient care and innovation and how you see yourself contributing to their long-term vision.