German-speaking Senior Regulatory Compliance Officer — Biotech

🏢 ABOUT THE COMPANY

Amgen, a Fortune 100 biotechnology company, was founded in 1980 and is headquartered in Thousand Oaks, California. Our mission is to serve patients by transforming lives through innovative medicines. As one of the largest biotechnology companies in the world, we're proud of our diverse and inclusive culture, commitment to excellence, and dedication to making a meaningful impact on global health. With a strong track record of innovation and a talented team of over 25,000 employees worldwide, Amgen is a great place to work for those passionate about making a difference in the lives of patients.

🎯 ROLE OVERVIEW

As a Senior Regulatory Compliance Officer based in remote Germany, you will play a critical role in ensuring Amgen's compliance with regulatory requirements and industry standards related to biotechnology products. You will report to the Regional Head of Compliance and work closely with cross-functional teams to address compliance risks and implement effective solutions. Your expertise will directly impact the success of our business, driving growth and innovation while maintaining our commitment to regulatory excellence.

📋 KEY RESPONSIBILITIES

• Serve as a subject matter expert on regulatory requirements and industry standards related to biotechnology products, advising business leaders and internal stakeholders on compliance matters.

• Develop and implement effective compliance strategies to mitigate risks and ensure regulatory compliance, including policy development, training, and monitoring.

• Collaborate with cross-functional teams to address compliance risks, provide guidance on regulatory inquiries, and ensure accurate reporting and documentation.

• Conduct regular audits and assessments to identify compliance gaps and implement corrective actions.

• Develop and maintain relationships with regulatory agencies, industry associations, and external partners to stay updated on regulatory changes and industry developments.

• Mentor junior compliance professionals and provide guidance on regulatory compliance matters.

• Stay up-to-date on relevant laws, regulations, and industry standards, making recommendations for updates to policies and procedures.

• Develop and deliver training programs on compliance topics, ensuring regulatory excellence across the organization.

• Collaborate with the compliance team to develop and implement compliance metrics and monitoring plans.

• Maintain accurate and complete records of compliance activities, including reporting, audits, and metrics.

✅ REQUIRED QUALIFICATIONS

• Bachelor's degree in a related field (e.g., law, regulatory affairs, life sciences) and a minimum of 8 years of experience in regulatory compliance, preferably in the biotechnology or pharmaceutical industry.

• Advanced degree (e.g., Master's, JD) and/or certifications (e.g., CCO, CFC) are a plus.

• Strong knowledge of relevant laws, regulations, and industry standards, including EU regulations (e.g., GDPR, MDR).

• Experience with compliance software and tools, including electronic systems, is highly desirable.

• Excellent communication, problem-solving, and analytic skills, with ability to work in a fast-paced environment and meet deadlines.

• Fluency in German and English, with ability to communicate effectively with international teams.

⭐ PREFERRED QUALIFICATIONS

• Experience working with regulatory agencies and industry associations, such as the European Medicines Agency (EMA).

• Knowledge of quality management systems, including ISO 13485.

• Familiarity with cloud-based compliance systems and tools.

• Advanced analytical and problem-solving skills, with ability to identify and address complex compliance issues.

• Experience mentoring and leading junior compliance professionals.

💰 WHAT WE OFFER

Amgen offers a highly competitive salary range of EUR 50,000 to EUR 80,000 per year, depending on experience. In addition to your salary, we provide a comprehensive benefits package, including health insurance, retirement plan, and generous vacation time. You will also have access to our Learning and Development budget, designed to support your growth and professional development. Our team culture values collaboration, diversity, and innovation, and we offer a hybrid work policy, with opportunities to work remotely and in our office. As a Senior Regulatory Compliance Officer, you will have a clear career path for growth and development, with opportunities to take on new challenges and responsibilities.

👥 ABOUT THE TEAM

You will join a dynamic and experienced team of compliance professionals who are passionate about regulatory excellence and committed to driving business growth. Our team is collaborative, innovative, and results-driven, with a strong focus on customer satisfaction and regulatory compliance. We are proud of our recent wins and projects, including the development of new policies and procedures, and the successful implementation of compliance software and tools.

📨 HOW TO APPLY

If you are a highly motivated and experienced regulatory compliance professional looking to take on new challenges and responsibilities, please submit your application, including your CV and a cover letter outlining your relevant experience and qualifications. We look forward to hearing from you and discussing how you can contribute to our team's success.

📋 Job Details

Job Type	🌐 Remote
Location	Munich, DE
Address	Am Gelnhaar 1, 81673
Salary	EUR 50,000 – 80,000 / year
Industry	General
Company	Amgen
Valid Until	2026-09-14

📨 How to Apply

Submit your updated CV and a brief cover letter to Amgen. Applications are reviewed on a rolling basis. Only shortlisted candidates will be contacted within 2 weeks of applying.