At a Glance
- Tasks: Lead regulatory strategies across Europe, Latin America, Middle East, Africa & Canada to enhance patient access.
- Company: Join Amgen, a pioneering biotech company dedicated to serving patients with serious illnesses.
- Benefits: Enjoy competitive pay, comprehensive benefits, flexible work models, and career development opportunities.
- Other info: Be part of an inclusive culture that values diversity and innovation.
- Why this job: Make a real impact on global health while advancing your career in a collaborative environment.
- Qualifications: Doctorate or Master's degree with extensive regulatory experience and leadership skills.
The predicted salary is between 100000 - 150000 € per year.
Join Amgen's mission to serve patients living with serious illnesses. Since 1980, we've helped pioneer the world of biotech in our fight against the world's toughest diseases. With a 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.
In this vital role as Vice President, Regulatory Affairs ELMAC (Europe, Latin America, Middle East, Africa & Canada), you will set the strategic direction for Regulatory Affairs across ELMAC, ensuring the organization delivers compliant, innovative, and forward‐looking regulatory strategies that accelerate patient access and support enterprise growth. You will operate as a key member of the global regulatory leadership team, shaping both regional execution and the future of the regulatory function.
What you will do:
- Set and lead the regional regulatory strategy.
- Build and lead a high‐performing organization.
- Serve as a strategic advisor to senior leadership.
- Partner closely with country leadership to ensure regulatory strategies enable local business objectives.
- Champion new ways of working across Regulatory Affairs.
- Ensure consistent, high‐quality regulatory submissions and labeling practices.
- Represent the organization with global and regional health authorities.
- Anticipate and help lead the evolution of Regulatory Affairs.
What we expect of you:
The candidate we seek is an experienced leader with the following qualifications:
- Doctorate degree & 8 years of directly related experience OR Master's degree & 10 years of directly related experience OR Bachelor's degree & 12 years of directly related experience AND 8 years of direct managerial experience.
- Advanced degrees (e.g., Ph.D. or PharmD) preferred.
- A minimum of eight years of industry experience, including direct leadership of highly skilled teams.
- Extensive knowledge of regulatory requirements and strategies.
- Proven ability to lead, manage, and inspire teams within a complex matrix structure.
- Experience navigating regional and local regulatory landscapes.
- Strong ability to engage with regulatory authorities and key external stakeholders.
- Strong understanding of the pharmaceutical industry and compliance considerations.
- Experience in budgeting, resource allocation, and operational efficiency.
- Skilled in articulating complex regulatory and scientific concepts.
What you can expect of us:
Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans, work/life balance, and career development opportunities, including:
- Comprehensive employee benefits package.
- A discretionary annual bonus program.
- Stock‐based long‐term incentives.
- Award‐winning time‐off plans.
- Flexible work models where possible.
Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values. 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 any protected status.
Vice President, Regulatory Affairs – ELMAC in Uxbridge employer: Amgen SA
Amgen is an exceptional employer that prioritises the well-being and professional growth of its employees while driving innovation in biotechnology. With a collaborative and inclusive culture, employees benefit from comprehensive health plans, generous retirement contributions, and flexible work models, all aimed at fostering a fulfilling work-life balance. Joining Amgen means being part of a mission-driven team dedicated to transforming patient lives and advancing science, making it a truly rewarding place to build your career.
StudySmarter Expert Advice🤫
We think this is how you could land Vice President, Regulatory Affairs – ELMAC in Uxbridge
✨Tip Number 1
Network like a pro! Reach out to your connections in the industry, attend relevant events, and engage with professionals on platforms like LinkedIn. We all know that sometimes it’s not just what you know, but who you know that can help you land that dream job.
✨Tip Number 2
Prepare for interviews by researching Amgen's mission and values. Understand their focus areas and think about how your experience aligns with their goals. We want to see you shine, so practice answering common interview questions and have your own questions ready to show your interest!
✨Tip Number 3
Follow up after interviews! A simple thank-you email can go a long way in keeping you top of mind. We appreciate candidates who show enthusiasm and professionalism, so don’t hesitate to express your gratitude for the opportunity.
✨Tip Number 4
Keep an eye on our website for new openings and updates. Applying directly through our site not only shows your interest but also ensures your application is seen by the right people. We’re always looking for passionate individuals to join our mission!
We think you need these skills to ace Vice President, Regulatory Affairs – ELMAC in Uxbridge
Some tips for your application 🫡
Tailor Your Application:Make sure to customise your CV and cover letter for the Vice President, Regulatory Affairs role. Highlight your relevant experience in regulatory strategies and leadership, showing how you align with Amgen's mission to serve patients.
Showcase Your Leadership Skills:In your application, emphasise your experience in leading high-performing teams and managing complex projects. We want to see how you've inspired others and driven results in a matrix organisation.
Be Clear and Concise:When writing your application, keep it straightforward and to the point. Use clear language to articulate your achievements and how they relate to the role, making it easy for us to see your fit for the position.
Apply Through Our Website:Don't forget to submit your application through our official website! This ensures that your application is processed correctly and gives you the best chance of being considered for the role.
How to prepare for a job interview at Amgen SA
✨Know Your Regulatory Landscape
Before the interview, dive deep into the regulatory requirements specific to the ELMAC region. Familiarise yourself with the latest trends and challenges in regulatory affairs, especially in oncology and rare diseases. This knowledge will not only impress your interviewers but also show that you're proactive and well-prepared.
✨Showcase Leadership Experience
As a Vice President, you'll need to demonstrate your ability to lead high-performing teams. Prepare examples of how you've successfully managed and inspired teams in complex environments. Highlight your strategic decision-making skills and how you've navigated challenges in previous roles.
✨Align with Amgen's Mission
Amgen is all about serving patients. Make sure you articulate how your personal values align with this mission. Share stories that reflect your commitment to improving patient outcomes and how you've contributed to similar goals in your past roles.
✨Prepare for Strategic Discussions
Expect to engage in discussions about regulatory strategies and enterprise alignment. Brush up on your ability to connect regional insights with global priorities. Be ready to discuss how you would approach building relationships with health authorities and industry groups to enhance regulatory pathways.
