Full-Time
Regulatory Affairs Manager
Oncology, General Medicine
Updated on 9/10/2026
Amgen
10,001+ employees
Biotech company creating biologic medicines
Compensation Overview
€49k - €66.2k/yr
Remote in UK + 5 more
More locations: London, UK | Edinburgh, UK | Uxbridge, UK | Cambridge, UK | Manchester, UK
Hybrid
Work from home with a few days per month in the Cambridge, Uxbridge, or Lisbon office.
Bachelor's
 Biology & Biotech (1) |
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- A degree and previous experience in a similar role are required.
- Hands-on experience with regional registration procedures, including clinical trials, pre-marketing authorisation application regulatory procedures, scientific advice, orphan applications, Paediatric Investigation Plans, marketing authorisation, post-approval changes, extensions, and renewals is required.
- Experience developing regulatory strategies for products in clinical development and post-marketing phases is required.
- Knowledge of European Union legislation and regulations relating to medicinal products is required.
- Experience working with policies, procedures, and standard operating procedures is required.
- Strong oral and written communication skills are required.
- The ability to anticipate and prevent potential issues is required.
- The ability to resolve conflicts and develop a course of action leading to a beneficial outcome is required.
- Basic proficiency in using artificial intelligence tools to support day-to-day work is required.
- Ensure that the company acquires and maintains required European Union licenses to support clinical trials for investigational medicinal products and marketed medicinal products.
- Support one or more products from a European Union regulatory perspective.
- Depending on business needs and experience, serve as the European Union Regulatory Lead for one or more products.
- Plan and manage regulatory submissions, including clinical trial and marketing applications, in compliance with global filing plans and European Union regional regulatory requirements.
- Implement product-related regulatory strategies, Regulatory Affairs processes, and activity planning in accordance with European Union regional legislation and regulatory requirements.
- Provide content guidance for regional regulatory documents and meetings in accordance with the global strategy.
- Provide regulatory guidance on regional regulatory mechanisms to optimize product development, including expedited first-in-human studies, scientific advice, orphan drug mechanisms, marketing authorisation mechanisms, and paediatric plans.
- Support European Union label negotiation activities.
- Participate in the development and execution of regional regulatory product strategies.
- Develop predictions for expectations and risks associated with regulatory agency outcomes.
- Maintain awareness of new and developing legislation, regulatory policy, and technical regulatory guidance relating to company products.
- Perform regulatory research to obtain relevant histories, precedents, and other information relevant to regional product advancement.
- Evaluate and communicate the impact of relevant regional regulations, guidances, the current regulatory environment, and competitor labelling.
Amgen develops medicines that treat serious illnesses by using biologic therapies made from living cells. These therapies are designed to target specific disease processes, such as cancer, cardiovascular disease, and autoimmune conditions, and are produced through biotechnology methods that create proteins or antibodies. Amgen’s products are sold to patients and healthcare providers worldwide, with revenue funding ongoing research and development to discover new treatments. The company stands out by focusing on biologic medicines at a large scale and maintaining a steady pipeline of potential therapies across multiple disease areas, supported by global manufacturing and a commitment to bringing therapies to patients. Its goal is to improve patient outcomes by discovering and delivering new, effective treatments while reinvesting a significant portion of earnings into research and development.
Company Size
10,001+
Company Stage
IPO
Headquarters
Thousand Oaks, California
Founded
1980
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Simplify's Take
What believers are saying
- Q2 2026 revenue rose 10% to $10.1 billion, and guidance increased to $38.2 billion-$39.4 billion.
- Repatha sales jumped 37% to $953 million in Q2 2026, with U.S. prescriptions up 50%.
- MariTide advanced through multiple Phase 3 studies in 2026, supporting a 2027 obesity catalyst.
What critics are saying
- Prolia sales fell 32% in Q2 2026 as biosimilars attack Amgen’s legacy cash cow.
- FDA proposed withdrawing Tavneos in April 2026, signaling regulatory risk from integrity and efficacy issues.
- Olpasiran now faces Novartis pelacarsen failure scrutiny; a negative 2028 OCEAN(a) readout would crush Lp(a) upside.
What makes Amgen unique
- Repatha, Evenity, and Uplizna diversify Amgen beyond one blockbuster, per August 2026 sales.
- MariTide targets quarterly or eight-week dosing, unlike Lilly and Novo Nordisk weekly injections.
- Amgen’s 2027 Hyderabad Science and Innovation Center expands AI-enabled drug discovery globally.
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Benefits
Professional Development Budget
Conference Attendance Budget
Company News
Amgen trades at $393 per share, representing a trailing multiple of 23.3 times adjusted earnings. The biotech faces declining sales from Prolia and XGEVA, down 33% year-over-year to $1.1 billion in Q2 2026, due to biosimilar competition. Six key growth medicines grew 26% year-over-year, accounting for nearly 70% of Q2 product sales. Analysts forecast the forward multiple at 17.0 times for fiscal 2026 and 16.1 times for 2027. However, consensus assumes expanding profit margins whilst Amgen increases spending. Non-GAAP research spending is set to grow in high single digits for 2026, funding nine Phase III trials for MariTide, its obesity treatment candidate. Management warned of meaningful operating expense increases in Q3 2026. The valuation depends on margin expansion materialising during this investment phase.
Amgen faces heightened scrutiny for its experimental heart drug olpasiran after rival Novartis's pelacarsen failed to reduce major cardiovascular events in a Phase 3 trial, despite successfully lowering lipoprotein(a) levels. The setback demonstrates that improving laboratory biomarkers may not translate to better patient outcomes. Amgen's OCEAN(a) outcomes study has enrolled 7,297 participants and is tracking heart-related deaths and procedures over roughly five years. While olpasiran uses a different design and may target different patients, pelacarsen's failure removes assumptions about the commercial value of lowering Lp(a). Amgen's shares traded at $437.23, sitting 19.54% above its estimated fair value of $365.76. The company reported $10.1 billion in second-quarter revenue and $3.5 billion in free cash flow.
Jim Cramer highlighted Amgen's cholesterol drug Repatha as a key driver behind the company's 31% year-to-date rally, calling it an overlooked catalyst by Wall Street. The injectable treatment, administered every two weeks, reduces death risk by 20% in patients at high risk for heart attack or stroke. Repatha generated $953 million in second-quarter sales, up 37% year-over-year. US new prescriptions surged over 50%, split evenly between cardiologist use and primary-care adoption for high-risk patients. Cramer noted the drug works against diabetes and high cholesterol, though insurance reimbursement has posed challenges. Amgen trades at a forward PE of 19, compared to Eli Lilly's 32, whilst outperforming Lilly's 10% gain this year. Repatha is one of six growth drivers representing nearly 70% of Amgen's product sales. The company raised full-year revenue guidance to $38.2-$39.4 billion.
Amgen shares jumped 3.5% to $440.08 on Wednesday as healthcare stocks reached record highs. The biotech company reported second-quarter revenue of $10.1 billion, up 10%, whilst GAAP earnings surged 65% to $4.37 per share. Twenty-two of Amgen's medicines posted double-digit sales growth, with seventeen products generating over $1 billion in annualised sales. Six key growth products climbed 26% and now account for nearly 70% of product revenue. The rally came as investors rotated into healthcare following excitement around Merck and Moderna's melanoma breakthrough. However, Amgen now trades at a 19% premium to its fair value estimate of $365.04, putting pressure on execution as some products like Prolia face headwinds.
Amgen and Regeneron could benefit from surging demand for GLP-1 drugs, which traditionally treated diabetes but now address obesity and obstructive sleep apnea. Amgen's stock is up 27% this year, with second-quarter revenue rising 10% year-over-year to $10.1 billion. The company is testing MariTide, an investigational GLP-1 medicine, in phase 3 studies for weight management and diabetes. MariTide could be administered monthly or less frequently, offering a convenience advantage over current daily or weekly treatments. Regeneron is also positioned to capitalise on the GLP-1 market expansion. Both companies present alternatives to current market leaders Eli Lilly and Novo Nordisk for investors seeking exposure to the growing GLP-1 drug category.