Senior Manager GCP Auditing - UK
About the job
- A bachelor’s degree and 8+ years of relevant industry experience are required.
- At least 5 years of direct Good Clinical Practice audit experience are required.
- Expert knowledge of Food and Drug Administration regulations, European Union regulations, International Council for Harmonisation guidance, and Good Clinical Practice requirements is required.
- Experience conducting process, site, vendor, and partner audits is required.
- Experience with regulatory inspections involving investigator sites, sponsors, or Contract Research Organizations is required.
- Ability to independently manage complex GxP compliance issues and high-value priorities is required.
- Strong leadership skills and experience interfacing with senior leaders are required.
- Project management, stakeholder management, collaboration, and negotiation skills are required.
- Strong problem-solving, written communication, and verbal communication skills are required.
- Ability to work independently, take initiative, and perform effectively in ambiguous environments is required.
- High attention to detail, accuracy, and organizational awareness are required.
- Willingness to travel 30–40% domestically and internationally is required.
- Lead end-to-end Good Clinical Practice audits across internal and external global activities.
- Schedule, conduct, report, and follow up on routine and directed audits.
- Develop and execute risk-based audit programs for assigned clinical studies.
- Identify compliance issues and drive process improvements and standardization.
- Represent Quality Assurance on complex compliance projects and initiatives.
- Interpret policies, standards, and regulations to address critical issues.
- Support regulatory inspections and inspection room activities.
- Collaborate with Global Development teams, external partners, and quality stakeholders.
- A master’s degree is preferred.
About the company
Regeneron Pharmaceuticals develops and commercializes medicines for serious diseases, with a focus on cancer, eye diseases, allergic and inflammatory diseases, and infectious diseases. Its products come from using proprietary research capabilities and technologies to discover and develop therapies, often in collaboration with academic, research, and industry partners. Revenue comes from selling approved medicines and from licensing its technologies and entering co-development and co-commercialization partnerships. The company works with healthcare providers and regulators to ensure treatment delivery and safety. Its goal is to improve patient outcomes by bringing life-transforming medicines to market through rigorous R&D and strategic collaborations, maintaining leadership in biopharmaceutical innovation.
Company Size
10,001+
Company Stage
IPO
Headquarters
Town of Mount Pleasant, New York
Founded
1988
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Simplify's Take
What believers are saying
- Sanofi paid $1 billion upfront, with up to $7 billion more for Regeneron's immunology pipeline.
- Q2 2026 revenue rose 17% to $4.3 billion; Dupixent sales hit $6.0 billion.
- Libtayo and EYLEA HD both posted record sales in Q2 2026, widening diversification.
What critics are saying
- EYLEA biosimilar competition starts in January 2027 after Samsung's settlement.
- Regeneron faces a 2026 SDNY securities class action over the failed fianlimab melanoma trial.
- Dupixent's patent cliff later this decade threatens the company's biggest profit pool.
What makes Regeneron Pharmaceuticals unique
- VelocImmune keeps generating partnered immunology assets; Sanofi renewed the alliance on October 1, 2026.
- Dupixent remains Regeneron's engine, with over 1.5 million patients across nine indications.
- EYLEA HD conversion shows platform strength; U.S. sales hit $596 million in Q2 2026.
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Benefits
Health Insurance
Wellness Program
Paid Vacation
Equity Awards
Annual Bonuses
Flexible Work Hours
Growth & Insights and Company News
6 month growth
10%1 year growth
12%2 year growth
12%Regeneron Pharmaceuticals may get its next boost from an old deal rather than a new drug. The company finished repaying a balance to its partner Sanofi, and since the third quarter of 2026 it has recorded its full share of profits from their collaboration. Regeneron expects Sanofi collaboration revenue to step up as a result, though that remains a forecast. The repayment cut reported revenue by about $930 million in 2025 and $530 million in the first half of 2026. Revenue from the collaboration already hit a record $2.2 billion in the second quarter. A step-up matching the 2025 loss would add about 6.5% to the company's 2025 revenue of $14.3 billion. Dupixent sales reached $6 billion worldwide in the quarter, up 38% at constant currency, but growth should moderate in the second half.
Regeneron's rare disease drug shows zero new abnormal bone growth in extended trial - REGN stock heads for best day in over A month. Published: Oct 13 2026, 12:15 AM IST * FB * TW * Linkdin * Whatsapp * GNFollow Us The firm's Pasatru drug was approved by the FDA in August, after trial results showed at least a 90% reduction in new abnormal bone lesions after 56 weeks. * The Phase 3 Optima trial enrolled 63 adults who received Pasatru or a placebo every four weeks. * A higher dose recorded one disease flare-up, compared with 17 in the placebo group. * The findings were presented at the American Society for Bone and Mineral Research. Regeneron Pharmaceuticals (REGN) reported encouraging long-term results for its recently approved rare disease drug on Monday, with patients showing no new abnormal bone growth during an extended Phase 3 trial. REGN shares were up about 2.8% and heading for their best day in over a month. What did the trial show? Regeneron's Pasatru treats fibrodysplasia ossificans progressiva (FOP), an extremely rare condition in which muscles, tendons and other soft tissues gradually turn into bone. The Phase 3 Optima trial enrolled 63 adults who received Pasatru or a placebo every four weeks. Between weeks 56 and 84, patients taking Pasatru developed zero new abnormal bone lesions, compared with nine in the placebo group. The findings were presented at the American Society for Bone and Mineral Research (ASBMR). Regeneron plans new study for children. The FDA approved Pasatru in August, following earlier trial results showing at least a 90% reduction in new abnormal bone lesions after 56 weeks. European regulators are currently reviewing Pasatru. The drug works by blocking Activin A, a protein involved in abnormal bone formation. Regeneron plans to begin another Phase 3 study, Optima 2, involving children and adolescents later this year. REGN's pipeline includes cancer, eye disease treatments. Beyond Pasatru, Regeneron is expanding its broader drug pipeline, which includes treatments for cancer, eye diseases and inflammatory conditions. The biotech firm recently expanded its partnership with Sanofi (SNY) to develop four new long-acting antibody treatments for inflammatory diseases. Under the deal, Regeneron will receive $1 billion upfront and could earn an additional $7 billion if the treatments meet certain development, regulatory, and sales targets. The companies will share development costs and split future profits equally. The company reported about $17.8 billion in cash and marketable securities as of June 30. Separately, BofA raised its price target on Regeneron to $908 from $891 and kept a 'Buy' rating. This implies a 19% upside from current levels. Retail remains bullish on REGN. Despite the recent run, retail sentiment on Stocktwits surrounding REGN remained 'bullish' over the past 24 hours. The stock is down around 1.4% so far this year, underperforming the broader State Street SPDR S&P Biotech ETF's (XBI) roughly 25% gains. Also read: Microsoft Looks In-House To Power Its AI Ambitions - CEO Nadella Calls It 'Our Biggest Bet Yet On Our Own Silicon' For updates and corrections, email newsroom[at]stocktwits[dot]com.< Stay updated with all the latest Business News, including market trends, Share Market News, stock updates, taxation, IPOs, banking, finance, real estate, savings, and investments. Track daily Gold Price changes, updates on DA Hike, and the latest developments on the 8th Pay Commission. Get in-depth analysis, expert opinions, and real-time updates to make informed financial decisions. Download the Asianet News Official App from the Android Play Store and iPhone App Store to stay ahead in business. 0 Comments / 0 New
Regeneron Pharmaceuticals said its drug Pasatru (garetosmab-grts) showed sustained results in adults with fibrodysplasia ossificans progressiva (FOP), an ultra-rare genetic disorder that causes bone to grow in muscle and connective tissue. The 84-week data from the Phase 3 OPTIMA trial were presented at the American Society for Bone and Mineral Research annual meeting. From week 56 to week 84, patients on Pasatru had no new abnormal bone lesions, against nine for placebo. New flare-ups numbered one on the 10 mg/kg dose, 14 on the 3 mg/kg dose, and 17 on placebo. The trial enrolled 63 adults. Skin and soft tissue infections rose with dose but all resolved, and no patients stopped treatment because of them. The US Food and Drug Administration recently approved Pasatru. A trial in children and adolescents is planned to begin later this year.
TODAY: President Trump rallies in Syracuse. Commentary. If you are covering President Trump's rally in Syracuse today, please consider this statement from the Republican National Committee: "Kathy Hochul is the worst governor in America and wants to keep New York a high-tax, pro-crime, sanctuary state. New Yorkers are sick of it and fired up to welcome President Trump and Republicans like Bruce Blakeman who will fight for all New Yorkers by standing with law enforcement, lowering costs, and bringing back common sense." - RNC Spokesperson Kristen Cianci Background: President Trump And Republicans Delivered Historic Tax Cuts * The Working Families Tax Cuts saved each New Yorker an average $4,079 in taxes. * New York will see wages increase by up to $8,000 over the next four years. * The expanded SALT cap delivered $32.2 billion in tax savings. * 5% of New York workers benefit from no tax on tips. * Up to 62% of New York workers benefit from no tax on overtime. * 3.3 million seniors in New York benefit from no tax on Social Security. President Trump Is Delivering Major Investments Across New York * President Trump has secured $11.2 trillion in direct foreign investments that are fueling job growth, innovation, and opportunity. * Micron raised its planned U.S. investments to more than $250 billion through 2035 for its new semiconductor manufacturing plant in Clay, New York, fourteen miles from Syracuse. * Anheuser-Busch invested $9 million into its Baldwinsville, New York, brewery near Syracuse to increase production of its alcohol brands. * GlobalFoundries announced $16 billion in investment to increase domestic semiconductor production and advanced packaging capabilities, including at its Malta, New York facility. * IBM announced plans to invest $150 billion into the United States over the next five years, including into its manufacturing plant in Poughkeepsie, New York. * Regeneron invested $2 billion into a new drug manufacturing facility in Saratoga County, creating 1,000 new jobs. * Chobani announced a $1.2 billion investment in a new manufacturing facility in Rome, New York. Thanks To President Trump Violent Crime Has Fallen At Historic Rates * In 2026, in New York, murders fell by 48%, and New York City saw the fewest shootings and murders in recorded history. * Operation Tidal Wave 1.0 arrested two people in Albany, New York, during a fraud investigation that led to the seizure of over 130 illegal firearms. * Operation Tidal Wave 2.0 arrested over 40 people in Albany, New York, in connection with drug distribution and illegal firearms. * Francisco Javier Roman-Bardales, a high-ranking member of MS-13, was charged in the Eastern District of New York for narco-terrorism, racketeering, material support for terrorism, and alien-smuggling conspiracies. * Operation Rotten Apple arrested nearly 2,200 illegal aliens across New York, including murderers, rapists, pedophiles, drug traffickers, and violent criminals. * Operation Salvo arrested 54 people in an immigration enforcement surge in New York following the shooting of a CBP officer; among those arrested are members of transnational gangs responsible for drug and weapon trafficking and human smuggling.
A gene therapy treatment has restored hearing in children born deaf due to inherited OTOF gene variants. In a clinical trial, nine of 12 children with profound deafness gained meaningful hearing after receiving Otarmeni (lunsotogene parvec-cwha), developed by Regeneron. The treatment delivers a working copy of the otoferlin gene directly into the cochlea using a dual AAV1 vector. By 24 weeks, four patients achieved normal to near-normal hearing, whilst four others had mild to moderate hearing loss. Cincinnati Children's Hospital treated two siblings as part of the trial. Three-year-old Abdu went from hearing virtually nothing to normal range hearing within weeks. His one-year-old sister Sumaya also showed dramatic improvement. The therapy addresses OTOF-related congenital deafness, which accounts for approximately 1% of congenital deafness cases. Results were published in The New England Journal of Medicine.