Uxbridge, England, United Kingdom · Hybrid
Build our future together: As an Associate Director you will lead the development and execution of global CMC regulatory strategies for the hematology and oncology portfolios. You will guide regulatory activities across …
Skills: CMC Regulatory Strategy, Regulatory Filing, Global Regulatory Authority Interaction, Compliance Assessment, Mentoring
Hyderabad, Telangana, India · Hybrid
Build our future together: Regeneron is founded on the belief that the right idea, combined with the right team, can lead to significant transformations. Our growing global network is dedicated to inventing, developing, …
Skills: External Data Acquisition, Data Transfer Specifications, Clinical Data Management, External Data Reconciliation, CDISC Standards
Uxbridge, England, United Kingdom · Hybrid
Build our future together: At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking an Associate Director, Global Patient Advocacy, Hematology-Oncolo…
Skills: Patient Advocacy, Stakeholder Engagement, Issues Management, Strategic Planning, Cross-functional Collaboration
Limerick, Munster, Ireland · On-site
At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. Regeneron is currently seeking a Temporary Environmental, Health and Safety Specialist to join our Environm…
Skills: EHS Management Systems, Incident Management, Risk Assessment, Regulatory Compliance, Emergency Planning
Warren, Michigan, United States · On-site
$84k–$137k/yr
The Senior Financial Analyst will be the dedicated contact in the Program Finance department providing support to our Global Development organization and relevant partners. This role ensures compliance with financial req…
Skills: Financial Analysis, SOX Compliance, Budgeting, Forecasting, Business Partnering
Tarrytown, Georgia, United States · On-site
$115k–$187k/yr
As Manager, R&D Thought Leadership & Reputation Communications, you will play a key role in shaping and executing integrated external communications that strengthen Regeneron’s reputation, advance our scientific narrativ…
Skills: Strategic Communications, Storytelling, Executive Communications, Project Management, Public Relations
United States · On-site
$88k–$169k/yr
Our Automation Engineers keep our cutting-edge process controls and process monitoring systems running at peak efficiency. We provide unsurpassed expertise in designing, developing, implementing, and optimizing Regeneron…
Skills: PLC Programming, HMI Design, DeltaV DCS, Allen-Bradley, Siemens Control Systems
United Kingdom · Hybrid
Regeneron is growing its newly established International Oncology organisation and is seeking a Sales Specialist to join the UK sales team. This role focuses on engaging oncology healthcare professionals, supporting effe…
Skills: Customer Engagement, Disease-led Selling, Concept-led Selling, CRM Systems, Account Planning
Belgium · Remote OK
We are seeking a dynamic professional to join our team as a Market Access Manager, overseeing end-to-end management of HTA submissions, price negotiations, and tender strategies in Belgium. This pivotal role ensures stra…
Skills: Market Access Strategy, HTA Submissions, Price Negotiations, Tender Management, Value Proposition Development
Tarrytown, Georgia, United States · On-site
$80k–$131k/yr
At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking an Senior Associate Scientist to join our Protein Expression Sciences team, assisting with o…
Skills: High Throughput Cloning, Automated Liquid Handling, PCR, DNA Isolation, Mammalian Cell Transfection
Warren, Michigan, United States · Hybrid
$155k–$253k/yr
Regeneron is founded on the belief that the right idea, combined with the right team, can lead to significant transformations. Our growing global network is dedicated to inventing, developing, and commercializing medicin…
Skills: External Data Acquisition, Vendor Oversight, Clinical Data Management, Data Reconciliation, People Management
Dublin, Leinster, Ireland · On-site
$102k–$165k/yr
The Associate Director, Global Development Quality Inspection Management (GDQIM) acting as an Inspection Management Lead (IML) is a key position that is responsible for the effective management of GCP, GVP and GLP inspec…
Skills: Inspection Management, GCP, GVP, GLP, Regulatory Agency Inspections
Limerick, Munster, Ireland · On-site
$54k–$88k/yr
At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. Regeneron is currently seeking a Senior QA Validation Specialist to join our Quality Assurance team. This p…
Skills: Qualification, Validation, Protocol Generation, Troubleshooting, Deviation Investigation
Warren, Michigan, United States · On-site
$115k–$187k/yr
Build our future together: The Manager, Global Site Start-Up Lead (SSU Lead) is responsible for driving the global execution of site activation for clinical trials, performing the role with moderate oversight to ensure e…
Skills: Site Activation, Vendor Management, Clinical Trial Management, Project Management, ICH-GCP Guidelines
Canada · Remote OK
At Regeneron, we believe that when the right idea finds the right team, powerful change is possible. As we work across our growing network to invent, develop and commercialize life-transforming medicines for people with …
Skills: KOL Engagement, Scientific Exchange, Clinical Trial Execution, Medical Insights Generation, Cross-functional Collaboration
Uxbridge, England, United Kingdom · On-site
Build our future together: At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking an Executive Director to join our Patient Safety team. The Execut…
Skills: Pharmacovigilance, Patient Safety, Signal Detection, Risk Management, People Management
Dublin, Leinster, Ireland · On-site
$173k–$288k/yr
Build our future together: At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking an Executive Director to join our Patient Safety team. The Execut…
Skills: Pharmacovigilance, Patient Safety, Signal Detection, Risk Management, People Management
Sleepy Hollow, Wyoming, United States · On-site
$38/hr–$63/hr
The Global Market Access Executive Assistant is primarily responsible for managing and providing administrative support to the Senior Vice President, Global Market Access, and their direct support team. Responsibilities …
Skills: Calendar Management, Travel Coordination, Expense Reconciliation, Meeting Planning, Stakeholder Management
United States · On-site
$79k–$151k/yr
The Principal Supply Analyst - Kinaxis Maestro will drive innovation in supply chain planning and execution. In this role, you’ll design, implement, and optimize solutions using the Kinaxis Maestro platform, helping deli…
Skills: Kinaxis Maestro, Supply Chain Planning, Demand Planning, Inventory Optimization, ERP Integration
Sleepy Hollow, Wyoming, United States · Hybrid
$255k–$425k/yr
The Executive Director, Global Procurement – Commercial Procurement will provide strategic leadership and direction with a focus on Commercial Communications Procurement. The role focuses on a very exciting part of Comme…
Skills: Strategic Leadership, Commercial Procurement, Category Strategy, Supplier Relationship Management, Contract Management
Uxbridge, England, United Kingdom • Hybrid
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Lead the development and execution of global CMC regulatory strategies for hematology and oncology portfolios. Manage regulatory filings, facilitate interactions with global authorities, and mentor CMC Regulatory Affairs staff.
Requires a bachelor's degree and at least 10 years of pharmaceutical/biotech experience, including 5+ years in CMC. Proven experience with biological products and interactions with the US FDA is highly valued.
As an Associate Director you will lead the development and execution of global CMC regulatory strategies for the hematology and oncology portfolios. You will guide regulatory activities across development stages, mentor CMC Regulatory Affairs (RA) staff, supporting cross-functional and external partners, and serving as a key liaison in regulatory authority interactions.
This is an Uxbridge based position and would you to be on-site 3 days per week and 2 days from home. A fully remote role is not possible for this position. If eligible, we can offer relocation benefits.
To be considered a bachelor’s degree with a minimum of 10 years of pharmaceutical/biotech industry experience, including 5+ years of relevant CMC experience. An advanced degree is preferred.
Proven track record supporting biological products through development and approval is a distinct advantage.
It is required to have a good understanding of current CMC worldwide regulations and guidelines.
Experience in interacting with the US FDA and other regulatory authorities. Experience with device regulatory requirements and development processes for combination products is a plus.
Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We are committed to building a workplace with an inclusive culture. Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law. Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship.
Where necessary, we disclose salary ranges for roles in all countries in which we operate. The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and experience. In some countries, collective bargaining agreements (CBAs) may apply and influence certain elements of pay or benefits. Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role: annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, insurance benefits (e.g. medical, dental, vision, life and disability), paid time off, and family support benefits. For additional information about Regeneron benefits in the U.S., please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/. For other locations, additional information will be provided during the recruitment process. If you have any questions, please speak with your recruiter.
Please be advised that at Regeneron, we believe we do our best work when we are together. For that reason, many roles are required to be performed on‑site. Please speak with your recruiter and hiring manager for more information about on‑site expectations for your role and location.
As part of the recruitment process, certain background checks may be conducted in accordance with the laws of the country where the position is based. The purpose of such checks is to verify certain information prior to the commencement of employment such as identity, right to work and educational qualifications.
For jobs in Canada: this posting is for an existing position.
At Regeneron we believe that when the right idea finds the right team, powerful change is possible. As we work across our expanding global network to invent, develop and commercialize life-transforming medicines for people with serious diseases, we’re establishing new ways to think about science, manufacturing and commercialization. And new ways to think about health. Connect with us so we can learn more about you, and you can learn more about our biopharmaceutical medicines. And join us, as we build a future we believe in. Please visit www.regeneron.com/social-media-terms for information on how to engage with us on social media. An important note about privacy: Regeneron is committed to your privacy and will not ask for sensitive personal information such as social security number, date of birth or bank account details via email or social media.
Offices: 777 Old Saw Mill River Road, Tarrytown, New York 10591, US · 81 Columbia Turnpike, Rensselaer, New York 12144, US · 110 Allen Road, Basking Ridge, New Jersey 07920, US · 1 Rockwood Rd, Sleepy Hollow, New York 10591, US · 2425 Matheson Blvd E, Suite 726, Mississauga, Ontario L4W 5K4, CA
At Regeneron we believe that when the right idea finds the right team, powerful change is possible. As we work across our expanding global network to invent, develop and commercialize life-transforming medicines for people with serious diseases, we’re establishing new ways to think about science, manufacturing and commercialization. And new ways to think about health. Connect with us so we can learn more about you, and you can learn more about our biopharmaceutical medicines. And join us, as we build a future we believe in. Please visit www.regeneron.com/social-media-terms for information on how to engage with us on social media. An important note about privacy: Regeneron is committed to your privacy and will not ask for sensitive personal information such as social security number, date of birth or bank account details via email or social media.
Offices: 777 Old Saw Mill River Road, Tarrytown, New York 10591, US · 81 Columbia Turnpike, Rensselaer, New York 12144, US · 110 Allen Road, Basking Ridge, New Jersey 07920, US · 1 Rockwood Rd, Sleepy Hollow, New York 10591, US · 2425 Matheson Blvd E, Suite 726, Mississauga, Ontario L4W 5K4, CA
