Global Regulatory Lead Director — Biologics (Remote)
BioSpace
- Remote job
Immunocore seeks a Director of Regulatory Affairs to lead global regulatory strategy across development programs, including IND/CTA, BLA/MAA submissions, and FDA interactions. This role oversees US and international submissions and coordinates with global sites to ensure compliant, timely filings. The successful candidate will bring a strong biologics background, strategic leadership, and the ability to operate in a fast-paced, entrepreneurial environment while delivering regulatory guidance #J-18808-Ljbffr BioSpace
$177k - $278.08k
...therapies, including ADCs, complex biologics and small molecules. Our goal is to... ...patients worldwide.Join Takeda as a Director, Global Regulatory Lead Oncology where you will be part of the... ...hybrid" following Takeda's Hybrid and Remote Work policy.#LI-Hybrid#LI-AA1Takeda...Remote workMinimum wageLocal areaWorldwide- Scorpion Therapeutics is seeking a Senior Regulatory Affairs leader to oversee global filings and compliance for a late-stage ophthalmic biologic product with FDA approval and European marketing authorization. You will lead end-to-end submissions (BLA, MAA, INDs, CTAs)...Remote job
$189.5k - $235k
Vacancy Name Director, Regulatory Affairs-Global Regulatory Lead Vacancy No VN723 Employment Type Full Time Location of... ..., MD, Radnor, PA, Oxford, UK, Remote, US Department Regulatory Affairs... ...candidate will have experience gained in biologics and the preparation of late-stage...Remote workFull timeWork at officeLocal areaWorldwideNight shift- Angitia Biopharmaceuticals seeks a Director of Global Regulatory Affairs to drive regulatory strategy for development programs, coordinating with... ...clinical, CMC, safety, statistics, and operations. You will lead global submissions and health authority interactions,...Remote job
$222k - $303k
...every person who joins in. As a global biopharmaceutical company dedicated... ...: We’re looking for a Senior Director, Regulatory Affairs, Global Regulatory Lead (GRL) - Development Strategy to help... ...You’ll Work This is a fully remote role. It can be performed...Remote workFull timeLocal areaFlexible hours- Placements24 is seeking a Regulatory Affairs Manager to lead global regulatory efforts from a remote-based position. This role requires developing regulatory strategies, preparing dossiers, and engaging with health authorities to drive timely approvals and market access...Remote jobWorldwide
$148k - $194.3k
...for patientsTo strengthen our Global Advanced Analytics team, we are... ..., Raleigh or Boston) or Remote (up to 20% onsite presence) and... ...create with Integrated Insights Leads from early asset and late stage... ...ideally specialty pharma and biologic treatmentsDeep expertise in leveraging...Remote workPermanent employmentWork at officeLocal area$118k - $197k
...starts with animals!As a global leader in animal health... ...!Your Role: Global Regulatory Project LeadAs the Global Regulatory Project Lead, you will be a key individual... ...veterinary medicine, biology, infectious diseases,... ..., IN (Hybrid), or be a remote position for the right...Remote workFull timeSummer workLocal areaRelocationFlexible hours$132k - $172k
...RemoteBe a part of a global team that is inspired... ...vision of becoming a leading biopharmaceutical company... ...The Senior Manager, CMC Regulatory Affairs is responsible... ...activities for biologic products, with a strong... ...is expected to be 100% remote.Total Rewards Offerings...Remote workFull timeTemporary workWorldwide- ...About Freyr Freyr Inc. is a leading global Regulatory Solutions and Services... ...Job Title: Associate Director, Global RA Labeling Lead... ...Location: Princeton, NJ - Remote Job Description Role... ...plasma-derived therapies and biologics is preferred. ~ Bachelor...Remote workPermanent employmentFull time
$212k - $333.19k
...Senior Director, AIRx Discovery Biology Lead Takeda Research is constructing the Discovery Automation & Robotics... ...as “hybrid” by Takeda’s Hybrid and Remote Work policy Compensation and... ...Takeda Takeda is an industry-leading, global pharmaceutical company with an...Remote workMinimum wageFull timeLocal areaWorldwide- ...The Senior or Executive Director, Global Regulatory Strategy is a key leadership... ...architect of regulatory pathways, leads high-stakes health... ...frameworks This is a remote role operating from the US,... ...years of experience in drug/biologic regulatory affairs, including...Remote workFull time
- ...About Freyr Freyr is a global Regulatory Affairs and Life Sciences consulting... ...Location: Princeton NJ, - Remote Job Description: Key... ...CMC experience, with biologics or plasma-derived products preferred... ...ability to function as the lead interface with the FDA. ~...Remote workPermanent employmentFull timeLocal areaFlexible hours
$200.68k - $215.27k
...MAPOSITION: Senior Manager, Global Regulatory Affairs, Marketed ProductsPOSITION... ...assist the Global Regulatory Lead (GRL) and is accountable for... ...strategy. Up to 75% remote work is allowed. Up to 30% domestic... ...Pharmaceutical Science, Chemistry, Biology, or related field, plus 4...Remote workMinimum wageFull timeWork at officeLocal area$180k - $230k
...Position: Director, Global Regulatory Affairs Department: Development - Regulatory... ...Affairs Location: U.S (Remote) with up to 20% domestic... .... The Global Regulatory Lead serves as the primary regulatory... ...is currently studying 2 biologic product candidates in the...Remote workFull timeFor contractorsWork from homeOverseas$141.52k - $191.47k
...Strategy - Oncology Publication Lead, is accountable for developing... ...and oversee implementation of global and US scientific... ...Flexible work models, including remote work arrangements, where possible... ...to unlocking the potential of biology for patients suffering from serious...Remote workFlexible hours$117k - $190k
...economic opportunity for every member of the global workforce. Our products help people make... ..., Omaha, San Francisco, Sunnyvale or remote. At LinkedIn, our approach to flexible work... ...outcomes. As a Global Enablement Lead, LMS Sales Performance, you will design and...Remote workFor contractorsWork at officeWork from homeFlexible hours- ...Therapeutics is seeking a Senior Scientist, Product Lead CMC Regulatory Affairs for Synthetics and New Modalities... ...development. You will integrate disease biology, pharmacology, and clinical data to shape scientific strategy and global CMC approaches. You will lead cross‑...
$120k - $160k
...innovating at the speed of life. As a global leader in high-tech filtration... .... The US Export Controls Lead will be responsible for... ...reports to Pall Corporation’s Director, Global Trade Compliance and is... ...Compliance teamand will be fully remote.In this role, you will be required...Remote workPermanent employmentFull timeWork at officeWork from homeWork visaFlexible hours- Smith+Naphew is seeking a Director of Regulatory Affairs for the Advanced Wound Bioactives portfolio in a hybrid role. You will lead global regulatory strategies, mentor a two-site team... ...cross-functional collaboration across biologics, HCT/Ps and device-led combinations....
- CSL Behring seeks a Team Lead, Global Regulatory Affairs to drive CMC regulatory strategy for biological and non-biological products. This role collaborates with Global Operations, R&D, and QA to ensure timely, compliant submissions and lifecycle management. Ideal candidates...
- ...To scale a global team from 100 to 200+ within the next 12 months, the full-time Global Talent Acquisition Lead will design and optimize talent acquisition strategies, lead and mentor... ...to enhance the hiring process in a remote work environment. Key responsibilities...Remote workFull time
- Life Unlimited. seeks a Director of Regulatory Affairs for Wound products to design and lead global regulatory strategies and oversee a cross-functional team across two... ...of managing complex regulatory programs across biologics, HCT/Ps and device-led combinations. #J-18808...
- ...celebrating 30 years as an industry pioneer and a global leader in broker-neutral trading... ...Corporate IT is looking for a Corporate IT Lead to innovate and grow our Corporate... ....• Ability and Experience on Premise and Remote Desktop and Applications SupportDoes this...Remote workWorldwideFlexible hours
$192.4k - $302.39k
...and empower you to shine? Join us as a Global Medical Lead, Nephrology in our Cambridge, MA... ...strategies (e.g., Clinical, Commercial, Regulatory, PV, Health Economics and Outcomes, Market... ...accordance with Takeda’s Hybrid and Remote Work policy.Empowering Our People to ShineDiscover...Remote workMinimum wageWork at officeLocal area- ...driven cadence across regions.Acts as the global orchestrator of solution area priorities,... ...into a prioritized sales play portfolio.Lead the end-to-end sales play lifecycle (launch... ...is an E-Verify companySummaryLocation: Greenville, SC; Remote, EuropeType: Full timeRemote workFull timeLocal area
$211k - $264k
Revolution Medicines is a global, commercial-state oncology company dedicated to discovering, developing and delivering... ...rigor—all in service of patients.The Opportunity:The Director of Regulatory Affairs (Global Filing Lead) is accountable for driving preparation & execution...Full timeWork experience placementLocal areaWorldwide- ...status quo for the better. Chiesi Global Rare DiseasesChiesi Global Rare... ...you will doReporting to the Senior Director, Global Strategic Insights, the Insights Lead, AIM Franchise will be... ...offer flexible working arrangements, remote work options, and tax assistance...Remote workHourly payLocal areaRelocation packageFlexible hours
$192.4k - $302.39k
...you to shine? Join us as a Global Medical Lead, PDT Hematology (f/m/x) in... ...Science, Quality, Safety, Regulatory, Manufacturing, and Legal throughout... ..., Regulatory, Medical Director.Maintain knowledge base as... ...with Takeda’s Hybrid and Remote Work policy.Empowering Our...Remote workMinimum wageTemporary workWork experience placementWork at officeLocal area$190k - $284k
...Bitmoji, Saturn, and other digital services.SPECS is seeking a Global Industry Lead, Manufacturing to help define how augmented reality glasses... ...deliver measurable business value, with particular focus on remote expert assistance, digital work instructions, quality...Remote workFull timeLive inWork at officeLocal area
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