Global Regulatory Lead Director Biologics (Remote)
BioSpace, Inc.
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
$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 work
- ...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 work
$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$258.68k - $313.46k
...and the careers of those who do it.Sr Director, Global Regulatory Strategy, NeuroscienceWill be a key member... ...regulatory staff as Global Regulatory Lead and US Regional Regulatory Lead on... ...essential, site-by-design, field-based and remote-by-design. The model assigned to this...Remote workHourly payFull timeSummer workLive inLocal areaFlexible hours- ...Travere Therapeutics is seeking a Director, Technical Operations (Biologics CMC Technical Writing) to lead authoring of CTD Module 2 and Module 3 content for regulatory submissions, including BLA. This role partners with Regulatory Affairs, SME, Quality, Manufacturing...Remote work
$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- ...Location: North Carolina/Remote If you are... ...The Associate Director/Director/Sr. Director, Regulatory CMC reports to the... ...CMC compliance with global (both U.S. and ex-U... ...regulatory authorities). Lead the authorship and... ...in MSAT for MAB biological products. ~...Remote workFull timeContract workVisa sponsorshipWork visa
$130k
A leading logistics recruitment firm is looking for a Customs Director in Los Angeles. This remote role involves leading a team of customs entry writers, ensuring compliance with global trade regulations, and maintaining strong customer relationships. Candidates should...Remote job$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- ...Eastridge Workforce Solutions is seeking a Senior Regulatory CMC Lead to provide strategic Regulatory CMC leadership for a global biologics program. This role will lead CMC activities... .... Local Boston candidates are preferred; remote East Coast candidates will also be...Remote workLocal area
$230k - $250k
...be part of Team Olema.Our lead product candidate, palazestrant... ...access to a $15 billion global market opportunity. Our follow... .... About the Role As the Director, Global Regulatory Strategy Lead - Regulatory... ...requirements impacting drugs, biologics and devices Provide...Work at officeFlexible hours2 days per week- ...for the better. Chiesi Global Rare DiseasesChiesi Global... ...core member of Global Regulatory Team (GRT) and... ...the Global Regulatory Lead (GRL), defining and executing... ...Chemistry, Pharmacy, or Biologic Science. Graduate degree... ...working arrangements, remote work options, and tax assistance...Remote workLocal areaWorldwideRelocation packageFlexible hours
$212k - $333.19k
...proven track record of leading at least 3 discovery... ...programs to clinic, The Global Therapeutic Research... ...include experience with biologics and preferably across... ...pharmaceutical industry, including regulatory requirements and... ...Takeda’s Hybrid and Remote Work policy Takeda...Remote workMinimum wageFull timeLocal areaWorldwide- ...Therapeutics seeks a Senior Manager, CMC Regulatory Affairs to lead regulatory strategy for biologic drug development and lifecycle management. You will drive global CMC submissions and health... ...programs and rare indications. Based remotely with up to 10% travel, you will...Remote work
- ...Incyte Corporation seeks an experienced Regulatory CMC professional to manage submissions and... ...products, spanning small molecules and biologics from early development to post-approval.... ...The role requires liaising with FDA and global authorities, ensuring compliant, high-...
- ...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
- ...Lilly, headquartered in Indianapolis, Indiana, is seeking a regulatory CMC leader to drive strategic, tactical, and operational CMC activities... ...strategies, and provide timely regulatory advice to support global submissions and lifecycle planning. The role emphasizes deep...Remote work
- ...Vertex Pharmaceuticals LLC seeks a Regulatory Labeling Associate Director to lead labeling strategy and global labeling for one or more products, including CCDS, USPI,... ...functional labeling activities from Boston or remote. The role emphasizes strategic thinking, stakeholder...Remote work
- ...Ionis Pharmaceuticals, Inc. seeks an Associate Director, CMC Regulatory Affairs to lead global regulatory strategies for CMC across the product pipeline. You will collaborate with cross-functional teams and external partners to deliver compliant submissions on aggressive...Remote workWorldwide
- ...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...
$138.75k - $231.25k
...Global Regulatory Affairs Manager, Oncology We create a place where people... ...the optimal balance between remote and in-office work. Discover... ...accountable to the Global Regulatory Lead (GRL) and Global Regulatory... ...: Bachelor's degree in biological, pharmaceutical or...Remote workWork at officeLocal area- ..., we can consider remote East Coast) or Copenhagen... ...to : VP, Regulatory Affairs & Quality... ...with the body's own biology and stop bleeds before... ...The role As Director, Regulatory... ...shape and deliver global regulatory strategy... ...authorization. Lead regulatory interactions...Remote work
- Immunome, Inc. is seeking a Global Regulatory Lead to shape and execute regulatory strategies across our oncology portfolio. You will lead a cross-functional team, collaborate with regional leads and vendors, and partner with health authorities to align submissions with...
- ...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‑...
- ...seeking a stability program leader to manage global stability activities across product... ...facility. The role collaborates with QA, Regulatory, Development, Manufacturing, and Lab... ...submission. Ideal candidates have a biology/pharma background, strong communication,...Relocation package
$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 travel Reports... ...programs. The Global Regulatory Lead serves as the primary... ...is currently studying 2 biologic product candidates in the...Remote workFor contractorsWork from homeOverseas- Repertoire Immune Medicines is seeking an experienced Director of Regulatory Affairs to lead global regulatory strategy for Phase 1/2 oncology programs, based in Watertown, MA with in-office presence at least 3 days a week. The role will own INDs/CTAs, health authority...Work at office3 days per week
- Merck seeks a Director (Principal Scientist) Global Regulatory Liaison to lead the development and execution of worldwide regulatory strategies for Immunology programs. As the single global point of contact, you will work with FDA/EMA and affiliates to optimize labeling...Remote jobWorldwide
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