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
- Moderna Associate Director, Global Regulatory-CMC will lead regulatory strategies for biologics or small molecules across lifecycle stages. You will shape global CMC plans, align with development teams, and drive submissions. The role requires 5+ years in biologics CMC,...Suggested
$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... ...hybrid" following Takeda's Hybrid and Remote Work policy. #LI-Hybrid #LI-AA1...Remote workMinimum wageFull timeLocal areaWorldwide$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... ..." following Takeda's Hybrid and Remote Work policy. #LI-Hybrid #LI-AA1 Takeda...Remote workMinimum wageFull timeLocal areaWorldwide$230.4k - $345.6k
...to our patients and customers. Our global presence provides opportunity for all... ...regard for our employees. The Director, Global Regulatory Strategy Lead will provide strategic regulatory... ...regulated pharmaceutical industry (biologics or small molecule) required. Preferred...Remote workFull timeContract workLocal areaWorldwideRelocation- 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$258.68k - $313.46k
...the careers of those who do it. Sr Director, Global Regulatory Strategy, Neuroscience Will be a... ...regulatory staff as Global Regulatory Lead and US Regional Regulatory Lead on assigned... ..., site-by-design, field-based and remote-by-design. The model assigned to this...Remote workHourly payFull timeSummer workLive inLocal 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
$242k - $270k
...Director, Senior Global Regulatory Lead (Sr. GRL) Global Regulatory Strategy (GRS) Location: King of Prussia, PA | Waltham, MA | Maidenhead, UK... ...Experien ce Education Bachelor's degree in Pharmacy, Biology, Chemistry, Pharmacology, Clinical Medicine, or a...3 days per week- Candel is seeking an Associate Director, Regulatory Affairs to lead global regulatory strategies for oncology ATMP programs across US, EU, UK, Japan and other regions. You will partner with Clinical, CMC, Quality, Research and Commercial teams, manage regulatory submissions...Remote job
$220k - $250k
...Let’s build the future of medicine - together. Remote | Full-Time | $220,000 - $250,000 YOUR ROLE As a Global Regulatory Strategy Director at Enveda, you'll lead the development and execution of innovative regulatory strategies for our pipeline of first-in...Remote workFull timeWorldwideFlexible hours$89.42k - $120.98k
...to Bring the Future! Job Purpose Lead Honda's global Firewall Management team responsible for... ...with cybersecurity standards, regulatory requirements, and business objectives.... ...Workstyle ~ This is an onsite job. One remote workday per week may be possible with...Remote workFull timeTemporary workWork experience placementRelocation package$201.8k - $264.8k
...negotiates evidence with regulatory agencies.... ...on of new drugs, biologics/biotechnology and/... ...timelines. Support/ Lead (depending on... ...As a Regional or Global Regulatory Lead, initiate... ...We will consider remote candidates who are... ...range for the Director, Global Regulatory...Remote workWork at office3 days per week- Summit Therapeutics Inc. is seeking a Senior Director of Regulatory Affairs to develop and implement global IND/CTA strategies and lead preparations for global marketing applications (BLA/MAA) in oncology. The role requires extensive regulatory leadership, cross-functional...
- 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-...
$150k - $200k
...working, whatever they're working toward. The Opportunity: Global Tax Lead Tilt is hiring an International Tax Lead to own tax across... ...eligibility and permanent establishment risk, including for remote employees and contractors Partner with local finance teams...Remote workPermanent employmentFull timeFor contractorsWork at officeLocal areaWork from homeWorldwideFlexible hours$200.68k - $215.27k
...POSITION : Senior Manager, Global Regulatory Affairs, Marketed Products... ...assist the Global Regulatory Lead (GRL) and is accountable for... ...regulatory strategy. Up to 75% remote work is allowed. Up to 30% domestic... ...Science, Chemistry, Biology, or related field, plus 4 years...Remote workMinimum wageFull timeWork at officeLocal area- ...Are BioMarin is a leading rare disease... ...people’s lives, our global teams have delivered... ...operations. Senior Director, Corporate Counsel, Global Regulatory Affairs - HYBRID IN SAN RAFAEL CA OR REMOTE IN WASHINGTON DC... ...pharmaceutical, biotechnology, biologics, or life sciences...Remote workWorldwide3 days per week
$258.68k - $313.46k
...careers.bms.com/working-with-us](#). Sr Director, Global Regulatory Strategy, Neuroscience Will be a... ...regulatory staff as Global Regulatory Lead and US Regional Regulatory Lead on assigned... ...the capability centers. Employees in remote-by-design or lab-based roles may be...Remote workHourly payFull timeTemporary workPart timeFor contractorsSummer workLive inWork at officeLocal areaFlexible hoursShift work- ...company, regenerates life in depleted soils globally with naturally occurring,beneficial... .... Position Summary: The Global Regulatory Affairs Lead is responsible for defining and... ...strong plus. Location: Home-based / Remote (USA-based preferred for proximity to...Remote workLocal areaWork from homeShift work
$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$143k - $180k
...the better. Chiesi Global Rare Diseases... ...and operating rhythms, lead high-priority initiatives... ...the impact of Medical Directors, Field Medical Leaders,... ...policies and applicable regulatory requirements. Performance... ...Location USA (Remote), with travel to Chiesi...Remote workHourly payFull timeLocal areaRelocation packageFlexible hours$96.6k - $154.6k
...technologies. As part of our team, you’ll work with global leaders Universal Robots (UR) and Mobile... ...and Mobile Industrial Robots (MiR), is a leading provider of collaborative robots (cobots)... ...: Reporting to the Go-To-Market Director , this new global marketing function...Remote workFull timeWorldwideFlexible hours$230k - $260k
...with centralized governance. The world’s leading companies rely on Dataiku to operationalize AI... ...The role Location: US, East Coast remote · Reports to: VP, People Foundations You'll own Dataiku's global compensation, equity and benefits strategy. The...Remote workFull timeFlexible hours- Scorpion Therapeutics seeks a Senior Director of Regulatory Affairs to oversee global regulatory strategies for biologics development, with a focus on late-stage filings. The... ...for global interaction and oversight. You will lead IND, BLA, and sBLA submissions, develop...
- CSL is seeking a Senior Manager Global Regulatory Affairs CMC for Biological & Non-Biological products in the United States. You will define global regulatory... ...with regulators as an authorized official, and lead cross-functional teams across R&D, Manufacturing, Quality...
- ...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‑...
- Immunocore seeks a Director of Regulatory Affairs to lead regulatory strategy across multiple programs in Gaithersburg... ...interactions, coordinating with global teams to ensure compliant, timely... .... This role requires extensive biologics regulatory expertise and decisive leadership...
- CSL Behring in King of Prussia, PA seeks a Senior Manager Global Regulatory Affairs CMC—Biological & Non-Biol. Products to lead regulatory strategy and submissions for a dynamic product portfolio. You will partner with R&D, Manufacturing, Quality, and Regulatory Affairs...
- CSL, headquartered in King of Prussia, seeks a Senior Manager Global Regulatory Affairs CMC to drive regulatory strategy for biological and non-biological products. You will partner with R&D, Manufacturing, Quality, and Regulatory Affairs to meet evolving CMC requirements...
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