Regulatory Affairs Intern - CMC (Biotech) | Remote
United States Digital Space LLC
- Remote job
BeOne Medicines Ltd invites applications for a Regulatory Affairs CMC Intern to support global regulatory submissions and knowledge management. The role offers exposure to CMC regulatory activities, data maintenance, and collaboration with QA, Supply Chain, and IT. The internship emphasizes learning drug development processes, regional regulatory differences, and contributing to preparation of CTD CMC sections for Health Authorities, while gaining biotech experience in a fast-paced environment. #J-18808-Ljbffr United States Digital Space LLC
$285k - $320k
...pioneered a “moneyball for biotech” approach, pooling... .... What You'll Do Lead CMC regulatory strategy and execution... ...This is a U.S.-based remote role that will require... ...Extensive Regulatory Affairs CMC experience within... ...skill development and internal mobility. We provide career...Remote workWork at officeFlexible hours$188k - $215k
...pioneered a “moneyball for biotech” approach, pooling... ...Associate Director, CMC Regulatory Sciences reports to... ...Development) and Regulatory Affairs to design and... ...standards Interface with International Regulatory Affairs,... .... A US‑based fully remote role may be considered...Remote workFull timeWork at officeLocal areaFlexible hours- ...Job Description DEPARTMENT: Regulatory Affairs LOCATION: Durham, NC, Fully Remote COMPANY: Humacyte Inc (Nasdaq... ...a Senior Associate, Regulatory CMC with deep expertise in biological... ...communications associated with U.S. and international regulatory inspections,...Remote workTemporary workLocal areaVisa sponsorship
- ...including occasional domestic and international overnight travel.Job... ...enterprise risk and global regulatory requirements (GxP, SOX, GDPR... ...Comfortable working in a hybrid/remote office environmentFlexible... ...providers but help medical, biotech, and pharmaceutical companies...InternshipRemote workTemporary workCasual workWork at officeMonday to FridayFlexible hoursShift workNight shift3 days per week
- A public Biotech company in Boston is seeking a Regulatory Affairs CMC Manager/Senior Manager to support biologic products' global development and registration. The ideal candidate will lead the submission of regulatory documentation, ensuring compliance with FDA and EMA...Suggested
- Anagram Therapeutics, Inc. is seeking an Associate Director of Regulatory Affairs CMC to lead regulatory CMC activities across our portfolio through all development stages in a fast-paced biotech environment. You will develop regulatory-CMC strategies, coordinate INDs/...
- ...Inc. is seeking a Senior Director, Regulatory Chemistry, Manufacturing, and Controls (CMC) to lead regulatory strategies... ...Executive Director of Regulatory Affairs and requires strong strategic thinking... ...-on execution in a fast-paced biotech environment. The position is full...Full time
- ...A leading biotech company is seeking a Talent Acquisition Partner Intern to drive high-volume recruitment efforts. This hybrid role combines remote work with onsite presence in Pennington, NJ. Responsibilities include managing recruitment cycles, enhancing employer branding...InternshipRemote work
$166.4k - $249.6k
## Associate Director, Regulatory CMC, BiologicsApplylocations: Boston, MAtime type: Full timeposted... ..., Chemistry, Pharmacy, Regulatory Affairs, or related life science field (... ...be designated as: 1. **Hybrid**: work remotely up to two days per week; **or select**...Remote workSummer workFlexible hours2 days per week$170k - $198k
...as Associate Director, CMC Statistician. The... ..., Stability, Quality, Regulatory Affairs, Manufacturing, and external... ...experience in biotech/pharma, excellent technical... ...state of control, trends, internal control limits, and... ...work independently in a remote, matrixed, and highly...Remote work$100k - $160k
...Statistician to join our CMC organization and... ...into clear, regulatory-defensible conclusions... ..., and Regulatory Affairs to design fit-for-... ...QC environment in biotech/pharma.... ...education, location, internal equity, and other... ...permitted by law. For remote-based positions, this...Remote workFull timeLocal area- Salt AI, based in Chicago, is looking for a motivated Applied AI Intern to assist the Chief Business Officer and the Sales Solutions... ...and implementing AI-driven solutions for the pharmaceutical and biotech industries. You will contribute to projects that leverage agent...InternshipRemote job
$275k - $300k
...BIOTHERAPEUTICSLakefront Biotherapeutics is a global biotech with offices in Belgium, Chicago and... ..., research and development teams, and regulatory affairs team, while developing into a broader... ...in our South San Francisco office and remote candidates will not be considered.WHAT...Remote workContract workWork at office$224.9k - $404.6k
...responsible for managing a team of CMC experts that prepare and... ...agency correspondence and regulatory applications. This position will... ...of domestic and international regulatory guidance documents... ...experience in the pharmaceutical/biotech industry8+ years of experience...Permanent employmentFull timeWork at officeWork from home$190.4k - $285.6k
...Chemistry Manufacturing Controls (CMC) leads a Regulatory CMC team responsible for... ..., Pharmacy, Regulatory Affairs, Pharmaceutical Sciences,... ...as: 1. Hybrid: work remotely up to two days per week; or... ...Innovation District and its international headquarters is in London....Remote workSummer workFlexible hours2 days per week- ...Therapeutics, based in Boston, is seeking an Associate Director for Regulatory Affairs CMC to oversee regulatory strategies for innovative gene... ...submissions. This position promotes a collaborative work environment with flexible remote options. #J-18808-Ljbffr Jobleads-USRemote workFlexible hours
- ...Clinical DevelopmentJob Sub Function: Regulatory ScienceJob Category:Scientific/... ...recruiting for a Principal Scientist, CMC Regulatory Affairs - Combination Products. This position... ...participation in selected due diligence, internal consultation, process improvement, training...Full timeLocal area
$205k - $268k
...Senior Director of Regulatory Operations is responsible... ...in a fast-paced biotech environment, with... ...can be on-site or remote.Duties/Responsibilities... ...with Regulatory Affairs Leads, Clinical Development, CMC, Pharmacovigilance,... ...teams composed of internal stakeholders and external...Remote workFlexible hours- ...patients worldwide. It's time for a career you can be proud of. Regulatory Affairs Senior Manager Regional Regulatory Lead Job Description How... ...this. Let's change the world. The Regulatory Affairs Manager CMC contributes to product teams and acts as product lead or...Ongoing contractLocal areaWorldwideFlexible hours
- Recursion, a clinical‑stage TechBio company, seeks a Director CMC Regulatory Affairs to lead regulatory strategy for small molecule programs across US, EU and ROW. You’ll coordinate internal and external contributors and drive region‑specific CMC documents (Module 2/3,...Remote job
- Aurion Biotech, Inc. in Cambridge, MA is seeking a Senior Scientist, Analytical Science &... ...review protocols, evaluate data, and ensure regulatory compliance for QC testing of cell therapy... ...across QC, Analytical Development, CMC, and QA teams to drive successful transfer...Remote job
$285k - $320k
BridgeBio is hiring for a CMC Regulatory Lead in San Francisco, responsible for leading... ...extensive experience in Regulatory Affairs CMC within the biotech or pharmaceutical industry and be adept... .... The position is hybrid, with remote work and occasional onsite requirements...Remote job$250k - $300k
Menlo Park, CARegulatory Affairs - Regulatory Affairs /Regular, Full... ..., global expansion, CMC Regulatory and other... ...small commercial-stage biotech environment.Reporting... ...education, location, internal equity, and other job-... ...permitted by law. For remote-based positions, this...Remote workFull timeLocal areaImmediate start$132k - $172k
...Position Summary:The Senior Manager, CMC Regulatory Affairs is responsible for providing strategic... ...to travel up to 10% domestically and internationally.All positions have an essential job... ...Diego. No role is expected to be 100% remote.Total Rewards Offerings:Travere provides...Remote workFull timeTemporary workWorldwide$132k - $172k
....Position Summary:The Senior Manager, CMC Regulatory Affairs is responsible for providing strategic... ...to build effective relationships with internal and external stakeholders.Ability to travel... ...Diego. No role is expected to be 100% remote.Total Rewards Offerings:Travere...Remote workFull timeTemporary work$161k - $180k
...the Senior Vice President, Regulatory Affairs the Associate Director, Quality... ...cross-functionally with internal teams and external contract... ...Manufacturing, and Controls (CMC) teams and Contract Manufacturing... ...weightsWork Environment:Remote: Home office; expected to travel...Remote workContract workTemporary workWork at officeLocal areaHome officeMonday to ThursdayFlexible hoursNight shift$211.2k - $281.2k
...looking for a Senior Director, Global Regulatory Affairs – Biotech Unit based in United States. This... ...requires deep expertise in FDA and international regulatory frameworks. You’ll... ...time off and wellness benefits. ~ Remote work opportunity within the United States...Remote workFull timeWork at officeImmediate startWorldwide$104.5k - $325k
...participate in MLR (Medical, Legal & Regulatory) reviews to ensure... ...including marketing, regulatory affairs, and compliance, to develop compliant... ...development and delivery of internal policies and training... ...firm, pharmaceutical company, biotech company, CRO or medical device...Remote jobFull timeFixed term contractFlexible hours$144.06k - $205.8k
...global leadership role in the Regulatory Affairs department for the Chemistry... ...Manufacturing and Controls (CMC) aspects of regulatory... ...work in cross-functional and international environment; detail- and goal... ...is based in Westborough, MA. Remote work from anywhere in the US...Remote workWork at officeLocal areaWork from homeWorldwide$220k - $250k
...Director, Regulatory CMC Remote Iovance Biotherapeutics aims to be the global leader in innovating... ...optimal development paths within internal cross-functional teams and with health... ...Minimum 10 years' experience in regulatory affairs Late-stage experience in oncology...Remote workWork at office
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Regulatory Affairs Intern - CMC (Biotech) | Remote. Be the first to apply!
- clinical research regulatory New York, NY
- regulatory law New York, NY
- regulatory scientist New York, NY
- regulatory technician New York, NY
- regulatory New York, NY
- regulatory coordinator New York, NY
- regulatory cmc New York, NY
- regulatory engineer New York, NY
- regulatory accountant New York, NY
- regulatory contract New York, NY



