Global Regulatory CMC Platform Scientist — Hybrid
Jobleads-US
Lilly is seeking an Advisor/Sr. Advisor - Global Regulatory Affairs (GRA) – CMC Platform Regulatory Scientist to provide regulatory CMC support across modalities.
The role is based in Indianapolis or Boston (hybrid) and involves leading global regulatory strategies and submissions with cross‑functional teams. Ideal candidates have 5+ years in regulatory CMC and 7+ years in pharma/biotech; strong communication, negotiation, and problem‑solving skills are essential.
#J-18808-Ljbffr Jobleads-US$130.8k - $209.4k
...strategic, hands-on Senior Scientist to join the CMC Quantitative Sciences (QS)... ...problems. You will also support regulatory submissions and help shape... ...across the product, platform, and analytical method lifecycle... ...days, sabbatical, global recharge days, and a discretionary...PlatformRegulatoryPermanent employmentFull timeWork from home$109.2k - $174.6k
...Moderna is seeking a hands-on Scientist to join the CMC Quantitative Sciences (QS)... ...the product, process and platform, and analytical method lifecycles... ..., analytical, quality, regulatory, and digital teams to solve... ...days, sabbatical, global recharge days, and a discretionary...PlatformRegulatoryPermanent employmentFull timeWork from home$142.5k - $256.5k
...visionary Quantitative Scientist to join our Chemistry,... ...Sciences (CMC QS) team as a Principal... ...product lifecycle, from regulatory filings and lifecycle... ...pipeline, accelerate global impact, and uphold our... ...estimation.Project & Platform OversightOversee a portfolio...PlatformRegulatoryPermanent employmentFull timeSeasonal workWork from home$130k - $199k
...health. Our RNA medicines platform, PRISM, combines... ...seeking a self-motivated Scientist II/Sr. Scientist I,... ...Technology Services, CMC to join its Oligonucleotide... ...with Quality, Regulatory CMC, Analytical Development... ..., FDA, EMA, and other global health authority expectationsResponsibilitiesProcess...PlatformRegulatoryContract workTemporary workSummer workLocal areaRemote work- ...Job Title: Scientist – Oligonucleotide/Peptide... ...oligonucleotide platform and develop our... ...troubleshooting and authoring CMC section of INDs.... .../conjugation/hybridization steps.... ...participate in writing regulatory sections for INDs... ...IntelliPro is a global leader in talent...PlatformRegulatoryPermanent employmentContract workWork experience placement
$142.5k - $256.5k
...visionary Quantitative Scientist to join our Chemistry,... ...Sciences (CMC QS) team as a Principal... ...product lifecycle, from regulatory filings and lifecycle... ...pipeline, accelerate global impact, and uphold our... ...estimation. Project & Platform Oversight Oversee a portfolio...PlatformRegulatoryPermanent employmentSeasonal work- ...learn our oligonucleotide platform and develop our... ...troubleshooting and authoring CMC section of INDs. These... ...cleavage/conjugation/hybridization steps. Investigate new... ...in writing regulatory sections for INDs.Qualifications... ...Education: Associate Scientist 3/Engineer 2: Bachelor...PlatformRegulatory
- ...Reference26-26755Scientific - Scientist Job Title: Scientist Onsite/Hybrid: 100% Onsite Site... ...support in vivo delivery platform development; evaluate potency... ...partner teams (e.g., CMC) to coordinate experiments... ...Technical Writing (protocols, regulatory documents) Non-Technical...PlatformRegulatoryContract workImmediate start
$117k - $157k
...seeking a highly motivated Scientist II to join our... ...building state-of-the-art platform processes that improve... ..., Non-Clinical, and Regulatory teams to enable program... ...reports and contribute to CMC sections of regulatory... ...Biogen?We are a global team with a commitment...PlatformRegulatoryFull timeTemporary workLocal area$145.5k - $218.3k
...Summary:The Principal Scientist Aseptic Control is recognized... ...in Boston, MA (Hybrid eligible working arrangement... ...sites.Support of regulatory submissions and pre-... ...products in novel device platforms; this includes working... ...that align with global Health Authority regulatory...PlatformRegulatoryFull timeContract workSummer workRemote workFlexible hours2 days per week$188k - $259k
...seeking a Sr. Principal Scientist, Oral Drug Product... ...mentor on cross-functional CMC and asset teams,... ...manufacturing readiness, and regulatory submissions. This role... ...tools, knowledge platforms, or best practices across... ...Biogen?We are a global team with a commitment...PlatformRegulatoryFull timeTemporary workLocal area$142.5k - $256.5k
The Role:The Associate Director, Global Regulatory-CMC will be responsible for coordinating regulatory CMC activities for one or more products... ...2010, we have aspired to build the leading mRNA technology platform, the infrastructure to reimagine how medicines are created...PlatformRegulatoryPermanent employmentFull timeWork at officeWork from home$147.5k - $221.3k
...Summary:The Associate Director, CMC Quality Compliance and... ...forumsKnowledge and Skills:Knowledge of regulatory requirements and inspection... ...international travel possible Hybrid-Eligible RolesIn this Hybrid-... ...HybridCompany InformationVertex is a global biotechnology company that...RegulatoryFull timeSummer workRemote workFlexible hours2 days per week- Takeda in Boston, MA is seeking a Director Regulatory Site CMC to lead site-specific post-approval... ...requires 10+ years in biopharma with deep global HA regulatory experience, an advanced... ...teams. The position offers a hybrid work arrangement, competitive compensation...Regulatory
$184.6k - $277k
...DescriptionGeneral Summary:The CMC Quality Compliance Director is... .... Monitor and interpret cGMP regulatory guidelines and trends in the regulatory... ...Skills:Expert knowledge of global GMP requirements and... ...10% Travel may be required#LI-hybrid #LI-JS1At Vertex, we embrace continuous...RegulatoryFull timeWork experience placementSummer workRemote workFlexible hours2 days per week$177k - $278.08k
...to patients worldwide.This role is within the Global Regulatory Affairs (GRA) Chemistry Manufacturing & Controls (CMC) and Devices organization, and will contribute... ...world.This position is currently classified as "hybrid" following Takeda's Hybrid and Remote Work policy...RegulatoryMinimum wageLocal areaRemote workWorldwide$193.1k - $289.7k
...DescriptionGeneral Summary:The CMC Statistics Director (... ..., quality control, and regulatory submissions. This... ...comparability assessments, and global regulatory... ...with statistical software platforms including JMP, Minitab,... ...more.Flex Designation:Hybrid-Eligible Or On-Site EligibleFlex...PlatformRegulatoryFull timeSummer workRemote workFlexible hours2 days per week$142.5k - $256.5k
The RoleModerna is looking for an Associate Director, Global Regulatory Affairs, CMC, to join our team. This pivotal role will focus on preparing... ...10, we have aspired to build the leading mRNA technology platform, the infrastructure to reimagine how medicines are created...PlatformRegulatoryPermanent employmentFull timeWork at officeWork from home$184k - $200k
...Director, Pharmacovigilance Scientist Location: Remote or, Hybrid, Needham, MA Salary: $184... ...-tumor responses. Our platforms use genetically modified... ...Development, Clinical Operations, Regulatory Affairs, Data Management,... ...current knowledge of global pharmacovigilance...PlatformRegulatoryRemote work$49 - $54 per hour
...chemical cleavage/conjugation/hybridization steps. Investigate new... ...our existing oligonucleotide platform process. Collaborate cross... ...facilities and participate in writing regulatory sections for INDs.... ...Manufacturing and Controls (CMC) Equal Opportunity Employer...PlatformRegulatoryHourly payContract workTemporary workWork experience placement- Title: Senior Scientist, Drug Product Development & External... ...To: VP/Director, CMC About Judo Bio Judo... ...Targeting RNA Into KidnEy) platform, we use a proprietary... ...CMC documentation and regulatory submissions (e.g., IND... ...) to support global regulatory activities....PlatformRegulatoryLocal area
- Moderna is seeking a hands-on Scientist to join the CMC Quantitative Sciences (QS) team in Norwood,... ...decisions across the product, process and platform lifecycles. In this role you will... ...manufacturing, analytical, quality, regulatory, and digital teams to solve scientific...PlatformRegulatory
$161.5k - $218.5k
...transition by leading CMC team as necessary for the... ...Development, Regulatory, Technical Operations,... ...approaches for novel and non-platform molecules, including capture... ...biologics or complex/hybrid modalities.Excellent communication... .... We're proud to be a globally recognized top employer...PlatformRegulatoryFull timeTemporary workLocal areaFlexible hours$128k - $146k
...Position Summary The Scientist II, Analytical Development will... ...closely within AD/QC and with CMC teams to develop and optimize... ...summarize analytical activities for regulatory filing. Perform/guide... ...Oligonucleotide (EDO) platform is founded on over a decade of...PlatformRegulatoryFull time$117k - $157k
...member of myGwork – the largest global platform for the LGBTQ+ business... ...patients' lives. We are seeking a Scientist II to join our Analytical... ...cross- functionally with CMC, formulation, process... ...lifecycle management aligned with regulatory expectations. ~ Participate...PlatformRegulatoryFull timeTemporary workLocal area$168k - $268.4k
...us. The purpose of the Advisor/Sr. Advisor - Global Regulatory Affairs (GRA) –CMC Platform Regulatory Scientist role is to provide strategic, tactical, and operational... .... Location: Indianapolis or Boston (hybrid) Regulatory & Scientific Expertise Apply strong...PlatformRegulatoryFull timeFlexible hours$117k - $156.75k
...member of myGwork – the largest global platform for the LGBTQ+ business... ...presently looking to fill a Scientist II position within its Parenteral... ...sciences, quality, regulatory, and external manufacturing... ...development protocols, and other CMC documentation supporting regulatory...PlatformRegulatoryFull timeTemporary workLocal area$143k - $233k
...position will play a key role in regulatory strategy development and... ..., Manufacturing and Control (CMC) programs. Your Role: With minimal... ....Develop and execute CMC global submission plans and timelines... ...oncology. Our Dynamo platform integrates an array of leading...PlatformRegulatory$241k - $332k
...and a member of myGwork – the largest global platform for the LGBTQ+ business community. Please... ...About This Role: As the Head of Regulatory CMC - Biologics & Advanced Therapy... ...readiness and supply continuity. This is a hybrid role to be based at our Headquarters...PlatformRegulatoryFull timeTemporary workLocal area$94.4k - $114.39k
...motivated Senior Associate Scientist with strong expertise... ...development, and CMC strategies. Responsibilities... ...Support routine and platform analytical testing... ...reports, protocols, and regulatory documentation... ...also enjoy an annual Global Shutdown between Christmas...PlatformRegulatoryHourly payFull timeSummer workLive inLocal areaRemote workFlexible hours
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