Global CMC Regulatory Leader for Small Molecules (Hybrid)
Madrigal Pharmaceuticals Inc
Scorpion Therapeutics seeks a Senior Director of Regulatory Affairs CMC to provide strategic and operational leadership for regulatory chemistry, manufacturing, and controls activities supporting clinical trials, market registrations, and post-approval submissions for biopharmaceutical products. Based in a hybrid setting in the US, the role will drive regulatory strategies across the product lifecycle, coordinate dossier content, and represent the company in global health authority meetings, #J-18808-Ljbffr
- ...Scorpion Therapeutics is seeking a Senior Scientist, Product Lead CMC Regulatory Affairs for Synthetics and New Modalities to guide regulatory... ..., and clinical data to shape scientific strategy and global CMC approaches. You will lead cross‑functional regulatory activities...Regulatory
- ...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...Regulatory
- 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...Regulatory
- 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...Regulatory
- Scorpion Therapeutics seeks an Executive Director of Regulatory Affairs Liaison in General Medicine to lead global regulatory strategy for ophthalmology programs,... ...proven track record of delivering regulatory milestones in a hybrid work environment. #J-18808-Ljbffr MerckRegulatory
- CSL Plasma in King of Prussia, PA is seeking a Senior Manager, Regulatory Submission. This hybrid role teams with Global Regulatory Submission Management to ensure timely, high-quality regulatory submissions across markets. You will coordinate with Regulatory, Project Management...Regulatory
- The Senior Manager Global Regulatory Affairs CMC - Biological & Non-Biol. Products is responsible for:Partnering... ...closely with cross-functional leaders in Global Regulatory Affairs CMC,... ...communication settings: one-on-one, small and large groups, among diverse styles...RegulatoryFull timeLocal areaFlexible hours
$258.83k - $293.48k
...Madrigal Pharmaceuticals seeks a Senior Director of Regulatory Affairs CMC to lead strategy and execution for chemical... ...approval stages. The role requires deep expertise in small molecule regulatory development and global health authority interactions....Regulatory$170.9k - $231.3k
...Associate Director, Regulatory Affairs CMC Development is responsible... ...and implementing global CMC regulatory strategies... ....This position is hybrid and primarily located... ...for innovative small molecules, biologics, and complex... ...About AlnylamWe are the leader in RNAi therapeutics...RegulatoryFull timeTemporary workWork at officeLocal areaFlexible hours$110k - $135k
212° Titans is seeking a Lead Global Payroll professional to oversee payroll processing across multiple countries for approximately 500... ...position offers a competitive salary range of $110K-$135K and a hybrid work schedule, fostering both collaboration and flexibility. #J-...$258.83k - $293.48k
...the right way.The Senior Director of Regulatory Affairs CMC provides highly strategic, tactical and... ...on CMC-related topics.Provides global regulatory input and support to quality... ...commercialization and life cycle management of small molecule products is required.Demonstrated...RegulatoryMinimum wageFull timeWork at officeLocal areaFlexible hours3 days per week$173.2k - $272.6k
...analytical characterization technologies to drive late-stage small molecule pharmaceutical drug product development and... ...preparation of Chemistry, Manufacturing, and Controls (CMC) documents for global regulatory submissions, and responses to regulatory questions.The...RegulatoryFull timeFor contractorsLocal areaFlexible hours$173.2k - $272.6k
...Commercialization Team (DCT) leader is-accountable for... ...stage-appropriate CMC development and... ..., operational & regulatory success or... ...with our company's Global and regulatory requirements... ...multiple large molecule programs across a... ...Work Arrangements Hybrid Shift Not...RegulatoryFor contractorsLocal areaRelocationVisa sponsorshipFlexible hoursShift work- ...CSL Plasma Inc. is seeking a Global Automation Engineering & Technology Head to define and execute the enterprise OT strategy for manufacturing... ...Data Analytics, driving capital projects and global team development while aligning with regulatory requirements and #J-18808-LjbffrRegulatory
$117k - $184.2k
...SENIOR SCIENTIST (R3) REGULATORY CMC - SYNTHETIC MOIETIES OF... ..., phase-appropriate global Regulatory CMC strategies... ...part of bio-conjugate molecules. Be accountable for... ...development experience in small molecules or other... ...Flexible Work Arrangements: Hybrid Shift: 1st - Day...RegulatoryFor contractorsLocal areaRelocationVisa sponsorshipFlexible hoursShift work- ...clinical lifecycle. The role requires independence, strong scientific expertise, and cross-functional collaboration with clinical development, translational science, biostatistics, and regulatory teams. Hybrid work with onsite presence is expected. #J-18808-LjbffrRegulatory
$177.3k - $206.85k
...Cytokinetics seeks a Senior Manager in Regulatory Affairs CMC to lead chemistry, manufacturing, and controls regulatory... ...regulatory dossiers and maintain compliance with global pharmaceutical standards for small molecule programs. Responsibilities Lead and coordinate...Regulatory- ...seeks a Distinguished Scientist to lead a cross-disciplinary team focused on engineering and optimizing T-cell engagers (TCEs) and small-molecule therapeutics for prostate cancer at Spring House, PA. You will drive a robust platform and mentor scientists in a highly...
$141.5k - $235.9k
...clinical team is reimagining its global talent model to support The... ...transitioning roles based on regulatory and contract requirements,... ...selection (BPO, captive, or hybrid), and readiness assessments to... ...change management across clinical leaders, business units, Legal,...RegulatoryFull timeContract workLocal areaWork from home- ...implementation, and oversight of the GDMS framework, training compliance, and quality management activities. Reporting to the Head of Global Data Management and Standards, this role sets the vision for the organization and ensures timely, high‑quality delivery of services...
$129k - $153k
...worldwide.Position Overview: Regulatory leaders who leverage regional regulatory... ..., scientifically sound, global, integrated regulatory vision... ...other regional, labeling and CMC GRAST members to ensure ‘One... ...regulatory outcomes.*** This is a hybrid position based in Waltham, MA...RegulatoryFull timeWorldwideRelocation package- ...Inc. in the United States is seeking a Senior Scientist (R3) Regulatory CMC to lead the regulatory chemistry aspects of ADC drug-linkers and... ...or related pharmaceutical development, with experience in drug-linkers, payloads, ADCs, and global submissions. #J-18808-Ljbffr...Regulatory
$210.4k - $331.1k
...an accomplished scientific leader to join the Quantitative Pharmacology... ...QP2 Oncology is part of the Global Clinical Development... ...ML) for key development and regulatory decisions.This role provides... ...regulatory expectations for small molecules, biologics including new modalities...RegulatoryFull timeFor contractorsLocal areaFlexible hours- ...Eight Eleven Group is seeking a Regulatory Program Manager to lead operational execution of regulatory strategy for its Oncology portfolio. The RPM will translate global regulatory plans into executable actions and coordinate cross-functional teams to ensure timely, high...Regulatory
- A global pharmaceutical organization is seeking a Contractor Quality & Regulatory Lead to oversee product quality and compliance for external manufacturers. This role demands... .... The ideal candidate will work in a hybrid model, balancing remote oversight with necessary...RegulatoryFor contractorsRemote work
- ...CSL Behring seeks a Director, Clinical Pharmacology in a hybrid role (King of Prussia, PA or Swiss site). You will lead pharmacology... ...The role requires a PhD/PharmD with 8+ years in industry, strong regulatory experience, and collaboration across Clinical Development,...Regulatory
$117k - $201.25k
...of our employees and recognize their merit. Job Function Regulatory Affairs Group Job Sub Function Regulatory Affairs Job Category... .... We are searching for the best talent for our Manager, Global Labeling Product Leader to be based in Raritan, NJ; Titusville, NJ; or Horsham,...RegulatoryLocal areaImmediate startWorldwide- ...Clinical Development Program Leader is a senior clinical leader responsible... ...decision-making.Lead early regulatory interactions (pre-IND,... ...senior clinical representative in global regulatory interactions (FDA,... ...development, biostatistics, operations, CMC, regulatory, and safety...RegulatoryFull timeLocal areaFlexible hours
- Johnson & Johnson is seeking a Global Process Owner (GPO), Product Quality Reporting, for Innovative Medicine Quality, to lead BPDR/FAR... ...across a global matrix. The GPO will partner with sites, Regulatory, MSAT and platform teams to deliver compliant, inspection-ready...Regulatory
- ...security leadership. Experience: 7-10 years in security leadership, 5+ years of team management, and strong regulatory knowledge. The position requires on-site leadership in King of Prussia, PA and collaboration with CSL Plasma and global security teams. #J-18808-Ljbffr CSLRegulatory
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