Global Regulatory CMC Lead - Biologics & Non-Biol
BioSpace, Inc.
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 have 5+ years in regulatory roles within biologics/plasma, strong leadership, and exceptional communication. The position involves cross-functional leadership and interaction with regulators to advance CSL’s portfolio. #J-18808-Ljbffr
Vacancy posted 4 days ago
Similar jobs that could be interesting for youBased on the Global Regulatory CMC Lead - Biologics & Non-Biol in King of Prussia, PA vacancy
- 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
- The Senior Manager Global Regulatory Affairs CMC - Biological & Non-Biol. Products is responsible for:Partnering closely with CSL’s R&D, Manufacturing, Quality... ..., and timely delivery.Demonstrated ability to lead cross-functional teams and collaborate effectively with...RegulatoryFull timeLocal areaFlexible hours
CSL
Valley Forge, Montgomery County, PA5 days ago $173.2k - $272.6k
...integrated stage-appropriate CMC development and... ...advancing the company's biologics portfolio.Correspondingly... ..., operational & regulatory success or timelines. Analyzes... ...with our company's Global and regulatory requirements... ...with proven ability to lead complex discussions,...RegulatoryFull timeFor contractorsLocal areaFlexible hoursMerck Sharp & Dohme (MSD)
West Point, PA5 days ago- ...Scorpion Therapeutics seeks a Senior Director of Regulatory Affairs CMC to provide strategic and operational leadership for regulatory chemistry... ...lifecycle, coordinate dossier content, and represent the company in global health authority meetings, #J-18808-Ljbffr...Regulatory
Madrigal Pharmaceuticals Inc
Conshohocken, PA3 days ago $173.2k - $272.6k
...Director-level role leading the Development and Commercialization Team for biologics at Merck. Responsible for end-to-end CMC strategy execution, process development, regulatory filings, and commercial manufacturing readiness across multiple sites. Responsibilities...Regulatory$129k - $153k
...worldwide.Position Overview: Regulatory leaders who leverage... ...scientifically sound, global, integrated regulatory... ...regional, labeling and CMC GRAST members to ensure... ...(including leading assigned tasks) while fostering... ...’s degree in Pharmacy, Biology, Chemistry, Pharmacology...RegulatoryFull timeWorldwideRelocation packageCSL
King of Prussia, PA5 days ago- ...Inc. in the United States is seeking a Senior Scientist (R3) Regulatory CMC to lead the regulatory chemistry aspects of ADC drug-linkers and... ...related pharmaceutical development, with experience in drug-linkers, payloads, ADCs, and global submissions. #J-18808-Ljbffr...Regulatory
HireLifeScience.com
North Wales, PA10 hours ago - ...expertise in discovery, development, and regulatory approvals is evidenced in our strong... ...strategic and hands-on Supply Chain Lead to lead global clinical supply operations across... ...continue to grow. As a key member of the CMC Biologics team, you will oversee the end-to-end...RegulatoryContract workWork at officeLocal areaWorldwideFlexible hours2 days per week
Avalo Therapeutics
Wayne, PA2 days ago - ...responsible for delivering a stage-appropriate CMC development and commercialization strategy for the biologics portfolio. The role emphasizes end-to-end execution... ...-informed decisions, collaborate across DS/DP/Regulatory/Quality and Supply Chain, and ensure cGMP compliance...Regulatory
- 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
- ...seeking a Site Security Business Partner to lead and coordinate security programs across... ...5+ years of team management, and strong regulatory knowledge. The position requires on-site... ...Prussia, PA and collaboration with CSL Plasma and global security teams. #J-18808-Ljbffr CSLRegulatory
- ...CSL Plasma Inc. is seeking a Global Automation Engineering & Technology Head to define and... ...for Enterprise OT platforms and lead governance, standards, and partnerships to... ...and global team development while aligning with regulatory requirements and #J-18808-LjbffrRegulatory
CSL
King of Prussia, PA4 days ago - Merck in Rahway, NJ seeks a Senior Principal Scientist, Regulatory Affairs Liaison to lead worldwide regulatory strategy for General Medicine programs... .... This role requires a track record of leading global regulatory teams, strategic oversight across regions, and...RegulatoryWorldwide
- West Pharmaceutical Services is seeking a Principal, Regulatory Affairs - Intelligence to lead regulatory intelligence across global frameworks with a focus on containment systems and drug constituents of combination products. The role translates intelligence into strategic...Regulatory
- GlaxoSmithKline is seeking a Global Regulatory Affairs Manager, Oncology, to lead regulatory strategies for oncology assets across multiple regions. You will work with GRL and TA Head to align plans with development strategies, ensuring timely submissions and robust regulatory...Regulatory
- ...Scientific Communications professional to develop and shape content across channels, aligning with Medical Affairs strategies and regulatory standards. You will partner with internal teams and external partners to support launch readiness and lifecycle medical...Regulatory
Madrigal
Conshohocken, PA5 days ago - A global pharmaceutical organization is seeking a Contractor Quality & Regulatory Lead to oversee product quality and compliance for external manufacturers. This role demands over 10 years of experience in GXP settings and requires expertise in regulatory affairs and quality...RegulatoryFor contractorsRemote work
$76k - $121.9k
...Compliance and Investigations Lead to join our Innovative... ...for deviation, non-conformance, assay-failure... ...and trends, supports regulatory gap assessments and change... ..., biotechnology, biologics, cell therapy, or gene... ...Manufacturing, and Control (CMC) Clinical Trial Protocols...RegulatoryWork at officeLocal areaJohnson & Johnson Innovative Medicine
Spring House, PA5 days ago- GSK is seeking a senior epidemiologist to lead respiratory epidemiology and real‑world... ...partner with clinical development, safety, regulatory, health outcomes, and external... ...advance science, technology and talent across global programs in a hybrid work setting. #J-18...Regulatory
- ...Inc. is seeking a Principal Scientist to lead biologics process development, scale-up, and tech transfer... ...process characterization, validation, and CMC strategies across global sites. The candidate will drive PPQ readiness, regulatory submissions, and continuous improvement in...Regulatory
- ...experienced Lab Automation Project Manager to lead planning, implementation, and delivery of automation initiatives across a global pharmaceutical R&D organization. You will... ...while ensuring data integrity and regulatory compliance. #J-18808-Ljbffr Nextonic Solutions...Regulatory
- GlaxoSmithKline seeks a Senior Director to lead Global Real-World Evidence & Health Outcomes Research for RSV vaccines. You will oversee... ..., pricing, and access while ensuring high-quality evidence supports regulatory and payer needs. #J-18808-Ljbffr GlaxoSmithKlineRegulatory
- ...Johnson & Johnson seeks a Senior Manager to lead global diagnostic strategies supporting oncology precision medicine drug development... ...diagnostic strategies aligned with clinical development and regulatory plans Independently lead defined diagnostic programs and workstreams...Regulatory
Johnson & Johnson
Spring House, PA10 days ago $258.83k - $293.48k
...Madrigal Pharmaceuticals seeks a Senior Director of Regulatory Affairs CMC to lead strategy and execution for chemical manufacturing and controls... ...deep expertise in small molecule regulatory development and global health authority interactions. Responsibilities Independently...RegulatoryMadrigal Pharmaceuticals
Conshohocken, PA20 days ago$258.83k - $293.48k
...team is connected by our shared purpose: leading the fight against MASH.Madrigal’s... ...the right way.The Senior Director of Regulatory Affairs CMC provides highly strategic, tactical and... ...Authorities on CMC-related topics.Provides global regulatory input and support to...RegulatoryMinimum wageFull timeWork at officeLocal areaFlexible hours3 days per weekMadrigal Pharmaceuticals
Conshohocken, PA7 days ago$359.23k - $431.27k
...Madrigal Pharmaceuticals seeks a Vice President to lead global medical strategy for its MASH portfolio, including the FDA-approved Rezdiffra... ...Knowledge of global healthcare systems, market dynamics, and regulatory environments Demonstrated ability with strategic planning,...Regulatory- ...Avalo Therapeutics seeks a strategic, hands-on Supply Chain Lead to guide global clinical supply operations from early development to... ...inventory, and global distribution while partnering with CMC, Quality, Regulatory, and Clinical Ops to ensure uninterrupted drug supply....Regulatory
Avalo Therapeutics
Wayne, PA3 days ago - ...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
Medasource
Spring House, PA3 days ago - Situated within the Global Risk & Security Division, the Counterparty... ...of financial statements, regulatory filings, credit disclosures, news... ...consulting-style presentations and lead stakeholder readouts that... ...communication for technical and non-technical audiences....RegulatoryFull timeWork experience placementWork at office
Vanguard
Malvern, PA5 days ago
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Global Regulatory CMC Lead - Biologics & Non-Biol. Be the first to apply!
Related searches
- regulatory engineer King of Prussia, PA
- clinical research regulatory King of Prussia, PA
- regulatory King of Prussia, PA
- regulatory law King of Prussia, PA
- regulatory contract King of Prussia, PA
- food regulatory King of Prussia, PA
- financial regulatory
- regulatory medical writer
- regulatory coordinator
- regulatory engineer