Global Regulatory CMC Lead - Biologics & Non-Biol
BioSpace
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 BioSpace
- Team Lead, Global Regulatory Affairs x 2The Team Lead, Global Regulatory Affairs CMC - Biological & Non-Biol. Products is responsible for:Partnering closely with CSL’s R&D, Manufacturing, Quality, Regulatory Affairs stakeholders to address regulatory strategy challenges...RegulatoryFull timeLocal areaFlexible hours
- Merck & Co., Inc. is seeking a Senior Scientist (R3) REGULATORY CMC BIOLOGICS to lead regulatory CMC activities for biologics programs in a hybrid work environment in the United States. The role focuses on delivering regulatory milestones across product development and...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 package$71.9k - $113.2k
...DescriptionAssociate Scientist, Process Analytics Lab Lead, Biologics Drug Substance CommercializationJoin... ...skills to bring in new assays in our non-GMP laboratory. In addition, you will... ...with safety, environmental, quality, regulatory, and Process Safety Management...RegulatoryFull timeFor contractorsLocal areaFlexible hours$75k - $105k
...shop floor and laboratory systems in a globally distributed setting is highly desirable... ...presentations preferred Experience building and leading high-performing, innovative, and... ...in Project Management Knowledge of Regulatory Compliance Team Leadership & Development...RegulatoryFull timeWorldwide- ...Lead Global Financial FP&A Analyst Are you a finance professional who thrives in a dynamic, international environment? We are seeking... ...a trusted financial advisor across accounting, finance, and regulatory functions. Develop and present executive-level reports and...Regulatory
- ...through launch and lifecycle decisions. The role oversees Quality across CMC, Regulatory, R&D, MSAT, Manufacturing, and supply functions, ensuring patient impact and inspection readiness. You will lead the One Quality Voice at senior governance forums, drive risk-based...Regulatory
- GSK seeks a CMC regulatory lead to drive regulatory strategies for investigational, late development and early commercial products. You will... ...role requires a Bachelor’s in Life Sciences and 4+ years in global CMC regulatory work, with strong leadership and project management...Regulatory
$21.25 - $24 per hour
...quality, expertise, and innovation. As a leading global cannabis provider, our brands—including... ...Of Prussia, PA Job Type: Full Time | Non-Exempt Shift: Sunday to Thursday | 6:... ...operations, ensuring adherence to company and regulatory compliance (proper weighing, data...RegulatoryHourly payFull timeShift work$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...Regulatory$177.3k - $206.85k
...Cytokinetics seeks a Senior Manager in Regulatory Affairs CMC to lead chemistry, manufacturing, and controls regulatory submissions and strategy execution... ...-quality regulatory dossiers and maintain compliance with global pharmaceutical standards for small molecule programs....Regulatory- Merck is seeking a Director (Principal Scientist), Global Regulatory Liaison to design and implement worldwide regulatory strategies for Immunology programs. You will be the sole global contact, coordinating with FDA/EMA and regional affiliates to optimize labeling and...RegulatoryWorldwide
$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 week$71.9k - $113.2k
...Merck seeks an Associate Scientist to lead process analytics operations for biologics drug substance commercialization.... ...prioritization, and delegation of non-GMP analytical testing activities... ..., environmental, quality, and regulatory requirements Author and review...Regulatory- 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
- ...AtPresidio, we’re at the forefront of a global technology revolution, transforming industries... ...opportunity for a Security Practice Lead to join our Cybersecurity National Practice... ....Broad experience and understanding of regulatory framework and guidelines in the region are...RegulatoryFull timeFor contractorsLocal area
- ...connected by our shared purpose: leading the fight against MASH.... ...clinical 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
- GSK is seeking an experienced HR Business Partner to provide partnering for Global Regulatory Affairs within the R&D HR team. You will lead and support change programs, coach senior leaders, and apply data-driven insights to drive organizational effectiveness. Role emphasizes...Regulatory
- ...seeking a Director of Search & Evaluation to lead strategic sourcing and evaluation of... ...opportunity, coordinating scientific, clinical, regulatory, and commercial assessments to inform... ....About CSL BehringCSL Behring is a global biotherapeutics leader driven by our promise...RegulatoryFull timeRemote work3 days per week
$131k - $210k
...We are looking for a dedicated Lead Architect to join our talented... ...assure compliance with legal, regulatory, and IPS project requirements.... ..., research, or other "non-administrative" areas. All interviews... ...Berkshire Hathaway company, is a global leader in technical consulting...RegulatoryFor contractorsWork at officeFlexible hours- ...Pharmaceuticals seeks a Vice President to lead clinical development strategy... ...late-stage program oversight, regulatory interactions, and cross-... ...FDA, EMA, PMDA, and other global agencies; prepare and defend... ...clinical development, biostatistics, CMC, regulatory, and safety...Regulatory
- GSK US is seeking an HR Business Partner to support Global Regulatory Affairs within the Chief Medical Officer Organization HR team. This global role partners with senior leaders to drive change, culture, workforce planning and talent management across a complex matrix...Regulatory
$106.88k - $171k
...The Role at a Glance This position leads the operational execution and continuous... ...Translates complex technical, operational, and regulatory AI risk concepts into clear, actionable... ...permitted by applicable law. Pay is based on non-discriminatory factors including but not...RegulatoryWork experience placementWork at officeRelocation package3 days per week$120.38k - $192.6k
...design, modeling, assumption setting, analysis, and state filing/regulatory compliance for new products, as well as regular rate-setting (... ...listed range as permitted by applicable law. Pay is based on non-discriminatory factors including but not limited to work experience...RegulatoryWork experience placement3 days per week- ...: Allied Universal®, North America’s leading security and facility services company,... ...hiring a Senior Manager - Internal Audit, Global SOX. The Senior Manager of Internal... ...compliance program to ensure adherence to regulatory requirements and internal policies....RegulatoryWork at officeLocal area
$66k - $90k
Lead Specialist, Sterilization and Microbiology Exton, PA The Lead... ...utilizing international regulatory standards as well as ISO 1348... ...company sterilization sciences and biological safety systems and standards... ...we go beyond them. Join our global team powered by science,...RegulatoryHourly payContract workWork at office- ...Job Description Job Description Our client, a leading global specialty chemicals company, has exclusively retained Solutus Legal Search... ..., and other public disclosures. Monitor and analyze regulatory developments in securities law and corporate governance and provide...RegulatoryWork experience placementNight shift
- CSL Plasma Inc. is seeking a senior leader to implement the global Integrated Facilities Management (IFM) strategy across diverse sites. You will govern external partners, ensure compliance with SLAs, and deliver cost-effective, high-quality services globally. You will...
- Blue Cross Blue Shield Global Solutions is seeking a Manager- Client Management to lead a world-class team focused on client satisfaction, persistence, and profitability while supporting new business efforts. You will manage a book of business, prepare renewals, and communicate...
$190.8k - $300.3k
...Gastrointestinal and Genitourinary Strategy Lead for the U.S. Oncology Lung,... ...competitive intelligence, and global strategies into a... ...continuously optimize personal and non‑personal health care provider... ..., Commercial Operations, Regulatory, Legal, Finance, Field Sales,...RegulatoryFor contractorsLocal areaWorldwideFlexible hours
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