Global Regulatory CMC Lead - Large Molecules
Johnson & Johnson Innovative Medicine
Johnson & Johnson Innovative Medicine seeks a Principal Scientist (Manager) in Global Regulatory Affairs CMC to lead global regulatory strategies for large molecules, including vaccines and cell therapies. You will guide cross-functional teams, develop global dossiers, and ensure regulatory compliance across markets. The role emphasizes strategic thinking, robust scientific knowledge, and effective communication with health authorities; travel up to 10% may be required. #J-18808-Ljbffr Johnson & Johnson Innovative Medicine
$117k - $201.25k
...Learn more at Principal Scientist (Manager), Global Regulatory Affairs, CMC Purpose: The Principal Scientist of Global... ...supervisor. The primary responsibility is to lead the CMC regulatory activities related to large molecules in clinical development and post marketing...RegulatoryLocal area- ...years in the pharmaceutical industry, preferably with 1 year CMC regulatory experience Responsibilities will include, but are not limited... ...and with minimal supervision. Responsible for the global regulatory evaluation of CMC change controls with supervision....Regulatory
- ...complaint data, preparing governance materials, and coordinating with global stakeholders to drive insights and improvements. The candidate... ...reports, manage trackers, and support inspections, audits, and regulatory requests. A strong background in quality analytics and...Regulatory
$117k - $201.25k
...and recognize their merit.Job Function: Regulatory Affairs GroupJob Sub Function: Regulatory... ...Medicine R&D is recruiting for a Manager, Global Labeling Product Leader. This position is... ...Leader will be responsible for the following:Lead the development, revision, review,...RegulatoryFull timeLocal areaImmediate startWorldwide- ...Group Lead Intellectual Property Counsel Full-time Job Family... ...across North America (small and large molecules), overseeing the full IP... ...collaboration with Portfolio, R&D, Regulatory Affairs, Business... ...in coordination with R&D and global teams Lead IP due diligence...RegulatoryPermanent employmentFull timeWork at officeVisa sponsorship
$243k - $297k
Senior Medical Director - Global Medical Affairs Lead (GMAL), Dermatology Position SummarySun Pharma is seeking an experienced and strategic medical... ....• Collaborate with Clinical Development, Commercial, Regulatory, HEOR, Safety, Medical Information, and regional Medical...RegulatoryContract workFlexible hours$150.03k - $224.25k
...Associate Director, R&D Strategic Sourcing, will lead strategic sourcing efforts for key R&D... ...financial, operational, risk, quality, regulatory, and assurance of supply/services control... .... Specific experience in leading large, complex sourcing events in the R&D category...RegulatoryFull timeContract workTemporary workLocal areaFlexible hours$200k
A leading staffing solutions provider is seeking a Staff Veterinarian to support large animals in a dynamic research and biotech environment. The role requires a DVM/VMD degree... ...delivering veterinary care, ensuring regulatory compliance, and developing operational training...RegulatoryRelocation package- Americhem is a globally recognized designer and manufacturer of custom color masterbatch, functional... ...methods to deliver innovative, market-leading solutions. Integrate customer needs, competitive intelligence, regulatory requirements, and sustainability objectives...Regulatory
$254.53k - $308.43k
...deployable for the MEG, MAP & RWE and Global Medical teams. Specifically... ...Responsibilities Build & Lead the RWD Innovation Center... ..., eligibility alignment, and regulatory considerations Hybrid designs... ..., teams, or capabilities in large, complex organizations ~ Experience...RegulatoryHourly payFull timeTemporary workPart timeFor contractorsSummer workLive inWork at officeLocal areaRemote workFlexible hoursShift work- ...needs, we are dedicated to helping people lead longer and healthier lives. We are... ...litigations in North America (both small and large molecule) and be responsible for the entire life... ..., R&D, Business Development, and Regulatory Affairs is required. Responsibilities Manage...RegulatoryPermanent employmentWork experience placementWork at officeVisa sponsorship
$144.16k - $216.24k
...difference, there’s only one choice. Global Consolidated Customer Data & AI Lead The Global Consolidated... ..., licensing terms, and applicable regulatory requirements in partnership with Legal... ...with the ability to apply them in large commercial organizations operating...RegulatoryLocal area- ...Innovative Medicine seeks a Transcend Deploy Sr Analyst to lead the global deployment of Quality Management capabilities using SAP S/4HANA... ...systems, ensuring end-to-end release, testing, and regulatory compliance. The role requires up to 50% travel domestically...Regulatory
- Jobtailor in Titusville, NJ seeks a seasoned SAP/Value Stream Lead to deploy a global functional template on S/4HANA, ensuring Clean Core adoption and regulatory compliance. You will coordinate SMEs, IT, and validation teams to align scope, timelines, and business readiness...RegulatoryRemote work3 days per week
$170k - $210k
...The Role We are seeking a Global Benefits Director to lead the design, implementation, and ongoing management... ...Ensure compliance with U.S. regulatory requirements (ACA, ERISA, etc.) UK &... ...welfare expertise Experience within a large professional services organization Working...RegulatoryLocal area- Johnson & Johnson is seeking a Global Template Owner - Quality Management - Clinical/R&D to lead consolidation of global processes and support the Transcend ERP upgrade. The role is hybrid and based in Titusville, NJ, with alternate locations across listed sites. You will...
$264.95k - $321.06k
...Value Chain Management Lead (VCL) - GO Teams is a senior... ...lifecycle by leading Global Operations (GO) Teams... ...supply chain, quality, regulatory, technical operations,... ...with Product Development, CMC, Regulatory, Commercial... ...experience leading large, complex matrix organizations...RegulatoryHourly payFull timeTemporary workPart timeFor contractorsSummer workLive inWork at officeLocal areaRemote workFlexible hoursShift work- Johnson & Johnson Innovative Medicine in Titusville, NJ, seeks an IM Transcend Global Template Owner - Quality Management for Clinical/R&D Quality. This hybrid role leads standardization and template design across markets and SAP S/4HANA. You will consolidate processes,...
- ...Management and Data Scouting and Relationship lead role/s to coordinate external data sources to... ...• Knowledge of data related pharmaceutical regulatory requirements and emerging trends and issues • Experience driving large, complex change eorts and to drive results through...RegulatoryWork at officeImmediate start
$164k - $282.9k
...aligns with overall enterprise objectives.Lead the design, engineering, and... ...practices and policies, ensuring compliance with regulatory and ethical standards (e.g., EU AI Act, GDPR... ...Strategy, Emerging Technologies, Engineering, Global Market, Inclusive Leadership, Leadership,...RegulatoryFull timeImmediate start$200k - $250k
...join AXIS Capital - a trusted global provider of specialty lines insurance... ...risks for the Middle Market & Large Complex risk with premiums of... ...Key Duties & Responsibilities:Lead and manage the east primary... ...of business and legal and regulatory guidelines, to include demonstrated...RegulatoryFull timeTemporary workFor contractorsWork at officeRemote work3 days per week$99.3k - $198.7k
...AmericaTime Type: Full timeAbbott is a global healthcare leader that helps people live... ...spans the spectrum of healthcare, with leading businesses and products in diagnostics,... ...lab results for millions of people. The Regulatory Labeling Lead will serve as the subject...RegulatoryWorldwideShift work$137k - $235.75k
...leadership and accountability for Data Management delivery on large or complex clinical development and/or strategic... ...staff/team compliance with department SOPs, policies, and regulatory guidance documents.Lead or contribute to the development and maintenance of departmental...RegulatoryFull timeLocal areaImmediate start$122k - $212.75k
...people leadership. You will directly own and lead the product team for a set of functional... ...standards, security, privacy, and regulatory (including GxP if applicable) requirements... ...experience owning data domains end‑to‑end in a large, federated organization Demonstrated...RegulatoryRemote work$120k - $202.5k
...Analytics (CyberDNA) team is seeking a Global Operational Excellence Lead to establish world-class operational... ...will ensure operational stability, regulatory readiness, continuous improvement,... ...continuous service improvement for large-scale mission-critical environmentsProven...RegulatoryFull timeTemporary workWork at officeLocal areaFlexible hoursShift work2 days per week$285k - $340k
Shape global access strategy for innovative therapies... ...offers the scale of a large multinational while providing... ..., Japan, Australia).· Lead pre-launch and launch... ...generation aligns with regulatory and commercial... ...delivers senior talent across CMC, Technical Operations,...RegulatoryPart timeLocal areaWorldwide$122k - $212.75k
...an assigned group of large molecules (biological) products.... ...Responsible For Represents Global Quality on the... ...Manufacturing, and Controls (CMC) and Value Chain (VCT)... ...assigned products. Leads a comprehensive... ...strategies, R&D strategies, regulatory strategies, etc....RegulatoryLocal areaImmediate startFlexible hours$97.5k - $126.5k
Company DescriptionRamboll is a global architecture, engineering, and consultancy company... ...Princeton, NJ office. Ramboll is hiring for a Lead Consultant to join the Mergers &... ...compliance support to clients across a variety of regulatory program areas including hazardous waste,...RegulatoryFull timeWork at officeLocal areaFlexible hours$347.12k
...serious diseases. We strive to create, champion and maintain a global workplace where individuals’ unique contributions are valued and... ...necessary for advancement of the product pipeline (e.g. Regulatory, ICH-GCP, Business Development, etc).• Participate in relevant...RegulatoryFull timeFor contractorsFixed term contractWork at officeRemote work$122k - $212.75k
...of the way. Learn more at .Transcend is a global business transformation program that will... ...a strategic and experienced Value Stream Leads to drive the implementation of the SAP S/... ...expertise, a strong understanding of regulatory and compliance requirements in the life sciences...RegulatoryFull timeFor contractorsWork experience placementLocal areaImmediate start
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