Global Regulatory CMC Doc Control Lead (Contract)
TechDigital Group
An established industry player is seeking a Quality Assurance Document Control Associate Specialist to support cGMP Document Control operations. This role involves managing GMP records, ensuring compliance with FDA documentation standards, and maintaining accurate records management. The ideal candidate will have a strong background in document control within a regulated environment, excellent communication skills, and the ability to thrive in a fast-paced setting. Join a dynamic team that values innovation and quality, and contribute to impactful projects that enhance operational efficiency and regulatory compliance. #J-18808-Ljbffr
- ...Sanofi is seeking a GRA CMC Lead in Morristown, NJ, responsible for managing global CMC regulatory strategy, developing relationships with Health Authorities, and collaborating with Global Regulatory Affairs. The ideal candidate has a BS/BA in a scientific discipline...Regulatory
- ...Eacademy Sanofi in Morristown, NJ is seeking a GRA CMC Lead to manage regulatory strategies for the R&D team. This role involves direct interaction... ...pharmaceutical sector. Join our innovative team to bring life-changing medicines to patients globally. #J-18808-Ljbffr...Regulatory
- ...required to work weekends. End date for this contract is 31 DEC 2024. PURPOSE AND SCOPE OF POSITION: The Quality Assurance Document Control (QADC) Associate Specialist supports the... .... Strong knowledge of cGMPs and domestic regulatory requirements Must complete tasks...Contract workRegulatoryWeekend work
- ...An established industry player is seeking a Global Product Quality Specialist to oversee documentation and change controls for clinical and commercial projects. This role requires a strong understanding of regulatory guidelines and the ability to manage multiple work...Regulatory
$254.53k - $308.43k
...Director, Real World Evidence Innovation Center Lead, Global Medical Working with Us Challenging.... ...of technical success External Control Arms: patient matching, propensity methods, eligibility alignment, and regulatory considerations Hybrid designs: integrating...RegulatoryFull time- Job title: GRA CMC Lead Location: Morristown, NJ About the Job As GRA CMC Lead within... ...Lead, Vaccines is responsible for the global CMC regulatory strategy definition, managing... ...Affairs entities. Participate in Change Control assessment. Ensure strong collaboration...RegulatoryLocal areaWorldwide
$175k - $180k
Global pharma business with startup operations in the US seeks a Financial Controller to spearhead their US finance operation. Our client is... ...US GAAP, taxation, and regulatory requirements Coordinating... ...Supporting pricing strategy, contract management, and invoicing activities...Contract workRegulatoryWork at officeWork from home$215k - $240k
...New Jersey, United States Contract type: Permanent Job ID:... ...future of dermatology by driving regulatory strategy for LEO Pharma's... ...commercial) to ensure alignment on global strategy via the GRT.... ...collaboration with the Global Regulatory Lead. ~ Manage the...Contract workRegulatoryPermanent employmentWork at officeLocal area- ...Title: AI Governance Lead Location: Warren,... ...Job Type: Full time/ Contract Job Summary: Role... ...functioning policies, controls, workflows, and an embedded... ...Translate regulatory expectations (AI risk,... ...professionals working for 1000+ Global Customers (including...Contract workRegulatoryFull time
- CVS Lead at Katalyst CRO The CVS Lead is responsible for leading... ...to ensure compliance with global regulatory standards. The role involves... ..., EMA, MHRA) Manage change control, deviation, CAPA related to... ...Senior level Employment Type Contract Job Function & Industries...Contract workRegulatory
$150k
...Sourcing and Category Lead for BPO and Debt Services... ...and delivering the global category strategy for... ...commercial negotiations, contract structuring, and value... ...supply, financial, regulatory, and operational risks... ...role, such as risk and controls, change and transformation...Contract workRegulatoryHourly payTemporary workWork at office- A global biopharmaceutical company is looking for an Associate Director of Regulatory Affairs to lead the regulatory strategies for Chemistry, Manufacturing, and Controls (CMC). You will prepare and manage regulatory submissions while collaborating with internal departments...Regulatory
- ...Morris Plains, NJ Contract Duration: 12-18 months... ...Associate Director in the Regulatory Affairs CMC Department. The successful candidate may lead a small team of RACMC specialists... ...contributes to local and / or global process improvements, which have...Contract workRegulatoryLocal area
$158.14k - $194.47k
...As Director, Quality Control you will be responsible... ...including testing at contract labs for drug substance... ...Technical Operations, QA, and CMC Regulatory Affairs to manage... ...objectives. Build and lead a high‑performing team... ...managing FDA and global regulatory inspections...Contract workRegulatoryTemporary workWork at officeLocal areaFlexible hours- ...Global Regulatory Lead Estimate start date July 7th At LEO Pharma, our mission transcends the conventional. We're on an ambitious path to become the leaders in medical dermatology worldwide. If you're ready to make a difference, this role is your gateway to a world...RegulatoryWorldwide
$122.25k - $176.58k
...Job title: Global Submission Lead ~ Location: Morristown, NJ / Cambridge, MA. About the job... ..., coordination, and tracking of regulatory Priority portfolio and Integration submission... ...Leads project teams to ensure the control of submission component receipt and workflow...RegulatoryWorldwideFlexible hours- A leading document management firm is looking for a candidate in South... ..., NJ, to oversee document control processes and lead teams in... ...requirements and familiarity with regulatory document management are... ...essential for success in this role. #J-18808-Ljbffr PSG Global SolutionsRegulatory
$238.89k - $289.48k
...with-us .Position SummaryThe Director, Global Trial Lead (GTL) is accountable for the strategic... ...alignment with business objectives, regulatory standards, and quality benchmarks. As... ...the highest value study level budgets, contracts, and scope of work (SOW) for CROs and...RegulatoryHourly payFull timeTemporary workPart timeFor contractorsSummer workLive inWork at officeLocal areaRemote workFlexible hoursShift work- A contract research organization is seeking a CVS Lead responsible for leading Computer System Validation activities for GxP-regulated systems. This position involves ensuring compliance with global regulatory standards, managing validation lifecycle activities, and coordinating...Contract workRegulatory
$190.8k - $300.3k
...continues to pose a significant global health threat with 1.3... ...Global Marketing, HIV PrEP will lead the development of the global... ...reviews and maintain version control and governance. Profit Plan... ...areas such as Legal, Compliance, Regulatory, Promotions and Global...RegulatoryFor contractorsLocal areaWorldwideRelocationVisa sponsorshipFlexible hoursShift work- ...Chemist (Contractor) in the Town of Newark, WI, to assist in leading technical efforts for pharmaceutical R&D. This role... ...validating analytical methods using HPLC and UPLC, supporting CMC testing, and preparing regulatory submissions. The ideal candidate will have a strong...Contract workRegulatoryFor contractors
- ...Scorpion Therapeutics is seeking an Associate Principal Scientist in Rahway, New Jersey, to drive CMC regulatory strategies for biologics. You will oversee authoring INDs, BLAs, and manage regulatory submissions, ensuring compliance with guidelines. The ideal candidate...Regulatory
$105k - $120k
...seeking a Prevailing Wage Manager to own and lead the company’s prevailing wage and pay... ...compliance requirements including contract language, payroll submission standards,... ...Drive alignment between field execution and regulatory requirements 7. Training & Enablement •...Contract workRegulatoryFor subcontractorWork at officeLocal area$95k - $120k
APM Terminals The HSSE Permit Controller Lead oversees the full lifecycle of high-risk work permits... .... Appetizer: At APM Terminals, a global leader in port and terminal operations,... ...adherence to APM Terminals standards and regulatory requirements Perform field audits, spot...RegulatoryFull timeFor contractorsWork at officeLocal area- ...external stakeholders: US and Global Medical Affairs, NA Corporate... ...Agreement Monitors, Legal, Regulatory, Finance, Ethics & Business Integrity... ..., Clinical Supply, Contract Research Organizations (CROs)... ...regulations.* Supportive of Co-leading the Medical Strategy Team (MST...Contract workRegulatoryLocal areaFlexible hours
- ...an experienced Field Quality Manager to lead project quality oversight on complex construction... ...and inspections to verify alignment with contract and quality requirements Identify... ...corrective action plans Manage document control, ensuring drawings, records, and test documentation...Contract workFull timeFor subcontractorLocal area
$154k - $182k
...Senior Manager, Regional Regulatory Lead-North America for Vaccines CSL Seqirus is a leading global vaccine company, dedicated to advancing and protecting public health... ...members, including GRAS Regions and Regulatory CMC. Proactively fosters and promotes effective...RegulatoryLocal area3 days per week- ...Procurement Leader Teva is a global pharmaceutical leader and the... ...responsibility will be to lead and execute procurement activities... ...spend Lead or support contract negotiations and management... ...requirements Liaise with Legal, Regulatory, Finance, IT and other...Contract workRegulatoryLocal areaWorldwide
$153.85k - $217.2k
Kenvue-1 is seeking a Senior Manager for Export Controls & Sanctions who will implement compliance solutions across the company. The ideal... ...skills. This fully remote role involves providing guidance on global regulations, managing export control license processes, and...Remote work- Sanofi is seeking a Global Submission Lead to oversee regulatory submission planning and coordination. This role involves ensuring that all submissions meet regulatory standards and are delivered on time. The successful candidate will collaborate across teams and manage...Regulatory
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