Regional Submissions Planner - AP Regulatory Operations
Merck Gruppe - MSD Sharp & Dohme
Merck Gruppe - MSD Sharp & Dohme is seeking a Specialist Regional Submissions Planner within GRACS, RRO. You will support regional regulatory submission planning for the AP region and contribute to cross-regional planning, ensuring timely regulatory and safety submissions for approval. You will manage submission plans independently across all product lifecycle stages, collaborate with stakeholders, and participate in process improvements or strategic initiatives in a multicultural, #J-18808-Ljbffr
- ...Job Description The Specialist Regional Submissions Planner will work within our Global Regulatory Affairs and Clinical Safety (GRACS... ..., in the Regional Regulatory Operations department (RRO), supporting... ...regional planning activities for the AP region while also contributing...OperationsRegulatoryFlexible hours
- ...seeks an Associate Principal Scientist, Regulatory Affairs to help develop and implement... ...portfolio. You will support regulatory submissions and agency communications in collaboration... ..., coordinating with Regulatory Operations, Clinical Safety, Labeling, and CMC, and...OperationsRegulatory
- ...Merck & Co. seeks a Director of Stability Operations in the Pharmaceutical Analysis and Digital Technologies (PADT) to lead an integrated... ...strategies enabling uninterrupted clinical supply and regulatory submissions while preparing for commercial transitions. The role...OperationsRegulatory
$117k - $184.2k
Job DescriptionSENIOR SCIENTIST (R3) REGULATORY CMC - SYNTHETIC MOIETIES OF ADCs AND BIOCONJUGATESPosition... ...Applications, post-approval submissions/variations, agency meeting background... ..., testing, quality, technical operations, or CMC product development.Preferred Experience...OperationsRegulatoryFull timeFor contractorsLocal area$142.4k - $224.1k
...DescriptionBrief Description of PositionThe Regulatory Affairs Headquarters Associate... ...global regulatory strategy and regulatory submissions including assisting in preparing submissions... ...as needed to colleagues in Regulatory Operations, Clinical Safety, Labeling, Regulatory...OperationsRegulatoryFull timeFor contractorsLocal area- ...functions, including time and cost unit operations, and cost tracking and reconciliation.... ...funding opportunities and development and submission of proposals.Identify recovery-related... .... Keeping up with ever-changing regulatory requirements, Governmental Accounting Standards...OperationsRegulatoryFull timeWork at officeLocal area
$90k - $100k
...Divisional Director of Residential Services in operating the program effectively and efficiently... ...clinical charts for compliance with regulatory guidelines. Develops and supervises... ...with your resume/application submission. Please visit us at EEO Minorities/Women...OperationsRegulatoryFull timeLive outMonday to Friday$173.2k - $272.6k
Job DescriptionStability Operations Director - Pharmaceutical Analysis and Digital Technologies... ...to support clinical development, regulatory filing execution, and successful commercial... ...supply, support global regulatory submissions, and ensure seamless handoffs to commercial...OperationsRegulatoryFull timeFor contractorsSecond jobLocal areaFlexible hours- ...NJ, seeks a Principal Specialist, Health Authorities, to shape global regulatory strategy for investigational and marketed products. You will prepare, review, and finalize Health Authority submissions and responses, ensuring compliance with local requirements. You will...RegulatoryLocal area
- ...Engineer (Plating and Water Treatment Operations)Position OverviewThe Technical Engineer... ...wastewater treatment operations to ensure regulatory compliance, product quality, and... ...environmental reports; prepare regulatory submissions and support inspections.Support chemical...OperationsRegulatory
$120k - $135k
...Registration Management (HRM) Business Process Operations group to help with the continued... ...products, compliance reporting, and submissions to the HA. This role will be involved in... ...evolving business needs and keeping pace with regulatory requirements. The objective of this...OperationsRegulatory- ...and excite you. Position Title: Operations Coordinator I What You’ll Do:... ...needed or required to meet customer and regulatory requirements Support critical Plant... ...have been expressly requested to make a submission for a specific job opening. No placement...OperationsRegulatory
- ...Clinical Supplies. You will manage a team of 10–12 scientists overseeing externalized analytical deliverables across Biologics, ADCs, and vaccines, ensuring regulatory compliance and seamless collaboration with internal Process, QA, and Manufacturing teams. #J-18808-Ljbffr...OperationsRegulatory
$94.7k - $157.8k
...Participation, and Emergency Planning and Response in 24/7 operation plant.Have support responsibility for PSM... ..., responsible for company interface with regulatory authorities for regulatory visits, requests and submissions for their area, with support from Area Managers...OperationsRegulatoryFor contractorsWork experience placementWork at officeFlexible hours- ...funding opportunities and development and submission of proposalsMay be required to... ...understand a wide range of funding sources, operational challenges and reporting requirements. Keeping up with ever-changing regulatory requirements, Governmental Accounting Standards...OperationsRegulatoryFull timeWork at officeLocal areaRemote work
- ...laboratory personnel, and other site stakeholders to support regulatory compliance, maintain accurate EHS records, analyze performance... ...projects independently as experience and familiarity with site operations grow. Support incident investigations, corrective action tracking...OperationsRegulatoryWork experience placementWork at officeLocal area
- ...functions, including time and cost unit operations, and cost tracking and reconciliation.·... ...opportunities and development and submission of proposals.· May be required to occasionally... ....· Keeping up with ever-changing regulatory requirements, Governmental Accounting Standards...OperationsRegulatoryFull timeWork at officeLocal area
- ...funding opportunities and development and submission of proposalsIdentify recovery-related... ...understand a wide range of funding sources, operational challenges and reporting requirements. Keeping up with ever-changing regulatory requirements, Governmental Accounting Standards...OperationsRegulatoryFull timeWork at officeLocal areaRemote work
- ...primary technical leader in the northeast region with an extension into other regions... ...investigations, remedial action/mitigation measures, regulatory agency negotiations, and client or legal... ...candidate will support the leadership operations for the northeast region and nationally...OperationsRegulatoryFull timeTemporary workWork at officeLocal areaRemote workFlexible hours
$117k - $184.2k
...Analytical Research & Development (AR&D) GMP Operations, to support ELISA and cell-based... ...Assurance, Technical Operations, and CMC Regulatory Affairs, to address technical... ...technical documentation including regulatory submissions.Additional responsibilities as assigned...OperationsRegulatoryFull timeFor contractorsLocal areaVisa sponsorshipFlexible hoursAfternoon shift$117k - $184.2k
...materials for program presentations for management review and regulatory submissions, ensuring clarity and thoroughness.Lead the implementation... ...development, device development, device systems operations, quality management, or a related area.Strong knowledge of...OperationsRegulatoryFull timeFor contractorsLocal areaFlexible hours- ...Collaborate with cross functional teams to define requirements, map processes, and design solutions that align with regulatory, compliance and operational standards. Effectively collaborate with senior business and technology stakeholders, interfacing teams in...OperationsRegulatory
- ...building systems, and grounds, ensuring safety, cleanliness, and regulatory compliance. The role emphasizes collaboration with all... ...for residents, visitors, and staff. The position covers daily operations, preventive maintenance, life-safety, emergency preparedness,...OperationsRegulatory
$173.2k - $272.6k
...externalization strategy, driving a culture of scientific and operational excellence within our team and at our external... ...Leadership, People Management, Pipeline Development, Regulatory Compliance, Regulatory Submissions, Scientific Analysis, Scientific Research, Team...OperationsRegulatoryFull timeFor contractorsLocal areaFlexible hours$31.25 - $32.69 per hour
...in Elizabeth, NJ is seeking an experienced Ocean Import Coordinator to oversee end-to-end ocean import operations. You will manage shipment documentation, regulatory compliance, and coordination with internal teams to deliver exceptional service. The role requires ocean...OperationsRegulatoryHourly payFull time$142.4k - $224.1k
...Early Clinical Scientist (ECS) provides operational and scientific leadership for the... ...excellence and compliance with GCP, ICH, and regulatory requirements, supporting study... ...safety reporting, and regulatory NDA/WMA submission experience. An advanced degree is desirable...OperationsRegulatoryFull timeFor contractorsLocal areaWorldwideFlexible hours$210.4k - $331.1k
...environment.The role requires close collaboration with Clinical Operations, Regulatory Affairs, Biostatistics and Data Management, Drug Safety... ...-program planning.Experience contributing to regulatory submissions, safety reviews, or health authority interactions....OperationsRegulatoryFull timeFor contractorsLocal areaFlexible hours- ...federal Clinical Laboratory Improvement Amendments (CLIA) and operates in full compliance with all applicable regulations. Accu Reference... ...reliable test reporting. The role also involves adhering to regulatory standards and supporting continuous process improvement in...OperationsRegulatoryFull time
- ...schedule releases in coordination with development, testing, and operations teams. Manage release calendars, dependencies, and sequencing.... ...improvements. Ensure adherence to organizational policies, regulatory requirements, and industry standards. Facilitate audits related...OperationsRegulatoryLocal areaRelocation
$117k - $145k
...trial data in compliance with applicable regulatory requirements, industry standards, and... ...serves as a key liaison across Clinical Operations, Biostatistics, Medical, Safety,... ...clinical study reports, and regulatory submissions. Communicate data status, key metrics...OperationsRegulatoryInterim roleWork at officeNight shift
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