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 Merck Gruppe - MSD Sharp & Dohme
- Job Description The Specialist Regional Submissions Planner will work within our Global Regulatory Affairs and Clinical Safety (... ...organization, in the Regional Regulatory Operations department (RRO), supporting... ...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
$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$80k - $120k
...corporate, commercial, transactional, regulatory, compliance and other activities. This... ...Company (including Business Development, Operations, Finance, Regulatory and Sales), along... ...coordinating renewals, tracking fees and submissions, maintaining license and permit records...OperationsRegulatoryContract workFlexible hours- ...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
- 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
- ...Patient-Reported Outcomes requirements for regulatory and reimbursement agencies.... ...of COA endpoints to support regulatory submissions, reimbursement evidence dossiers, payer... ...Biostatistics, Outcomes Research, and Operations to ensure COA endpoint strategies are consistent...OperationsRegulatoryWork experience placement
$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- ...primary technical leader in the northeast region with an extension into other regions... ...investigations, remedial action/mitigation projects, 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
$180k - $200k
...senior leadership, regulators, and a broad range of business operations. The ideal candidate will bring a strong background in financial... ...-level audit reporting, management information (MI), and regulatory requirements. Contribute to continuous improvements in audit...OperationsRegulatoryFull time- ...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
- ...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
$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
- ...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
- ...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
- ...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
- ...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
- ...federal Clinical Laboratory Improvement Amendments (CLIA) and operates in strict compliance with all applicable regulations. Accu Reference... ...ensures proper sample handling, and maintains compliance with regulatory and accreditation standards. Daily responsibilities include...OperationsRegulatoryFull timeNight 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$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$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$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$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$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- ...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
- ...clear and concise manner for review by senior compliance staff or regulatory bodies as needed. Coordinate with other departments to... ...regulations and be able to apply them effectively in day-to-day operations. Participate in regular training sessions to stay updated...OperationsRegulatoryFull time
$142.4k - $224.1k
...day-to-day data-management operations and resources within the assigned... ...quality delivery, supports regional strategy and resourcing, and... ...) processes and local regulatory requirements; drive consistent... ...outcomes, and support consistent, submission-ready outputs across studies...OperationsRegulatoryFull timeFor contractorsLocal areaFlexible hours
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