- Merck & Co. (San Diego, CA)
- …Regulatory Affairs Europe (RAE) and local affiliate teams.Provide final regulatory review and approval of:Worldwide marketing applicationsClinical study ... Affairs on internal committees (eg, DRC, ADT/PDT, EDT, LEAD) to provide strategic regulatory input and approvals.Conduct initial content review and approval for… more
- Insmed Incorporated (San Diego, CA)
- …solving and issue resolution, etc.Develop risk mitigation plans for key partnersProvide regulatory review of documentation prepared by other technical functions ... Women™, Best Workplaces for Millennials™, and Best Medium Workplaces™ lists.OverviewThe Director, Regulatory Affairs will serve as the regulatory leader on… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …of Regulatory Advertising and Promotion (RAAP) will lead and oversee all regulatory activities related to the review , approval, and compliance of advertising ... resolve regulatory challenges that arise in alliance partner collaborations. Review and Approval of Promotional Materials: Review and approve advertising and… more
- Merck & Co. (Rahway, NJ)
- …for the assigned projects.- Prepare materials for program presentations for management review and regulatory submissions, ensuring clarity and thoroughness. Lead ... within Device Development and with external suppliers. Understand and apply regulatory / compliance requirements relative to design controls and risk management… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …supported areas by dedicatedly driving compliance.Ensure readiness of records for regulatory inspections and internal audits. Review , compile, and organize batch ... the team responsible for QA oversight of final CAR-T product batch record review and release practices.Lead the establishment and improvement of QA practices to… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …manner and documented in accordance with all cGMP, company policies, and appropriate regulatory standards.Performs work review , approval and close out of work ... (CMMS)Quality Management knowledge, including Change control, Deviation, and CAPA's.EHS and regulatory standards (eg EPA, OSHA and DEA)Candidate to have experience… more
- Aequor (South San Francisco, CA)
- Job Title: Senior Taxonomist - Content Review & Management Location: Onsite - South San Francisco (SSF) or Remote Contract Type: 6-Month Contract (with potential ... We are seeking an experienced and strategic Senior Taxonomist to support our Content Review and Management team. This is a 6-month contract role with the possibility… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …change controls, and maintain permanent inspection readiness and actively support regulatory inspections.Lead facility operating review meetings and sponsor ... and develop talent. Ability to create an engaged workforce.GMP Compliance & Regulatory Knowledge: Deep understanding of FDA, EMA, and other global regulatory… more
- Merck & Co. (Rahway, NJ)
- …as well as preparing for, management and follow up of regulatory inspections.Operational Quality Management:The Clinical Quality Operations Manager is accountable ... therapy area will collectively and periodically (eg quarterly) perform a TA-level review of quality plans and risk mitigation approaches in order to identify… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Quality organization at senior levels. The Director plays a pivotal role in regulatory inspections, external audits, and high impact projects, fostering s culture of ... compliance with GCP, GPV, GPEP, Data Protection, and other local regulatory requirements throughout the planning and execution of Interventional, Non-Interventional,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and programs.- Promotes Risk Based approaches to data cleaning and review - Proactively collaborates cross-functionally during interactions with Regulatory ... he/she will possess advanced knowledge of clinical operations and relevant regulatory requirements. The individual will have advanced experience working on Phase… more
- Genmab (NJ)
- …a fit? Then we would love to have you join us!The Global Regulatory Labeling, Policy and Intelligence Associate Director will primarily be responsible for leading ... portfolio of products. The lead may also be responsible for supporting various regulatory policy and/or intelligence deliverables. This role will be within Global … more
- Genmab (NJ)
- …methodologies that may support innovation and improve efficienciesEngage with regulatory authorities on compound/indication level discussionsActs as a role ... analyses requiring advanced statistical methodologies/techniquesRepresent the CDT/the company at regulatory meetings, during Key Opinion Leaders meetings, network and/or… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …of obligations deriving from these contracts. Organize and conduct periodic review of contract quality and adherence PV Regulatory Intelligence:Contribute ... language in associated contractual templates. Ensures Good Pharmacovigilance Practice and regulatory compliance in such arrangements. Contribute to the management of… more
- Merck & Co. (Durham, NC)
- …Global Vaccine Technology (GVTE), Automation, and Quality approvers.-Perform a thorough review of design & engineering records and related Good Manufacturing ... in a timely manner, and implementing corrective actions to improve the execution/ review process for equipment.Develop training material. Working as a subject matter… more
- Genmab (NJ)
- …methodologies that may support innovation and improve efficienciesEngage with regulatory authorities on compound/indication level discussionsActs as a role ... requiring advanced statistical methodologies/techniques Represent the CDT/the company at regulatory meetings, during Key Opinion Leaders meetings, network and/or… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …the Global Product Team in collaboration with Clinical Development, Regulatory , Project Management, Biostatistics, Pharmacology, and other departments to ... compound/product including project-specific training and coaching of team members and review of team output cross-functionally.Effectively represent the CSPV on the… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …member of the Technical Operations team, responsible for ensuring adherence to regulatory requirements and internal quality standards across cell and gene therapy ... continuous improvement.The Compliance Auditor will conduct internal audits, support regulatory inspections, and lead investigations to ensure process integrity and… more
- Lundbeck (Bothell, WA)
- …capacity, manage outsourced cell line development activities, author relevant regulatory sections, collaboratively support cell culture development to optimize ... amino acid analyzer.Share responsibility for equipment maintenance and upkeep. Review DNA sequencing data (including NGS), Southern/Northern blots, quantitative PCR… more
- Merck & Co. (Durham, NC)
- …the production floor, coordination across processing suites, real-time batch record review , execution of aseptic processing requirements as needed, adherence to Good ... Responsibilities include, but are not limited to :- Executes operational review and comment resolution of batch records to include binder assembly.Maintains… more
Related Job Searches:
Associate Regulatory Review,
Associate Regulatory Review Multiple,
Business Line Regulatory Review,
Regulatory,
Regulatory Review Analyst,
Regulatory Review Compliance Inspector,
Regulatory Review Compliance Medical,
Review,
Senior Associate Regulatory Review,
Senior Manager Regulatory Review