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Job DescriptionCompany is currently expanding its Regulatory team to support multiple clinical assets and is searching for an Associate Director, Regulatory Affairs CMC. This individual will be responsible for CMC aspects, including drug substance, drug product, packaging/distribution within the Regulatory Affairs function, representing Regulatory Affairs on CMC teams and managing high-quality CMC submissions to regulatory agencies. This position reports to the Vice President, Regulatory....


Duties / ResponsibilitiesExecution of global registration strategies for all uniQure’s pipeline products and support activities in the therapeutic area of the central nervous system.Assisting in the design and analysis of Clinical Studies to support Regulatory Approvals.Review and approval of promotional, advertising, and labeling items.The preparation and submission of Clinical Trial Applications (CTAs), Investigational Medicinal Product Dossiers (IMPD), Investigational New Drug Applications....


Duties / ResponsibilitiesSupports execution of global registration and clinical development strategies for all uniQure’s pipeline products and support activities.Assisting in the global submissions for early and pivotal clinical studies to support regulatory approvals.Reviews promotional, advertising, and labeling items.Responsible for preparation/submission/maintenance of current and future MAA and IND/IMPD (including variations, amendments, annual reassessment) and Scientific Advice and FDA....

- Lexington, MA

Duties / ResponsibilitiesParticipates in the preparation of documentation packages for Regulatory submissions (including IND, CTA, BLA, etc.) to the FDA, and other Regulatory AgenciesEdits, coordinates and reviews regulatory documentation for inclusion in INDs, CTAs, BLAs, and other worldwide submissionsCompiles documentation for submissions to FDA and foreign Regulatory agenciesContributes to the further development of the Regulatory Operations infrastructure regarding documentation....


SUMMARY: The Vice President, Clinical Operations will lead all of Clinical Development Operations to achieve program objectives and ensure all successful completion of all clinical trials and related clinical trial milestones within established timelines and budgets. The Vice President will oversee the development of study protocols, clinical study execution, submissions, patient recruitment, and clinical study monitoring, clinical compliance. SOP’s, safety evaluations, preparation of....

- Cambridge, MA

Overview:This position will lead RA activities to support development and submission of materials to the FDA and other regulatory authorities, including the EU. This role will have the unique opportunity to contribute to the development of the regulatory strategy in the rapidly growing field of diagnostic next generation sequencing. This position will interact regularly with the FDA through the pre-submission and submission process.Responsibilities:Represent RA as the regulatory representative


Required SkillsPropose and design well-informed regulatory strategies for the US and EURepresent Regulatory Affairs on project subteams, especially Clinical and Nonclinical, and provide regulatory guidance to project teams (e.g., protocol reviews, report reviews, development plans)Assist in the preparation for regulatory agency meetings (e.g., Pre-IND, End-of-Phase 2, Type C, Pre-NDA/MAA/NDS)Lead the preparation of regulatory submissions including INDs, CTAs, annual reports, NDAs, MAAs,....


Job Summary Head the Quality function at Akebia. Responsible for the development, implementation, and administration of the Quality Management System (QMS) including activities, personnel, systems, procedures, and programs to provide assurance to management and stakeholders of the quality, reliability, and compliance of the organization and data outputs. Activities include management and oversight of product development, testing, stability, validation data, documentation, and records relating....


Responsibilities:Support and work in tandem with the clinical laboratory team to maintain continuous compliance with regulatory requirements.Perform routine internal audits of procedures, policies, records, and laboratory facilities. Report findings and track follow-up actions.Review batch records, reagent QC, and other process documentation.Assist in review and handling of complaints, incidents and deviations.Demonstrate strong proficiency in the application of the Corrective And Preventive....

- Cambridge, MA

Responsibilities:Assist in development and implementation of FDA compliant (QSR) Quality System; may take lead on elements of QSR implementation.Implement and maintain internal and external vendor audit program, manage approved supplier list, and lead vendor audits. Some travel required (approximately 10% annually).Provide QA oversight for materials management program and sample inspection process for all incoming materials.Provide review and feedback on validation plans and reports.Ensure....


Company is a clinical-stage pharmaceutical company focused on the discovery and development of novel first in-class drugs directed against nuclear transport targets for the treatment of cancer and other major diseases. SUMMARY: The Sr. Manager of Clinical Quality Assurance will be responsible for management of the GCP & Pharmacovigilance (GVP) Quality System in compliance with regulations so that the Quality of the company’s products is maintained, the patients’ interests are protected,....


The Director, Clinical Operations and Development will oversee clinical development of our lead program entering a Phase 3 trial in the field of neurology and CNS disorders. This key role will manage, plan, and execute clinical development programs and studies, including creating and managing study timelines, budgets, and study management plans. Additionally, s/he will provide guidance and shared learning with and across teams throughout planning and implementation, as well as ensure clinical....


Roles and Responsibilities Lead the evaluation, selection and management of Contract Research Organizations (CROs) and other external vendors to ensure successful clinical trial implementation and executionCreate, manage, and execute clinical operations and development programs, including study management, budget and timeline creationAbility to build strong KOL and Principal Investigator relationships, with the ability to easily understand and explain complex scientific topicsManage and lead a

- Cambridge, MA

Required SkillsManage the Quality Organization.Develop, implement, and administer the Quality Management System (QA Manual and other Controlled Documents, including Standard Operating Procedures, Forms, Templates, Policies, etc.). Develop, direct, and/or oversee QA activities and programs for internal and third party supplier operations that are subject to GXP regulations and guidelines; establish QA Agreements, as needed.Provide direct QA-GMP oversight of drug substance and drug product....

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