Regulatory Operations Consultant - Newtown, PA.

The Regulatory Operations Specialist will be accountable for providing technical guidance across all aspects of regulatory operations in order to ensure generation of the highest quality regulatory submissions for the client.

https://www.indeed.com/viewjob?t=regulatory+operations+consultant&jk=dff04718410fc981&_ga=2.63605549.34278709.1543464324-1408033885.1530798869

Regulatory Publishing Specialist - Boston, MA - KatalystHLS.com

Prepare the submissions for ANDAs, amendments, supplements, annual reports to support commercial business and to be-in compliance to FDA regulations. Review CMC submission documents from regulatory perspective to meet scientific and technical requirements for acceptability and approvability by FDA. Escalate the review findings to Manager, RA for a timely resolution. Review and implement RLD Labeling updates, prepare labeling submissions, and review promotional materials and submit to the FDA for review, as necessary. Initiate change control process and coordinate with other departments to ensure timely implementation of revised labeling. Prepare, review and submit eCTD submissions and SPLs. Proactively assess all submissions for GAP analysis and summarize a report for anticipated deficiencies prior to submission to the FDA. Work cross-functionally with other sites/CMOs, project management and R&D departments.

https://www.indeed.com/viewjob?t=regulatory+publishing+specialist&jk=7c1c884792e99959&_ga=2.63605549.34278709.1543464324-1408033885.1530798869

Regulatory Affairs Associate, CMC - San Francisco, CA.

Responsible for management of CMC regulatory activities for an enzyme substitution therapy program for domestic and international regulatory affairs. To work closely with in-house CMC teams, partners, contract manufacturing organizations, and global health authorities to ensure rapid review and approval of the CMC portions of marketing applications, amendments, supplements/ variations, and other CMC-oriented filings. Expertise with biologics and/or drug/biologic/device products is strongly preferred. Responsible for obtaining and interpreting CMC regulations and guidance and providing regulatory advice to technical operations departments.

https://www.indeed.com/viewjob?t=regulatory+affairs+associate+cmc&jk=dd0e844b838c6d33&_ga=2.63605549.34278709.1543464324-1408033885.1530798869

Quality Assurance Associate, IPQA - Durham, NC.

Responsible for providing Quality Assurance oversight for Manufacturing, Packaging, Laboratory, Warehousing, Maintenance and Engineering, ensuring products and processes are in compliance with internal and external regulations and standards. Responsible for identifying deviations in the processes and ensure that all activities are cGMP compliant, identifying corrective actions, establishing path forward activities, and appropriate documentation. The In-Process Quality Assurance Associate (IPQA) will focus on initial deviation investigative phases related to manufacturing process deviation.

https://www.indeed.com/viewjob?t=quality+assurance+associate+ipqa&jk=af6b76f12558ed63&_ga=2.116959311.832455782.1542907428-1408033885.1530798869

Validation Engineer - Deerfield, IL.

This resource will serve as a primary validation contact for Equipment (Aseptic and packaging), Clean Utilities, clean-room and other related validation activities. Team Player to work with Engineering, New Product Development, Operations, and other functions with effective communication and problem solving.Job

https://www.indeed.com/viewjob?t=validation+engineer&jk=d8200c223f392d29&_ga=2.47270638.832455782.1542907428-1408033885.1530798869

Post-Market / Sustaining Quality Engineer - Exton, PA.

The Post-Market Quality Engineer (QE) will provide technical quality leadership and support for client\'s Support transition of product licenses between Client locations and implementation of new MDR/IVDR regulations. Perform batch record review for Contract Manufacturing Organization (CMO) manufactured medical devices and sWFI globally. Support global evaluation and coordination of complaint investigation activities for devices and combination products. Support deviations, CAPAs, internal / external inspections, training and notified body interactions related to transition and new regulations. Perform supplier quality related activities for devices and combination products. Support sustaining engineering activities for devices and combination products

https://www.indeed.com/viewjob?t=post+market+sustaining+quality+engineer&jk=e92454dab5bb5435&_ga=2.74009307.832455782.1542907428-1408033885.1530798869

Manufacturing Supervisor, Upstream - Bridgewater, NJ - KatalystHLS.com

Leads the floor upstream manufacturing of clinical and commercial products. Executes pre and post processing activities such as: clean of production equipment, including the operation of automated bioreactor, harvest and media prep skids. This position is accountable for executing the manufacturing processes in Contract Manufacturing Facility and/or Master Cell Banking Facility.

https://www.indeed.com/viewjob?t=manufacturing+supervisor+upstream&jk=b7ab28155db23da3&_ga=2.47270638.832455782.1542907428-1408033885.1530798869

Submission Publisher - Foster City, CA. www.KatalystHLS.com

Experience in global eCTD filing. Reviewing the publishing request and processing as per provided comments and regulatory requirements. Processing PDF document using publishing plug-ins (Smart desk/ISI tool box or any other tool). eCTD publishing for low/medium complexity in one or more ICH region. IND and NDA eCTD submissions. Submission publishing includes creating navigation in PDF document Clinical study report, CRF processing, word formatting and publishing of eCTD, NeeS and Paper. Experience with mainstream publishing tools (e.g. Insight publisher or DocuBridge or eCTDXpress)

https://www.indeed.com/viewjob?t=submission+publisher&jk=2e41e38064c66e4c&_ga=2.13725182.832455782.1542907428-1408033885.1530798869

Process Development Specialist II - Waltham, MA.

Complete assigned activities relating to design/interpretation of scientific experiments in downstream process development Works directly with other scientists, analytical staff, and quality groups internally to assure completion of delegated tasks that provided results are on-time, documented, technically sound and robust. Performs in-process analytical instrument measurements of e.g. pH, conductivity, protein concentration by spectroscopic methods, SDS-PAGE. Develop effective relationships with scientific and operations staff to understand lab needs. Maintain the downstream lab using the 5S organization methodology by using appropriate equipment safety signage, labeling of parts/supplies use/location. Collaborates within team and department in order to follow best practices for lab operations.

https://www.indeed.com/viewjob?t=process+development+specialist+ii&jk=430cbadcad10bf0d&_ga=2.14117374.832455782.1542907428-1408033885.1530798869

Validation Engineer, Pharma Systems - Morristown, NJ.

Ensure satisfactory completion of assigned validation projects encompassing Could IT Infrastructure, equipment, instruments, cleaning, and process areas for the entire validation life-cycle. Lead the project team to fulfill the validation requirements. Develop and execute SOPs and protocols (IQ/OQ/PQ). Write associated summary reports. Ensure compliance with the Change Control system for validated state.

https://www.indeed.com/viewjob?t=validation+engineer+pharma+systems&jk=1a76c2aaae1a6124&_ga=2.9412732.832455782.1542907428-1408033885.1530798869

Clinical Data Manager, Senior - Boston, MA - KatalystHLS.com

Responsible for vendor oversight activities across global development programs. Represents data management function on the Clinical Sub-team ensuring aligned expectations between the CRO and Client for all data related deliverables, especially in support of key decision points and regulatory submissions. Contributes influential leadership in collaboration with other Client Stakeholders to ensure established milestones and deliverables are met with the highest degree of quality.

https://www.indeed.com/viewjob?t=clinical+data+manager+senior&jk=fe61887f7ecbce4b&_ga=2.14788095.832455782.1542907428-1408033885.1530798869

Regulatory Documentation Associate - Boston, MA.

Primary responsibilities include coordinating documentation for worldwide regulatory submissions; report level publishing, eCTD hyperlinking and QC checks, oversight and /or technical support of nonclinical document preparation including electronic submissions.

https://www.indeed.com/viewjob?t=regulatory+documentation+associate&jk=49a8aba824a76f4e&_ga=2.42995180.832455782.1542907428-1408033885.1530798869

Clinical Data Assistant - Boston, MA - KatalystHLS.com

Assists or develops data management plan components for study design and database content development. Responsible for eCRF testing, edit check development and configuration, documentation, and user training prior to going live. Develops and implements data management requirements within a study. Develops case report forms (CRF\'s), including validations and data collection processes.

https://www.indeed.com/viewjob?t=clinical+data+assistant&jk=78f997b3ce3a6e19&_ga=2.116998479.832455782.1542907428-1408033885.1530798869

Senior Quality Specialist - III - Princeton, NJ.

Responsible for ensuring that all Client Therapeutic Protein and Biological products managed by BQOEM are manufactured, packaged, analyzed, released stored and distributed in accordance with Client expectations and all applicable regulatory requirements. Ensures the Quality performance of external parties/partners through direct oversight, support and counselling to the partner\'s Quality unit.

https://www.indeed.com/viewjob?t=senior+quality+specialist+iii&jk=37dd0ed24b579bdd&_ga=2.48777967.832455782.1542907428-1408033885.1530798869

Regulatory Affairs Manager - Lexington, MA.

Develop regulatory submission strategies in agreement with defined product development objectives. Serve as the principal regulatory affairs liaison to FDA and other health authorities for assigned device projects. Prepare and submit device content for IND and NDA applications, or author 510K, and CE Mark regulatory filings.

https://www.indeed.com/viewjob?t=regulatory+affairs+manager&jk=94276ad24a06348c&_ga=2.111152845.832455782.1542907428-1408033885.1530798869