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Quality - ExM Regulatory Compliance Manager ExM Regulatory Compliance Manager

Company: Mindlance
Location: New Brunswick
Posted on: November 20, 2022

Job Description:

Job DescriptionJob Description: This role is an 18 month opportunity to gain experience with Bulk Drug Substance manufacturing working in an external manufacturing environment within a Virtual Plant Team (VPT). The ExM Regulatory Compliance manager will provide regulatory compliance support to the VPT. Reporting to the Senior Manager, Regulatory Compliance, the Regulatory Compliance Manager is responsible for all regulatory support activities within External Manufacturing to ensure that the manufacture of products by Contract Manufacturing Organizations (CMOs) is aligned with the appropriate regulatory dossiers Manage Operations Manage appropriate business processes to support Regulatory Dossier Management for products supported by External Manufacturing Manage the notification of Change Control approvals and regulatory renewals to CMOs as appropriate, to ensure that the CMO has the most up-to-date regulatory dossiers Manage a process to ensure appropriate batch restrictions are applied in the case of change controls where regulatory approvals are required Manage regulatory documentation requests to support filings, updates, annual reports renewals and Health Authority (HA) requests. Review relevant Chemistry, Manufacturing and Controls (CMC) sections of new drug applications (NDAs) and market authorisation applications (MAAs) and provide support for filings Provide Good Manufacturing Practice (GMP) and Regulatory training as required Support Regulatory inspections of External Manufacturing Manage the follow-up and close out of regulatory actions associated with External Manufacturing (ExM) Change ControlsEssential In addition to the core corporate competencies, the Regulatory Compliance Manager will have following competencies: In-depth understanding of the International Regulatory Requirements post-approval Business Knowledge/understanding of External Manufacturing. Leadership and Management Skills Excellent communication skills Understanding of current Good Manufacturing Practice (cGMP) principles pertaining to Active Pharmaceutical Ingredients (API) and Drug Product pharmaceutical manufacture Demonstrates expert knowledge of Food and Drug Administration (FDA), International Council of Harmonisation (ICH) and corporate cGMP policies and guidelines bility to manage cross functional projects and meet tight timelines/deadlines Strong Technical writing ability Openness to change, receptive to new ideas BSc / MSc in chemistry or related disciplines Preferable to have 5 years experience in Quality Assurance (QA) and 2 years in a regulatory environment. Knowledge / appreciation of other site operations such as Quality Control (QC), Materials, Manufacturing Technology (MT) and manufacturing Additional Job Requirements: None

Keywords: Mindlance, New Brunswick , Quality - ExM Regulatory Compliance Manager ExM Regulatory Compliance Manager, Executive , New Brunswick, New Jersey

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