Manager | Associate Director Global Regulatory Compliance & Operations
Global Regulatory Compliance and Operations
Reporting to the Global Regulatory Compliance, Operations, and Labeling Leader, the Sr. Manager will support the configuration and maintenance of the Enterprise Document Management System for regulated documentation to ensure regulatory compliance worldwide. In collaboration with cross-functional teams, the incumbent will also assist in the compilation and quality checks of compliant regulated documentation for dispatch to global partners and health authorities. The ideal candidate will also be adept in managing project submission timelines, schedules and regulatory submission processes.
Responsibilities of this role include:
- Assist in the configuration of a fit-for-purpose Electronic Document Management System (EDMS) for the organization.
- Work with the team in developing and implementing workflows and processes, working practices, quality controls, and proper document management principles.
- Conduct routine oversight of the strategic and operational document development of regulatory records and other GxP documentation.
- Perform document management tasks for the organization including support for authoring, review, approval, transfer, archival and ancillary activities pertaining to regulated documentation.
- Ensure timely delivery of high-quality regulatory submission documents following established regulations, industry standards and internal processes, as applicable.
- Develop document management work instructions and SOPs for the regulatory group.
- Perform regulatory quality check of eTMF documentation produced and issued by partner Contract Research Organizations (CROs)
- Provide support in the development of regulatory compliance strategies in targeted areas to ensure country-specific regulations and local environments are identified and addressed.
- Directs regulatory plans by coordinating regulatory workflow, leading submission teams and tracking and managing timelines to achieve program goals.
- Technical writing and/or review of regulatory documentation and serves as a resource for other document owners regarding regulatory content.
The successful candidate will be an innovative and collaborative leader who thrives in a start-up, fast-paced and innovative type of environment with a strong track record of hands on experience with the following mix of personal and professional characteristics:
- Bachelor's degree or equivalent experience in life sciences or technology-related discipline.
- 15 years pharmaceutical industry experience.
- 10 years regulatory affairs operations experience.
- Extensive knowledge of records management, regulatory documentation, or other relevant experience.
- Direct hands-on experience with a variety of regulatory submissions from all phases of clinical development through commercialization
- 10 years of experience on Regulatory documentation applications.
- Ability to setup strategies as well as take a hands-on approach to all regulatory activities.
- Knowledge and experience with electronic document management systems, preferably Veeva RIM.
- Knowledge of pharmaceutical regulations including cGMP, GCP, GLP, ICH guidance documents and good Document Management practice.
- Knowledge and understanding of global regulatory submission formats, industry standards, guidelines, validation concepts, and records management best practices.