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Associate Director, Regulatory Operations
2 weeks ago
**Adaptimmune is a fully integrated cell therapy company, designed and built from the ground up with four U.K. and U.S.based biotechnology hub locations. Our comprehensive capabilities and teams include preclinical research, clinical development, translational sciences, autologous and allogeneic manufacturing, and in-house commercial and corporate operations.**
**Our company culture is rooted in trust, inclusion, our capacity to collaborate, and our commitment to being honest and brave in our desire to successfully transform the lives of people with cancer.**
**PRIMARY RESPONSIBILITY**
This role will lead the Regulatory Operations activities within Global Regulatory Affairs. This role is accountable for managing regulatory submission related activities, providing business ownership and management of IT systems within the scope of Regulatory Affairs, and supporting development of Regulatory Operations procedures and practices. The Associate Director of Regulatory Operations is responsible for the assembly, publishing, QC, submission, and archiving of regulatory filings to global Health Authorities (HA) in an efficient and timely manner.
**KEY RESPONSIBILITIES**
- Collaborate with the regulatory team, and cross-functional team members and external contractors/vendors/consultants as needed, to support the planning, preparation, formatting, publishing, QC, submission and archiving of global regulatory submissions (i.e., INDs/CTAs/BLAs and amendments/supplements, responses to health authority requests for information, health authority briefing documents, etc).
- Provide project management support in generation of timelines for Regulatory interactions and submissions
- Organize, archive, and track Health Authority correspondences, submissions, and questions/commitments
- Collaborate with our external publishing vendor(s) on submission publishing activities to assure on time regulatory submissions in accordance with project goals and timelines. Managing the projected regulatory submissions spreadsheet and assuring alignment of resources and timelines with the external publishing vendor
- Provide business ownership of the IT systems within the scope of Regulatory Operations, such as Veeva RIM, submission publishing, CTIS, EUDAMED, and others as necessary
- Be responsible for the development, implementation, and ongoing training to the organization on Regulatory Operations processes and systems, including but not limited to changes to existing processes or systems, the introduction of new processes and/or systems, and the training of new employees as necessary. In addition, be responsible for the oversight of user access management to Regulatory systems.
- Partner with IT on the change management, release management, and ongoing validation of all Regulatory Operation computer systems
- Build the Regulatory Operations infrastructure and oversee development of standard operating procedures, training materials, and job aids with respect to Regulatory Affairs and Operations
- Coordinate collaboration with responsible departments and oversee preparation, review, and collection of documentation for regulatory submissions
- Maintaining templates and style guides for regulatory submissions and providing internal regulatory document preparation technical support
- Support the creation and monitoring of functional KPIs
**QUALIFICATIONS & EXPERIENCE**
**_Required_**
- BA/BA degree required
- 6-8+ years experience in the pharmaceutical/biotech industry, with a minimum of 5 years of Regulatory Operations and eCTD/submission publishing experience
- Thorough understanding of ICH/US/EMA regulations and guidelines related to regulatory submissions and standards.
- Experience with implementing / maintaining / utilizing a RIM system. Experience in Business or System Administrator is a plus
- Experience with managing vendors/consultants/partners (e.g. external publishing vendor)
- Strong understanding of Regulatory Operation comprehensive role
**_ Desirable_**
- Prior regulatory operations experience in cell and gene therapy and/or oncology is strongly preferred
- Experience with BLAs/NDAs/MAAs preferred
- Expertise in Veeva RIM, system implementation experience a plus
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