Associate Director, Regulatory Operations - Abingdon, United Kingdom - Adaptimmune

Adaptimmune

Verified Company

Abingdon, United Kingdom

2 weeks ago

Posted by:

Tom O´Connor

beBee Recruiter

Description

Adaptimmune is a fully integrated cell therapy company, designed and built from the ground up with four U.K. and 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 crossfunctional 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
68+ 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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