Source Job

The Regulatory Document Coordinator will have primary responsibility for document management activities supporting Regulatory Affairs. Key responsibilities include word formatting, PDF publishing, eCTD output review, submission archival, and document workflow management. This position will play an integral role in the execution of the Regulatory strategy world-wide, with multiple avenues for continued development.

Spyre Therapeutics is a clinical-stage biotechnology company pioneering long-acting antibodies and antibody combinations to redefine the standard of care

Responsible for managing the preparation, quality control, publishing, dispatch, and archival of all regulatory submissions within the Veeva RIM system. Oversees the regulatory submission process for all assigned projects and products throughout their lifecycle. Provides training and guidance to regulatory staff on Veeva RIM functionality and best practices.

Dynavax is a commercial-stage biopharmaceutical company developing and commercializing novel vaccines to help protect the world against infectious diseases.

• Assist in the production of regulatory reports.
• Review data inputs and outputs to ensure regulatory information is prepared and disclosed consistently.
• Support documentation updates and provide ad-hoc support for various regulatory tasks.

Tandem is the UK's greener digital bank on a bold quest to revolutionise the way we save, borrow, spend, and share.

• Provides regulatory guidance throughout the clinical development life cycle.
• Develops and/or reviews documents intended for submission to the Regulatory Authorities and/or Ethics Committees to assure compliance with regulatory standards.
• Serve as representative of Global Regulatory Affairs at project team meetings with both external and internal customers

Precision for Medicine integrates clinical trial execution with scientific knowledge, laboratory expertise, and data sciences, focusing on Oncology and Rare Disease. The company values employee contributions and nurtures ideas, striving for positive change.

• Ensure robust compliance across our global operations.
• Manage all aspects of regulatory reporting, ensuring accurate and timely submissions across a broad range of regulations.
• Lead effective exam management, handling regulatory requests and coordinating internal stakeholders across diverse jurisdictions.

Anchorage Digital is a crypto platform that enables institutions to participate in digital assets through custody, staking, trading, governance and the industry's security.