Regulatory Affairs Associate Manager, Operations - UK, Remote
This is an exciting opportunity to play a key role in a project for our globally renowned client.
The Role
Duties include:
- Providing global expertise on requirements for electronic document management, submission planning and compilation, publishing, and management of approval information.
- Compiling and publishing regulatory submissions in accordance with current standards (National, NEES, eCTD, etc.) and processes using agreed-upon tools.
- Performing quality checking of documents and regulatory submissions to ensure compliance with submission-ready standards.
- Managing regulatory operations processes, and regional submission strategies, and supporting global submissions.
- Proactively communicating requirements and issues in order to contribute to achieving realistic timelines
- Planning and managing detailed publishing timelines; providing reporting on publishing status to key stakeholders.
- Preparing timely updates to regulatory compliance systems, metadata and downstream communications.
Requirements
- At least 2-5 years of experience in Regulatory Affairs.
- Experience in handling dossier compilation, publishing, and submission operations.
- Ability to work proactively with stakeholders and to communicate regulatory requirements and proposals.
- Preferred with experience in emerging markets and international regions.
- Project management abilities.
How to Apply
For further details, please send your CV to: talent@gandlhealth.com
G&L Healthcare Advisors is an equal opportunities employer and welcomes applicants from all sections of the community regardless of their gender, religious belief, political opinion, sexual orientation, disability, age, marital status or race.