Regulatory Affairs Associate Manager, Lifecycle Management - UK, Remote
Contract: Contract role
Closing Date: 31/03/23Apply Now
A fantastic opportunity for a Lifecycle Management expert to join an exciting new project with our globally renowned client.
Supporting all the regulatory activities assigned as part of the Workstreams & Projects including, but not limited to:
- Supporting and coordinating sample requests.
- Making project updates and communicating routinely to downstream country organizations.
- Supporting requests for artwork, mock-ups, and labelling as triggered by MA Transfers, LE name changes, and Site Transfers Initiate.
- Consolidating and tracking all CPP requests for countries to drive on-time submission strategies in the regions.
- Acting as a point of contact for the supply chain on the implementation of LCM changes with both site/product divestments and long-term post-approval changes in Technical Operations.
- Aligning action trackers and communications within client RA functions and providing oversight collaboration across the RA community by engaging with county organizations/affiliates.
- Responsibility for the finalization and timely submission of annual reports and renewals across assigned regions.
- Responsibility for the appropriate entering and quality of product-specific attributes in the compliance database.
- Supporting team discussions and the preparation of regulatory strategies, risks and key issues for supply limiting variations, combining variations, and implementation-related decisions.
- Aligning with the current RA lead and responsible team about any ongoing dossier updates in order to coordinate regulatory actions on the same brand and ensure proper project updates.
- Preparing timely updates to regulatory compliance systems, metadata and downstream communications.
- At least 2-5 years of experience in Regulatory Affairs.
- Experience in handling manufacturing LCM changes both license transfers and those driven by technical changes such as site transfers and separation activities.
- Ability to work proactively with stakeholders and to communicate regulatory requirements and proposals.
- Experience in emerging markets and international regions preferred.
- Project management abilities.
How to Apply
For further details, please send your CV to: email@example.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.