Global Project Regulatory Manager - UK, Remote
This is an exciting role for an experienced Regulatory Manager working with a renowned international client.
The Role
Support all the regulatory activities assigned as part of the Workstreams & Projects including, but not limited to:
- Leading and driving LCM (life-cycle management) submission activities for assigned projects/products, while applying the global strategy to submissions for changes triggered by MA Transfers, LE name changes, and Site Transfers.
- Identification of potential label issues/gaps and the development of a regulatory label negotiation strategy with contingency planning.
- Revision of label as required to achieve timely HA approval with the best possible label based on data available.
- Acting as a point of contact for the supply chain on implementation of LCM changes with both site/product divestments and long-term post-approval changes in Technical Operations.
- Providing project management capabilities to drive the execution and communication for regulatory and LCM transformation topics, e.g., sample requests, artwork updates and reference HA approvals/CPPs.
- Overseeing and finalising the timely submission of annual reports and renewals across assigned regions.
- Responsibility for appropriate entering and quality of product-specific attributes in the compliance database.
- Aligning of action trackers and communications within client RA functions and provision of oversight collaboration across the RA community by engaging with county organizations/affiliates.
- 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.
- Ensuring the preparation of timely updates to regulatory compliance systems, metadata and downstream communications.
Requirements
- At least 5 years of experience in Regulatory Affairs.
- Experience in handling manufacturing complex LCM changes both MA Transfers/Product divestments 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.
- Preferred with experience in emerging markets and international regions Strong and proven project management abilities.
- Experienced in analysing and evaluating strategies, risks and mitigations and pro-actively communicating to teams, stakeholders and escalation boards.
How to Apply
For further details, please send your CV to: talentacquisition@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.