CMC Senior Manager - UK, Remote
Contract: Contract role
Closing Date: 31/03/23Apply Now
An excellent opportunity to join one of our exciting projects with a globally renowned client.
Supporting all the regulatory activities assigned as part of the Workstreams & Projects including, but not limited to:
- Leading and driving all global CMC submission activities (planning, authoring, reviewing, coordination, submission) for assigned projects/products, while applying the global strategy to submissions.
- Identifying the required documentation and any content, quality and/or timeliness issues for global submissions and negotiate the delivery of approved technical source documents in accordance with project timelines
- Acting as regulatory project lead and/or potentially acting as a science lead/writer as required.
- Leading and/or supporting the preparation of (module 3) CMC submissions, e.g. (planning, authoring, reviewing, coordination, submission) for assigned projects/products, while applying the global strategy into submissions.
- Authoring and/or reviewing high-quality CMC documentation for Health Authority submissions, establishing and applying CMC global strategies, current trends and guidelines.
- Aligning action trackers and communications within client RA functions and providing oversight collaboration across the RA community by engaging with county organizations/affiliates.
- Supporting and driving team discussions and preparation of CMC regulatory strategies, risks and key issues for supply limiting variations, combining variations, and implementation related decisions.
- Aligning with the current CMC 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 5 years of experience in Regulatory Affairs.
- CMC Experience in handling manufacturing site transfers, batch scale changes, and establishing comparability is preferred.
- Ability to work proactively with stakeholders and to communicate regulatory requirements and proposals.
- Experience in emerging markets and international regions preferred.
- Strong and proven project management abilities.
- Experience in analysing and evaluating strategies, risks and mitigations and proactively communicating with teams, stakeholders and escalation boards.
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.