Beschreibung
New opportunity has been opened for a buys team in a global pharmaceutical company to support regulatory affairs projects in LCM and post marketing stage.The role is permanent and can be based in the UK or Belgium.
Your tasks:
- Prepare and deliver regulatory operational plans for assigned projects/products within a specific region as agreed with the Regulatory Scientist Lead / Manager.
- Provide strategic and operational regulatory input and guidance in cross-functional teams. Manage quality regulatory submissions to agreed project targets.
- Work flexibly within and across regions (EU, MENA…) to provide broad operational support to ensure the delivery of product team and business objectives.
- Assist in development of regulatory standards and SOPs / Workshops
- Support the Global Regulatory Scientist Lead for the delivery of timely approvals and product information in keeping with the needs identified by the business and markets and in compliance with relevant procedures and regional/local country regulations.
- Respect the planning, coordinate preparation and delivery of both simple and complex submissions throughout the product's life cycle from either a global and/or regional perspective.
- Liaise proactively with the functions and participate as a member of cross-functional delivery teams for complex submissions, providing regulatory advice
- Identify potential regulatory risks to the operational plan and propose options to mitigate risks.
- Provide regulatory expertise on regulatory submissions, health authority briefing documents and response documents
- Assume assigned responsibilities for routine and non-routine contact with health authorities and affiliates to support the Global Regulatory Scientist Lead.
- Delivers project assignments supporting the business e.g. representation on functional workstreams
- Ensure that appropriate, up-to-date records are maintained for compliance
- Assist in development of regulatory standards and SOPs
Requirements:
Scientific degree
Prior experience managing MMA dossier for global projects through CP,
Experience with Global authorities (EMEA, etc)
Strategies development
Scientific mind and approach to review documents
Cross functional experience
Please send your CV
Michael Bailey International is acting as an Employment Agency in relation to this vacancy.