Expiry Date: 05-12-2021
Category Regulatory Affairs
Job Type: Full Time
Windsor and Maidenhead
Regulatory Affairs, UK liaison - 12m contract - Remote
Global Biopharma Company with a substantial pipeline of products in mid to late development as well as a respectable portfolio of marketed products is seeking a RA Uk Liaison on a 12 month contract. (Remote working).
There are two aspects to this role:
The first is to be responsible for UK-specific regulatory oversight on marketed and investigational biologic and NCE products. To do this the candidate should be able to advise the development teams on local strategy and procedures. In line with this the role will serve as the primary regulatory liaison between the MHRA and the Client and will provide leadership and oversight of the transition of the MHRA through BREXIT to help ensure any impact on business continuity is minimised. In addition, the role is anticipated to include liaising with a contract organisation that provides the local affiliate regulatory resource to ensure alignment.
The second aspect, as or if time allows, is to prepare and deliver regulatory operational plans for assigned projects/products within the broader EU region. Provide strategic and operational regulatory input and guidance in cross-functional teams and manage quality regulatory submissions to agreed project targets. To achieve this the candidate must be able to work flexibly within and across regions to provide broad operational support to ensure the delivery of product team and business objectives.
2. Implementation of Plans/Compliance for the EU region:
Please do contact me ASAP if this sounds like you.
To apply for this role, please contact me, the Clinical & Medical Hiring Lead, asking for Roland Schnapka, on +44 (0)207 801 3387 or send a full CV to email@example.com. Alternatively, please press the red “Apply for position” button and follow the registration process.
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