Regulatory Affairs Manager - Sandoz UK

Aug 27, 2021
United Kingdom

Job Description

500 million+ – this is the number of patients treated with a Sandoz medicine globally. A division of Novartis, Sandoz is a global leader in generic and biosimilar medicines is looking for a Regulatory Affairs Manager.

This exciting role will effectively manage the Drug Regulatory Affairs (DRA) team responsible for global products and act as Deputy Head, in the absence of department head.

Your responsibilities:
Your responsibilities include, but are not limited to:
• Timely and accurate preparation and submission of registration dossiers to obtain and launch new UK Marketing Authorisations in collaboration with internal EU and Local stakeholders.
• Lifecycle maintenance of existing Marketing Authorisations in collaboration with internal EU and Local stakeholders.
• Continued compliance with all relevant legislation, guidelines, and practices, including EU, MHRA, Sandoz global and local requirements.
• Coaching and development of their team to ensure they are suitably equipped and trained to perform their tasks effectively.
• Registration of Risk Management Plans and associated educational materials with the MHRA, with cross functional working to ensure all commitments are met and implementation is recorded.
• Liaising with customers and third-party suppliers concerning regulatory activities such as own label supplier registration, ongoing maintenance, and change of ownerships, to ensure compliance is maintained whilst meeting customer expectations.
• Responding to application or licensing queries raised by the MHRA.
• Maintaining oversight of regulatory changes and dissemination of implementation requirements to internal and external stakeholders in accordance with MHRA requirements.
• Maintaining a current awareness of regulatory requirements for the marketing of medicinal products in the UK and general legislation and guidelines relating to medicinal products in the EU.
• Ensuring payment of MHRA fees within the departmental budget.
• Acting as a regulatory subject matter expert as required in internal audits and Health Authority inspections.
• Ensuring timely close out of Corrective and Preventative Actions (CAPAs) assigned to DRA.
• Timely gap assessment of Global Operating Procedures and update of local procedures where applicable.

Minimum Requirements

United Kingdom
Frimley / Camberley
Research & Development
Full Time

Regulatory Affairs Manager - Sandoz UK

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