Regulatory Affairs Specialist (Fixed Term Contract)

at  Sandoz

The purpose of the role is to ensure timely, accurate and strategic preparation and submission of registration dossiers to obtain and launch new UK Marketing Authorisations whilst also supporting business needs such as re-introductions, change of ownership and portfolio expansion projects.
This is a one year fixed-term contract role with our Regulatory Team at Sandoz, UK

ESSENTIAL REQUIREMENTS:

• Bachelor’s degree in Life Sciences.
• Experience (2 to 3 years) in Regulatory Affairs within a Generic or Pharma business.
• Experience in supporting new product launch activities
• Ability to be flexible and multi-task within a fast-paced environment.
• Desirable:
• Experience in working with new product registration & CMC elements of a dossier.
• Experience in project management.
• Experience in working with various variation applications.

YOUR RESPONSIBILITIES INCLUDE, BUT NOT LIMITED TO:

• The execution of business aligned regulatory filing strategies in collaboration with regional and local stakeholders to meet the product launch deadline.
• Preparation and submission of the following:
• New Marketing authorisation application (National/IRP/ ACCESS)
• MA variation
• Change of ownership applications
• Educational materials and associated risk minimisation measures
• Timely execution of launch enabling regulatory activities such as the registration of Risk Management Plans and associated educational materials, the registration and sign off artworks, approval of launch limiting variations.
• Engagement with the MHRA to address application queries, liaising with relevant company departments and external sources to ensure full and rapid responses.
• Creation, assessment and approval of artwork texts and mock-ups.
• License cancellations.
• 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.
• Liaising with launch team to input the progress of regulatory application and/ or projects to assist with mapping out product launch activities.
• Handling the regulatory activities in relation to the re-introduction of license and coordination with other stakeholder to ensure execution of regulatory strategy in this regard.
• Handling labelling changes and associated regulatory applications (e.g. PIQ) as per business or external needs.
• Ensuring timely response to Corrective and Preventative Actions (CAPAs) assigned to DRA and other associated quality management activities.
• Working in accordance with Global and local Working Instructions, SOPs whilst adhere to compliance.
• Maintenance of regulatory archives and record keeping.
• Reviewing and updating Summaries of Product Characteristics.
• The processing and clear communication of regulatory approvals to internal and external stakeholders within set timelines.
• Provision of regulatory support for medical information and patient safety to assist with queries on product information.
• Provision of regulatory support for strategic commercial opportunities.
• Provision of regulatory support for internal and external audits.
• Carrying out other activities which contribute to the effective performance of the Regulatory Affairs Department.