Senior Regulatory Affairs Executive

Senior Regulatory Affairs Executive

Sandoz

Bantry, Ireland

Job Description

The purpose of the role is:

• Timely and accurate preparation and submission of registration dossiers to obtain and launch new Ireland 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, HPRA, Sandoz global and local requirements.

Your Key Responsibilities:

Your responsibilities include, but not limited to:

• Responsible for new MA applications and lifecycle management of a portfolio of products authorised via Centralised, MRP/DCP/RUP, and Irish National procedures.
• Effective team working with other business functions to achieve company objectives.
• Oversight of preparation and timely submission of new Marketing Authorisation applications, variations, renewals, and MA Transfers.
• Registration of Risk Management Plans and associated educational materials with the HPRA, with cross functional working to ensure all commitments are met and implementation is appropriately recorded.
• Responding to application or licensing queries raised by the HPRA. Liaising with relevant company departments and external sources to ensure full and rapid responses.
• Maining oversight of regulatory changes and dissemination of implementation requirements to internal and external stakeholders in accordance with EU and HPRA requirements.
• Ensuring payment of HPRA 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), change controls and deviations assigned to Regulatory Affairs.
• Timely gap assessment of Global Operating Procedures and update of local procedures where applicable.

What you’ll bring to the role:

Essential Requirements:

• BSc (Hons) chemistry or life sciences (upper second class or higher) required. MPharm (Pharmacy) highly desirable.
• Excellent written and verbal skills in English
• Excellent current regulatory knowledge of Centralised, MRP/DCP/RUP, and IE National licencing procedures.
• Proven track record of working with the HPRA.
• Strong communication skills.
• Proven track record in the delivery of regulatory, technical and scientific projects.
• Experience with internal/external inspections desirable.