Regulatory Affairs Manager

Regulatory Affairs Manager

Sandoz

Bantry, Ireland

Role Purpose

To effectively manage the Regulatory Affairs team responsible for global products to ensure:

• Timely and accurate preparation and submission of registration dossiers to obtain and launch new Irish Marketing Authorisations in collaboration with internal EU and Local stakeholders.
• Lifecycle maintenance of existing Marketing Authorisations in collaboration with internal EU and Local stakeholders.
• Oversight and reporting of department KPIs, with responsibility for the maintenance of regulatory databases and systems.
• The provision of strategic and operational regulatory support for commercial and compliance driven projects in line with business needs.
• To ensure 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:

• The management and sustained performance of the Irish Regulatory Affairs team responsible for global products (MAs granted via Centralised, MRP/DCP/RUP, and Irish National procedures).
• The continuous development of direct reports to ensure capabilities in line with regional and local functional needs, sustained team engagement, and execution of succession planning.
• Execution of business aligned regulatory filing and new product launch strategies in collaboration with regional and local stakeholders.
• Timely filing of post-authorisation regulatory submissions such as variations, Article 61(3) applications, renewals, PSURs, DSURs, risk minimisation measures, Sunset Clause notifications, safety label updates and post approval commitments.
• Assessment of CMC regulatory data requirements and development of regulatory submission strategies considering both compliance and commercial needs.
• Regulatory lead in cross functional collaboration and business partnering to ensure awareness of external customer needs, responsibilities and priorities, and effective execution of cross functional working.
• Engagement with the HPRA to address application queries, liaising with relevant company departments and external sources to ensure full and rapid responses.
• Oversight and reporting of department KPIs, with accurate maintenance of regulatory databases and systems.
• Timely gap assessment of internal Operating Procedures and external regulatory intelligence, ensuring update of local procedures and communication to affected stakeholders.
• Acting as a regulatory subject matter expert as required in internal audits and Health Authority inspections.
• Coordination and execution of regulatory activities within Sandoz Quality Management Systems, including change control, deviations, quality events, CAPAs and operating procedure maintenance.
• Input into budget development, and adherence to department spending plans and financial controls.

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.
• Past people management experience, with proven track record of people development.
• Excellent current regulatory knowledge of Centralised, MRP/DCP/RUP, and Irish National licencing procedures.
• Excellent knowledge of regulatory life cycle maintenance requirements.
• Proven track record of working with the HPRA.
• Strong analytical approach balanced with a keen eye for detail demonstrated in all document control and administration undertaken. High degree of computer literacy in the use of both scientific and other role related software applications.
• Strong communication and leadership skills with the ability to select, motivate, train and develop staff to achieve both company and personal goals.
• Proven track record in the delivery of regulatory, technical and scientific projects.
• Strategic and entrepreneurial thinker with the ability to provide a strong results focus for project teams to achieve goals and time sensitive deadlines to deliver what is needed to achieve the overall business results.
• Experience with internal/external inspections
• Excellent communication skills