Regulatory Affairs Manager

Job Description Summary

Join us, help us make healthcare fairer and faster.  

Job Description

Sandoz continues to go through an exciting and transformative period as a global leader and pioneering provider of sustainable Biosimilar and Generic medicines. As we continue down this new and ambitious path, unique opportunities will present themselves, both professionally and personally. Join us, the future is ours to shape!

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

You’ll receive:

Competitive salary, Annual bonus, Pension scheme, Health insurance, 24 days annual leave, Flexible working arrangements, Employee recognition scheme, learning and development opportunities.

Skills Desired

Cross-Functional Teams, Detail-Oriented, Problem Solving Skills, Regulatory Compliance