Senior Regulatory Affairs Executive

Sandoz; Bantry; Sur place; EUR 70 000 - 95 000; Plein temps

Avantages offerts par ce poste

Annual bonus

Pension scheme

Health insurance

24 days annual leave

Flexible working

Employee recognition scheme

Learning and development

Résumé du poste

Sandoz is seeking a Regulatory Affairs professional in Ireland to lead the timely preparation and submission of registration dossiers, ensuring lifecycle maintenance and full compliance with EU, HPRA, and local requirements.

You will collaborate across internal teams and external stakeholders to manage MA applications, variations and transfers while maintaining budgeted fees and ensuring readiness for inspections.

Qualifications

• Regulatory affairs expertise across Centralised, MRP/DCP/RUP and IE National licensing.
• Excellent written and verbal skills in English.
• Proven track record with the HPRA and regulatory project delivery.
• Experience with internal/external inspections is desirable.
• Strong collaboration with cross-functional teams to meet regulatory objectives.

Responsabilités

• Responsible for new MA applications and lifecycle management of a product portfolio.
• Coordinate with internal, EU and Local stakeholders for timely submissions.
• Oversee preparation and submission of MA variations, renewals and transfers.
• Register Risk Management Plans and HPRA educational material.
• Respond to HPRA licensing queries and ensure rapid, accurate responses.
• Track regulatory changes and communicate requirements to stakeholders.
• Ensure HPRA fees are paid within budget.
• Support internal audits and health authority inspections as SME.
• Close CAPAs, change controls and deviations in Regulatory Affairs.

Connaissances

Regulatory affairs

HPRA experience

Project delivery

English proficiency

Regulatory inspections

Formation

BSc Chemistry or Life Sciences

MPharm desirable

Description du poste

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!

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:

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 licensing procedures.

Proven track record of working with the HPRA.

Proven track record in the delivery of regulatory, technical and scientific projects.

Experience with internal/external inspections desirable.

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.

Why Sandoz?

Generic and Biosimilar medicines are the backbone of the global medicines industry. Sandoz, a leader in this sector, provided more than 900 million patient treatments across 100+ countries in 2024 and while we are proud of this achievement, we have an ambition to do more!

With investments in new development capabilities, production sites, new acquisitions, and partnerships, we have the opportunity to shape the future of Sandoz and help more patients gain access to low-cost, high-quality medicines, sustainably.

Our momentum is powered by an open, collaborative culture driven by our talented and ambitious colleagues, who, in return for applying their skills experience an agile and collegiate environment with impactful, flexible-hybrid careers, where diversity is welcomed and where personal growth is supported!

Commitment to Diversity & Inclusion:

We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.

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