Senior Regulatory Affairs Lead – Global Biosimilars

Sandoz; Bantry; Hybrid; EUR 70,000 - 95,000; Full time

Benefits offered by this job

Annual bonus

Pension scheme

Health insurance

24 days annual leave

Flexible working

Employee recognition scheme

Learning and development

Job summary

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.

Responsibilities

• 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.

Skills

Regulatory affairs

HPRA experience

Project delivery

English proficiency

Regulatory inspections

Education

BSc Chemistry or Life Sciences

MPharm desirable

Job description

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.