Regulatory Affairs Lead — Flexible, High-Impact Approvals

CZ04 (FCRS = CZ004) Sandoz s.r.o; Cork; Hybrid; EUR 70,000 - 95,000; Full time

Benefits offered by this job

Competitive salary

Annual bonus

Pension scheme

Health insurance

24 days annual leave

Flexible working arrangements

Employee recognition scheme

Learning and development opportunities

Job summary

Sandoz in Ireland is seeking a regulatory affairs professional to manage new Marketing Authorisation applications and lifecycle activities. You will coordinate with internal and HPRA stakeholders to ensure timely submissions and compliance with EU and local requirements.

The role requires a strong regulatory background, experience with HPRA, and excellent English communication. A hybrid working arrangement, competitive salary, and development opportunities are offered.

Qualifications

• 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.

Responsibilities

• 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.
• Maintaining 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 CAPAs, change controls and deviations assigned to Regulatory Affairs.
• Timely gap assessment of Global Operating Procedures and update of local procedures where applicable.

Skills

Regulatory affairs

HPRA experience

Regulatory submissions

English proficiency

Communication skills

Education

BSc in chemistry/Life sciences

MPharm desirable

Job description

Sandoz in Ireland is seeking a regulatory affairs professional to manage new Marketing Authorisation applications and lifecycle activities. You will coordinate with internal and HPRA stakeholders to ensure timely submissions and compliance with EU and local requirements.

The role requires a strong regulatory background, experience with HPRA, and excellent English communication. A hybrid working arrangement, competitive salary, and development opportunities are offered.