Senior Regulatory Affairs Lead - Ireland MA & Compliance

Sandoz; Cork; Hybrid; EUR 60,000 - 80,000; 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 Ireland is seeking an experienced Regulatory Affairs professional to lead the preparation and submission of Marketing Authorisation dossiers and manage lifecycle activities for a portfolio of products. You will work with internal EU and local stakeholders to ensure compliance with HPRA and EU requirements, and respond to queries while monitoring regulatory changes.

The role requires a BSc in a relevant field with strong English communication skills and a track record in regulatory

Qualifications

• Bachelor-level science degree in a relevant field (Chemistry/Life Sciences) required or higher.
• Excellent written and verbal English communication skills.
• Excellent regulatory knowledge of Centralised, MRP/DCP/RUP, and IE National licensing procedures.
• Proven track record with HPRA inspections or interactions.

Responsibilities

• Prepare and submit new Marketing Authorisation applications and maintain lifecycle management for a portfolio of products.
• Collaborate with internal EU and Local stakeholders and other functions to meet objectives.
• Manage submission variations, renewals and MA transfers timely.
• Register Risk Management Plans and related materials with HPRA; ensure commitments are met.
• Respond to HPRA queries and liaise with departments and external sources for timely responses.
• Monitor regulatory changes and disseminate requirements to stakeholders in line with EU/HPRA.

Skills

Detail-Oriented

Regulatory Affairs

Education

BSc (Hons) chemistry or life sciences

MPharm (Pharmacy) desirable

Job description

Sandoz Ireland is seeking an experienced Regulatory Affairs professional to lead the preparation and submission of Marketing Authorisation dossiers and manage lifecycle activities for a portfolio of products. You will work with internal EU and local stakeholders to ensure compliance with HPRA and EU requirements, and respond to queries while monitoring regulatory changes.

The role requires a BSc in a relevant field with strong English communication skills and a track record in regulatory