Regulatory Affairs Manager

Sandoz

Ireland
Competitive salary; annual bonus; pension scheme, ...
Management of irish regulatory affairs team
Expertise in centralised and mrp/dcp/rup procedures
Proven track record working with hpra
The role involves managing the Irish Regulatory Affairs team to ensure timely submission of registration dossiers for global products

Job Summary

  • The role involves managing the Irish Regulatory Affairs team to ensure timely submission of registration dossiers for global products.
  • Candidates must possess excellent knowledge of Centralised, MRP/DCP/RUP, and Irish National licencing procedures alongside a proven track record with the HPRA.
  • The company offers a competitive salary, annual bonus, pension scheme, health insurance, and flexible working arrangements.

Matching Summary

The role involves managing the Irish Regulatory Affairs team to ensure timely submission of registration dossiers for global products.

Salary

Competitive salary; Annual bonus; Pension scheme, Health insurance, 24 days annual leave

Skills & Requirements

Must-have

  • Management of Irish Regulatory Affairs team
  • Expertise in Centralised and MRP/DCP/RUP procedures
  • Proven track record working with HPRA
  • Lifecycle maintenance of Marketing Authorisations
  • Strategic regulatory filing and launch strategies

Nice-to-have

  • MPharm (Pharmacy) qualification
  • Experience with internal and external inspections
  • Strong analytical approach with attention to detail
  • Entrepreneurial thinking for project delivery

Key Requirements

  • BSc (Hons) chemistry or life sciences (upper second class)
  • Past people management experience
  • Excellent current regulatory knowledge of Irish procedures

Work Rights

Not specified

Tailored Resume

Cover Letter