My client are a global clinical pharmaceutical company headquartered in the US. They are focused on the development, approval, and commercialization of specialty products, including a line of generic dermatology products and injectable oncology products. Due to growth and success, they are currently expanding their Dublin operation and seek to hire a Senior Regulatory Affairs professional to join their team on a permanent basis.

The role:

Reporting into the Director of Regulatory Affairs, you will liaise heavily with the U.S arm of the organisation and will be responsible for:

• Drafting, preparing and reviewing regulatory documentation for EU and international dossier submissions
• Monitoring progress of registration submissions

The person:

• Degree qualified in a pharmaceutical/technical discipline
• 5 years industry experience with relevant technical experience (QA, Tech Ops, R&D, Manufacturing)
• At least 2 years RA experience
• Experience with Module 3 CMC authoring
• Experience with the electronic submission system (eCTD)
• Understanding of requirements for sterile injectables or drug device combination products desirable

The benefits:

• Competitive salary
• Bonus
• Healthcare
• Pension
• Excellent career development and learning opportunities

To find out more, email or call + 353 1 6321866 for a confidential discussion