Assistant Manager / Manager / Senior Manager – Regulatory Affairs (Global CMC) We are seeking 3 x experienced Regulatory Affairs professionals with strong Global CMC expertise to support branded pharmaceutical products across development and the commercial lifecycle.
Join this growing Hub for Reg Affairs for Europe based in Dublin North.
(Hybrid)
Responsibilities Author and coordinate CMC sections for new registrations, post-approval changes, renewals, annual reports, and line extensions.
Prepare and manage responses to regulatory authority questions and perform quality reviews of CMC submissions.
Ensure submissions meet global regulatory requirements, internal policies, and agreed timelines.
Contribute as a CMC representative on project teams, assess regulatory risk, and support global regulatory strategies.
Manage regulatory commitments, submission tracking, and CMC documentation systems.
Communicate CMC issues clearly to cross-functional stakeholders and provide scientific and technical guidance.
Build effective partnerships with R