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&D, Quality, Manufacturing, Regulatory Operations, and regional regulatory teams.
- Participate in training, compliance activities, and continuous professional development.
Requirements:
- Mandatory hands-on CMC authoring experience (initial registrations and/or post-approval variations).
- Strong understanding of pharmaceutical development, manufacturing, and cGMP requirements.
- Working knowledge of global CMC regulations and guidelines.
- Experience collaborating with development and manufacturing teams.
- High standards of regulatory compliance, quality, and scientific integrity.
- Excellent written and verbal communication skills.
- Proficiency with Microsoft Office and document management systems.
- Ability to act as a CMC subject matter expert or trusted technical resource.
Why Apply
This role offers the opportunity to work on impactful global regulatory programs, collaborate with diverse technical teams, and contribute to improving patient access to high-quality medicines worldwide.
