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Qualified Scientist & Principal Recruitment ConsultantHelping professionals find the next step in their career, while fulfilling top client…
Regulatory Affairs Manager - Global CMC
Co. Dublin - Hybrid
Our client is a well established GMP Pharmaceutical firm in Dublin.
Why Apply For This Role?
* Lucrative benefits including Private Healthcare, Pension, 25 Days Annual Leave PLUS Public Holidays and more.
* Vibrant work culture
* Proven progression opportunities and career trajectories internally
Key Responsibilities
* Lead the planning, preparation, and submission of high-quality CMC regulatory documentation (Module 3) for global submissions including MAAs, INDs, NDAs, BLAs, and variations/supplements.
* Develop and execute global CMC regulatory strategies that align with project objectives and timelines.
* Serve as the CMC regulatory lead on cross-functional teams and provide strategic guidance throughout the product lifecycle.
* Liaise with global regulatory agencies on CMC-related topics, including responding to questions and deficiency letters.
* Support post-approval CMC activities, including change management, renewals, and annual reports.
* Ensure CMC documentation is compliant with current regulatory guidelines (ICH, EMA, FDA, etc.) and internal quality standards.
Key Skills Required
* BSc in Scientific discipline
* 5+ years of experience in Regulatory Affairs with a focus on CMC.
* Proven track record of preparing and managing CMC submissions for drug products (small molecule or biologics).
* Strong knowledge of EU and US regulatory requirements; experience with global markets.
Seniority level
* Seniority level
Not Applicable
Employment type
* Employment type
Full-time
Job function
* Job function
Science, Manufacturing, and Research
* Industries
Pharmaceutical Manufacturing
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