CMC Regulatory Sciences Specialist
- Limerick, Republic of Ireland
- Regulatory Affairs
Are you a CMC Regulatory Sciences Specialist interested in joining a team that is already leading the way in the Pharmaceutical/Biotech industry? The company are currently building Ireland's largest bulk biologics production facility in Co. Limerick. As CMC Regulatory Specialist, you will be responsible for researching all CMC aspects of clinical and/or commercial manufacturing and for summarising the information and data as outlined in regulations and guidance for CMC documents. Due to the start-up nature of the site the progression prospects are unimaginable.
Day to Day:
As CMC Regulatory Sciences Specialist you will:
- Prepare CMC documents and sections for a variety of bio-pharmaceutical regulatory submissions, product quality reviews or other documents.
- Collaborate with project teams to manage and coordinate the authoring, reviewing, and finalisation of CMC documents in accordance with submission timelines, keeping all stakeholders, including external partners, informed of progress.
- Research and utilise information from existing documents and sources to author submission documents in a uniform style and language for regulatory compliance.
- Identify project issues and contribute to development of alternate strategies - may contribute to developing CMC regulatory strategy.
- BSc in scientific discipline
- Minimum 4 years of relevant experience
As CMC Regulatory Sciences Specialist you will be working in a state of the art biologics manufacturing facility in Co. Limerick, which is soon to be the largest, in Ireland. It is a fast paced and busy environment with huge learning and progression prospects. Working closely with global counterparts will allow you to gain a wealth of international experience. This is an opportunity to join a world class team that is already leading the way in the Pharmaceutical/Biotech industry.
For immediate consideration please apply below with an up to date CV. Not sure yet? No CV ready? Give me a call for more information.
To find out more about Real please visit www.realstaffing.com
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