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Nicon Moers

Sr. RA Manager

I have a BSc in Organic Chemistry and have more than 24 years of experience in the Pharmaceutical industry. For 16 years I worked within R&D at an API manufacturer (operating under cGMP) where I led development teams working on scale up activities for new API's such as pilot scale productions and batch validations. In my previous role I was involved in multiple harmonization projects after acquisition and a merger to one of the world's top 5 pharmaceutical companies with over 40 billion annual sales. Over the years I got specialized in setting up submission strategies for CMC variations (in large, complex projects), following up on HA questions, change control and compliance. My specialism is the regulatory strategy and execution of this strategy for API changes world-wide. I am fluent in Dutch and English. What I appreciate in STARoDub is the opportunity to work in a team with colleagues with different backgrounds and specialties. This team has broad experience and is capable of executing a big variety of projects.

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