Regulatory Specialist

  • Glatt Air Techniques Inc.
  • Work experience
  • Production, manufacturing
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We are a leading world supplier of integrated processing solutions for customers in the area of pharmaceuticals, food processing, feeds and fine chemicals. Our products and services stand for reliability and quality worldwide. About 3,000 employees work for Glatt at more than 15 companies and offices all over the world. For our site in Ramsey, NJ (USA) we have an immediate opening for a


Job description:

  • Oversight of day to day and long-term regulatory affairs for Glatt and Nortec products.
  • Support the Quality Assurance Department by performing QA activities including investigations, batch record review and audit

Preferred skills:

  • Degree in Chemistry, Pharmacy or related discipline with 8-10 years’ experience in the Pharmaceutical Industry, including at least 5 years’ in Regulatory Affairs and Quality Assurance required. Knowledge of cGMPs and FDA guidelines required.
  • Must be well organized, detail oriented and capable of handling regulatory activities independently. Must have a solid understanding of FDA regulations.
  • Must be a team player, able to make recommendations and meet deadlines.
  • Strong computer skills are a necessity, with an ability to accurately convey information in both spoken and written form