Katalyst Healthcares and Life Sciences
Regulatory Affairs Specialist
Katalyst Healthcares and Life Sciences, Raritan, New Jersey, us, 08869
Responsibilities and Requirements:
Supporting and Validating Regulatory systems like REMS RIMS 5+ years' experience in Computer System Validation of Regulatory systems like Regulatory Information Management System, REMS, Publishing, eCTD systems used in pharmaceutical industry. Guide the project team with the right set of applicable project deliverables based on project type and category. while catering to the SDLC Application of FDA guidance s and industry standards (i.e., GAMP). Strong understanding on 21 CFR Part 11 and Risk Based Approach with the ability to guide the project teams. Possesses strong communication skills to interact with business stake holders (Technology Leader, Project Manager, Business Owner Business users SME) and interpret business rules and requirements and documents them for software development.
Supporting and Validating Regulatory systems like REMS RIMS 5+ years' experience in Computer System Validation of Regulatory systems like Regulatory Information Management System, REMS, Publishing, eCTD systems used in pharmaceutical industry. Guide the project team with the right set of applicable project deliverables based on project type and category. while catering to the SDLC Application of FDA guidance s and industry standards (i.e., GAMP). Strong understanding on 21 CFR Part 11 and Risk Based Approach with the ability to guide the project teams. Possesses strong communication skills to interact with business stake holders (Technology Leader, Project Manager, Business Owner Business users SME) and interpret business rules and requirements and documents them for software development.