Regulatory Affairs Specialist-Submissions Job in Lake Bluff 60064, Illinois US
Regulatory Affairs Specialist-Pharmaceutical Submissions.
Contract role with possiblity of extension. No relocation assistance provided but willing to review out-of-state candidates. Bachelors degree is a strong requirement, but will consider years of regulatory document submission, registration and compliance experience within pharmaceutical or medical devices industry.
This position will be a high-level contributor in a very active pharamceutical Regulatory Affairs dept.
Looking for individual with solid experience having dealt with the registration and document submissions processes associated with FDA and affiliate compliance. Understanding of IND, NDA, ANDA, SNDA and related submissions is necessary. Registration and amendment knowledge required.
Ability to review documents for compliance, grammatical errors, standard and specs, and label-related properties, is required, This project is a large one, very urgent, handling the change control/request process involving the name change of a company division. Very detail oriented role.
Knowledge/experience in science, medical, clinical field must be demonstrated.
Resumes with the following keys expressed or detailed are most likely to be considered:
-FDA knowledge/experience
-Document submissions/registrations of pharma/med device products
-Science background and/or degree
-5 + years in FDA related environment
-NDA, IND, GCP knowledge
-Pharma, science or research regulatory affairs and quality.
-Labeling, regulatory editing, regulatory standards and specs
-Bachelors degree