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The Manager Regulatory Affairs will be responsible for the following: Leading the preparation and filing of regulatory applications (IND, NDA, BLA).Coordinating/meeting with various functional areas in order to identify and obtain information required for regulatory submissions.Developing and/or reviewing regulatory documents (IND, NDA, BLA) in order to ensure that all submissions are of high quality.Leading the preparation of responses to questions from Regulatory Authorities.Developing and....


Specialty Pharmaceutical company is expanding the Somerset, NJ location- Looking for a Supervisor, QA Documentation This position serves as a dedicated resource for the administration of controlled documentation and documentation systems at the companys Somerset site. Associated documentation, systems and activities provide support for all facets of material, process and product development, validation, manufacture, testing, storage, service and distribution. It also applies to controlled....

- Palo Alto, CA

The Director is primarily accountable for nonclinical toxicology, working in collaboration with nonclinical pharmacology and pharmacokinetic scientists to drive the overall global nonclinical regulatory submission strategy and coordination for multiple company portfolio products, from research to registration and beyond. The individual has experience in evaluating and responding to inquiries from regulatory authorities addressing global nonclinical development issues in support of IND and....

101-103 of 103 results