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Regulatory Affairs Specialist

Company: Cymabay Therapeutics
Location: Newark
Posted on: November 24, 2022

Job Description:

*Summary: *
The Regulatory Affairs Specialist reports to the Vice President of Regulatory Affairs. The Associate Regulatory Affairs role is an entry level regulatory position that provides varying levels of product support to the: (1) regulatory Chemistry, Manufacturing and Controls (CMC), (2) regulatory clinical and (3) regulatory operations. Support may include organizing, managing, and executing on regulatory CMC, clinical and operations projects in support of regulatory submissions. Tasks may include formatting of documents per style guide, searching for and organizing data from regulatory repository systems, drafting meeting agendas and minutes, managing document reviews, and other tasks as requested.

Essential Functions and Job Responsibilities: *

* Maintains regulatory files / submissions.
* Provides submission support for regulatory filings.
* Project plan regulatory submissions including identifying key stakeholders, deliverables, milestones and dependencies to ensure timely project completion.
* Provides support for regulatory documentation, as required.
* Maintains submission logs / generates reports, as necessary.
* Maintains FDA registrations and License renewals, as required.
* Communicates and coordinates regulatory activities with other departments.
* Generate Standard Operating Procedures (SOP's) as needed for the Regulatory Affairs group.
* Remain cognizant of important developments in FDA and other regulatory agencies that may impact product line.
* Contribute towards improving company processes and procedures while continuing to ensure compliance with applicable regulations and relevant standards.

*Minimum Qualifications: *

* BA/BS or equivalent education with 1-3 years of relevant experience in Regulatory Affair
* Knowledgeable of GCP requirements and FDA guidelines
* Demonstrates strategic thinking skills, and has the ability to drive projects based on group objectives
* Excellent writing and organizational skills, and an ability to generate clear, concise documents
* Strong planning and organizational skills.
* Solid understanding of desktop application software suites, especially Excel


Job Type: Full-time%58047475%

Keywords: Cymabay Therapeutics, Newark , Regulatory Affairs Specialist, Other , Newark, California

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