Regulatory Affairs Specialist
Company: Cymabay Therapeutics
Posted on: November 24, 2022
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
* Communicates and coordinates regulatory activities with other
* 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,
Job Type: Full-time%58047475%
Keywords: Cymabay Therapeutics, Newark , Regulatory Affairs Specialist, Other , Newark, California
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