CyberCoders Regulatory Affairs Specialist in Garland, Texas
Regulatory Affairs Specialist Regulatory Affairs Specialist - Skills Required - Regulatory Affairs, FDA Regulations, Pharmaceutical / drug manufacturing
We are a manufacturer north of Dallas due to extensive growth we are currently looking for a Regulatory Affairs Specialist to join our team!
The ideal Regulatory Affairs Specialist will have at least 3 years of experience in field, laboratory, or production facility quality control. and previous experience working in a food, nutritional supplement, drug related manufacturing environment preferred.
If you are a Regulatory Affairs Specialist with experience in a drug manufacturing environment, please read on!
What You Will Be Doing
Handle compliance with regulatory standards, systems, processes and SOP's.
Review MMR and BMR template and form.
Prepare or review/evaluate Change Control Report.
Investigate/analyze and support customer quality concerns.
Review supplier qualifications.
Evaluate supplier/vendor create SOPs as it relates to regulatory standards.
Train relevant personnel when SOPs and its related forms are changed.
Prepare new documents or suggest changes to existing documents and ensure that all new and changed documents are approved by GMP manager prior to issue.
Review labeling of existing products and new products.
Point of Contact for US FDA and State DSHS.
Apply for CFS and COO from the State DSHS.
Prepare all audits including a State Audits.
Review and approve all labels.
Review all clinical trial documents to evaluate new ingredients for the product.
What You Need for this Position
Bachelor's degree in chemistry, biology, microbiology or food science.
Two to four years of experience in field, laboratory, or production facility quality control. Previous experience working in a food, nutritional supplement, drug related manufacturing environment preferred.
Must be willing to abide by policies and procedures, including those that are safety-related
What's In It for You
We are offering an excellent environment with room for growth, base salary, benefits and bonus potential.
So, if you are a Regulatory Affairs Specialist with experience in a drug manufacturing environment, please apply today!
Applicants must be authorized to work in the U.S.
CyberCoders, Inc is proud to be an Equal Opportunity Employer
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status, or any other characteristic protected by law.
Your Right to Work – In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the United States and to complete the required employment eligibility verification document form upon hire.
Regulatory Affairs Specialist TX-Garland PD2-1473226