HomeJob Details
Return To Job List

Regulatory Affairs Specialist - Labeling III

Location: Fort Worth , Texas
Job Category:

11+ month contract
Will provide regulatory expertise to drug development teams on the development and submission of labeling components for prescription drug, over-the-counter (OTC) drug, device and biologic products to support compliance requirements for regulatory agency approval.

Responsibilities include:
Controls the consistency of labeling through review of content across the product family.
Act as Regulatory sign-off for packaging and label reviews.
Coordinate labeling review process for new product launches as well as updates to current packaging and labels.
Process draft labeling for health authority submissions.
Complete FDA drug e-listings.
Support day-to-day compliance activities (e.g. change control for packaging/labeling, distribution reports).
Draft and maintain applicable policies and procedures to support and define the regulatory affairs function.
Perform other duties as needed.

Bachelor's degree in biological or health care scientific discipline
Required Experience:
5 years of relevant experience preferred.
Equivalent combination of education, training, and relevant experience may be considered in place of the education stated above.
In-depth knowledge of the scientific principles of the drug development process.
In-depth knowledge of regulations pertaining to drug product labeling.
Excellent oral and written communication skills.
Good project management skills
Effective critical thinking skills
Excellent attention to detail

Return To Job List

Apply For This Position - Regulatory Affairs Specialist - Labeling III

*First Name:
*Last Name:
Cover Letter:
Please enter characters below and submit:

Return To Job List