Regulatory Affairs Specialist (Labeling) Job

REGULATORY AFFAIRS SPECIALIST - LABELING needed for a CONTRACT opportunity with Yoh's client located in Huntsville, AL.

TOP SKILLS YOU SHOULD POSSESS:

- Labeling
- Regulatory submission documentation
- MS Word and Adobe Acrobat

WHAT YOU'LL BE DOING:

- Mark up the labeling (container and insert labels) and communicate the changes to the labeling vendor.
- Proof read the labeling for accuracy and formatting upon receipt from the vendor.
- Process the final labeling for approval and transmit the approved labeling to the vendor and internally to other groups like QA etc.
- File the approved labeling per company's procedures and policies.
- Prepare the draft labeling and coordinate with the labeling vendors to revise the labeling as directed by the supervisor
- Proofs read the labeling upon receipt from the labeling vendor for accuracy, formatting and process the final labeling for review and approval internally within the company and communicate the approvals to vendors.
- Responsible to organize and file labeling files/folders (both electronic and paper based) as per company's procedures and policies.
- Maintain the log and status reports of labeling activities
- Prepare side by side comparison of proposed labeling against current approved labeling for submission to the FDA

WHAT YOU NEED TO BRING TO THE TABLE:

- Bachelor's Degree in related field
- Three (3) years of experience in the field or in a related area with hands on in labeling
- Knowledgeable with the FDA regulations or regulatory submission

WHAT'S IN IT FOR YOU?

- This is your chance to work for a company that cares about your development and helps lead you to where you want to be

RECRUITER: Dei Blanco

Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer, M/F/D/V. Click here to contact us if you are an individual with a disability and require accommodation in the application process.

J2W: CLINICAL

MONJOB

J2WNEHLTH

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SFSF: LS