Regulatory Affairs Associate - Labeling Job

REGULATORY AFFAIRS ASSOCIATE needed for a CONTRACT opportunity with Yoh's client located in Huntsville, AL

Top Skills You Should Possess:
- Regulatory Affairs
- Pharmaceutical Industry experience
- Labeling

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 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 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:
- BS degree in Life Science or related field
- Minimum of two (2) years of experience in regulatory affairs, specifically labeling
- Good writing skills, strong organizational skills; detail oriented; proficient in MS Word, Adobe Acrobat and document scanning program, printing; strong interpersonal skills and excellent working relationship for interacting with internal/external customers

WHAT ARE YOU WAITING FOR? APPLY NOW!

RECRUITER: Tonya Allen

Yoh makes finding and applying for jobs simple. Partner with Yoh to find the right opportunities across multiple industries in the US and UK. Find out more here !

Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer, M/F/D/V.

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