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Regulatory Operations Specialists

1 month ago

Millsboro, United States Experis Full time

Job Title: Regulatory Operations Specialists - II (Associate)

Location: 29160 INTERVET LANE, Millsboro, DE 19966 - Hybrid

Pay Range: $23 - $26/hr

Job Description:

  • Regulatory labelling content review as per FDA guideline.
  • Quality check of labelling content errors.
  • Label artwork, label design review.
  • Support the preparation of labelling documents, coordinating labelling document submissions to regulatory bodies.
  • Looking for someone with labelling expertise in the pharmaceutical industry, vaccines manufacturing or GMP.
Responsibilities:
  • Prepare new/revised label packaging for regulatory submissions to the USDA and maintain regulatory documents to ensure site compliance.
  • Support regulatory filing submissions with the USDA for both domestic and international product packaging.
  • Independently work with internal stakeholders, regulated packaging processes and system workflows to revise or draft new packaging for vaccine biologicals for both US (domestic) and international markets.
  • Ensure prompt availability of labels and artworks and liaises with departments such as Marketing, Pharmacovigilance and Technical Services to ensure compliance with established regulations.


Best Regards,
 

If this is a role that interests you and you’d like to learn more, click apply now and a recruiter will be in touch with you to discuss this great opportunity. We look forward to speaking with you

 

About ManpowerGroup, Parent Company of:  Manpower, Experis, Talent Solutions, and Jefferson Wells

ManpowerGroup® (NYSE: MAN), the leading global workforce solutions company, helps organizations transform in a fast-changing world of work by sourcing, assessing, developing, and managing the talent that enables them to win. We develop innovative solutions for hundreds of thousands of organizations every year, providing them with skilled talent while finding meaningful, sustainable employment for millions of people across a wide range of industries and skills. Our expert family of brands – Manpower, Experis, Talent Solutions, and Jefferson Wells – creates substantial value for candidates and clients across more than 75 countries and territories and has done so for over 70 years. We are recognized consistently for our diversity - as a best place to work for Women, Inclusion, Equality and Disability and in 2022 ManpowerGroup was named one of the World's Most Ethical Companies for the 13th year - all confirming our position as the brand of choice for in-demand talent.

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