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Regulatory Operations Specialists

4 months ago

De Soto, United States Experis Full time

Our client, one of the largest pharmaceutical companies in the U.S., is looking for a Regulatory Operations Specialists - II (Associate)t which is located at DeSoto, KS.

Job Title: Regulatory Operations Specialists - II (Associate)
Location: DeSoto, KS
Pay rate: $26/HR

Must have:

  • Recent grad with scientific background- are Ok to submit as long as they have excellent computer skills with ADOBE and office.
  • Regulatory labeling content review as per FDA guideline.
  • Quality check of labeling content errors.
  • Label artwork, label design review.
  • Support the preparation of labeling documents, coordinating labeling document submissions to regulatory bodies.
  • Looking for someone with labeling expertise in the pharmaceutical industry, vaccines manufacturing or GMP.
Typical day:
  • Very intensive label-oriented job
  • Need someone to hit the ground running.
  • Label review and submission of labeling documents and artwork
  • Label artwork, label design review.
  • Quality check for label content and formatting as per FDA guidelines.
  • Support the team with the review, revising labeling.
  • Attention to details.
  • Will prepare the label content following SOP’s and FDA regulations.
Qualifications:
Title: Regulatory Affairs US Biologicals labeling specialist
  • Minimum Education: Associate degree.
  • Preferred Education: Bachelor/Master's degree in Life Science.
Required Experience and Skills:
  • With Associate, minimum 3-5 years of relevant experience within pharmaceutical labeling experience.
  • With Bachelor's, minimum 0-3 years of relevant experience within pharmaceutical labeling experience.
  • With Master's minimum 0-2 year of relevant experience within pharmaceutical labeling experience.
  • Require someone with scientific background or familiarity with medical terminology.
  • Require someone with excellent proofreading skills.
  • Proficient in standard computer programs such as Microsoft Office, Excel, Word, Outlook,SharePoint, ADOBE.
Preferred/nice to have:
  • Industry - Pharmaceutical Industry/Vaccine manufacturing/Medical and Biotechnology
Personality:
  • Attention to details.
  • Team Player.
  • Able to follow directions.
  • Can work independently once the trainings are complete.
  • Able to make sure that regulations are met.
  • Excellent communication and written skills.
  • Open minded.
Responsibilities:
Our Client is a Biotechnology Center of Excellence that manufactures, fills, packages, and distributes vaccines for animals.

This position is responsible but is not limited to the following duties:
  • 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.
Training
  • Training with the USDA regulations on packaging, ARTIS computer system and internal processes and workflows for packaging submissions and filing maintenance.
  • Training Type: Corporate Development - Coaching 

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.