What are the responsibilities and job description for the Regulatory Operations Specialist position at Careers Integrated Resources Inc?
Job Title: Regulatory Operations Specialist
Location: Millsboro, DE
Duration: 12 months
Note:
• Hybrid schedule (require to be onsite for 3 days/week -Tuesday and Wednesday fixed) 3rd day can be discussed when on assignment.
Description:
Responsibilities
Client Animal Health 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
Quals--
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 5-7 years of relevant experience within pharmaceutical labeling experience.
• With Bachelor's, minimum 4-6 years of relevant experience within pharmaceutical labeling experience.
• With Master's minimum 2-5 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.
Must have:
• 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.
Location: Millsboro, DE
Duration: 12 months
Note:
• Hybrid schedule (require to be onsite for 3 days/week -Tuesday and Wednesday fixed) 3rd day can be discussed when on assignment.
Description:
Responsibilities
Client Animal Health 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
Quals--
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 5-7 years of relevant experience within pharmaceutical labeling experience.
• With Bachelor's, minimum 4-6 years of relevant experience within pharmaceutical labeling experience.
• With Master's minimum 2-5 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.
Must have:
• 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.
