Regulatory Operations Specialists - II Associate

Job Title: Regulatory Affairs Labeling Specialist

Work Location: Millsboro DE (Hybrid)

Contract Duration: 12 Months

Working Hours: 8AM 5PM Monday Friday

Note:

• Hybrid schedule (require to be onsite for 3 days/week Tuesday and Wednesday fixed) 3rd day can be discussed when on assignment.

Qualifications:

Title: Regulatory Affairs US Biologicals labeling specialist

Minimum Education: Associate degree.

Preferred Education: Bachelor/Masters degree in Life Science.

Required Experience and Skills:

• With Associate minimum 35 years of relevant experience within pharmaceutical labeling experience.
• With Bachelors minimum 03 years of relevant experience within pharmaceutical labeling experience.
• With Masters minimum 02 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:

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.

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 labeloriented 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 SOPs and FDA regulations.