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.