Regulatory Operations Specialists at Talent Software Services
Millsboro, DE
About the Job
Regulatory Operations Specialists
Job Summary: Talent Software Services is in search of a Regulatory Operations Specialist for a contract position in Millsboro, DE. The opportunity will be one year with a strong chance for a long-term extension.
Position Summary: Animal Health is a Biotechnology Center of Excellence that manufactures, fills, packages and distributes vaccines for animals.
Primary Responsibilities/Accountabilities:
Qualifications:
Preferred:
If this job is a match for your background, we would be honored to receive your application!
Providing consulting opportunities to TALENTed people since 1987, we offer a host of opportunities including contract, contract to hire and permanent placement. Let's talk!
Job Summary: Talent Software Services is in search of a Regulatory Operations Specialist for a contract position in Millsboro, DE. The opportunity will be one year with a strong chance for a long-term extension.
Position Summary: Animal Health is a Biotechnology Center of Excellence that manufactures, fills, packages and distributes vaccines for animals.
Primary Responsibilities/Accountabilities:
- 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.
Qualifications:
- Minimum Education: Associate degree.
- 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:
- Bachelor/Master's degree in Life Science.
- Industry - Pharmaceutical Industry/Vaccine manufacturing/Medical and Biotechnology
- Attention to detail.
- 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.
If this job is a match for your background, we would be honored to receive your application!
Providing consulting opportunities to TALENTed people since 1987, we offer a host of opportunities including contract, contract to hire and permanent placement. Let's talk!
Salary
25 - 26 /hour