What are the responsibilities and job description for the Regulatory Operations Specialists position at TALENT Software Services?
Are you an experienced Regulatory Operations Specialist with a desire to excel? If so, then Talent Software Services may have the job for you! Our client is seeking an experienced Regulatory Operations Specialist to work at their company in Millsboro, DE.
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.
Salary : $25 - $26
