Hi,
My name is Gaurav and I am a recruiter with Net2Source Inc. I saw your profile on one of the job boards and our direct client is looking to hire a Regulatory Operations Specialist - II (Associate) in their growing team.
Please find below the job description.
Job Title: Regulatory Affairs US Biologicals labeling specialist
Location: Millsboro, DE 19966 (Hybrid)
Duration: 12+ Months (Extendable)
Responsibilities
*** 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.
Quals--
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
Thanks
Gaurav Gupta
Sr. Pharma Recruiter
(201) 331-8302