Immediate need for a talented Associate Regulatory Operations Specialists - II. This is a 15 months Contract opportunity with long-term potential and is located in Millsboro, DE(Onsite). Please review the job description below and contact me ASAP if you are interested.

Job ID: 24-24844

Pay Range: $23 - $27/hour. Employee benefits include, but are not limited to, health insurance (medical, dental, vision), 401(k) plan, and paid sick leave (depending on work location).

Key Responsibilities:

• 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.
• Training with the USDA regulations on packaging, ARTIS computer system and internal processes and workflows for packaging submissions and filing maintenance.
• Training Type: Corporate Development - Coaching

Key Requirements and Technology Experience:

• Bachelor/Master's degree in Life Science.
• 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/nice to have: Industry - Pharmaceutical Industry/Vaccine manufacturing/Medical and Biotechnology
• 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.

Our client is a leading Pharmaceutical industry, and we are currently interviewing to fill this and other similar contract positions. If you are interested in this position, please apply online for immediate consideration.

Pyramid Consulting, Inc. provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.