Regulatory Operations Specialists - II (Associate) from Innova Solutions

Innova Solutions is immediately hiring for a Regulatory Affairs US Biologicals labeling specialist
Job Type: Full Time, Contract
Duration: 16+ months contract
Location: De Soto, Kansas ( Hybrid schedule (require to be onsite for 3 days/week -Tuesday and Wednesday fixed) 3rd day can be discussed when on assignment)

As a Regulatory Affairs US Biologicals labeling specialist your responsibilities:
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.
• 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
  
  Qualifications:
  Title: Regulatory Affairs US Biologicals Labeling Specialist
  
  Minimum Education: Associate degree.
  Preferred Education: Bachelor/Master's degree in Life Science.
  
  Required Experience and Skills:
• 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 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.
  
  Qualified candidates should APPLY NOW for immediate consideration! Please hit APPLY to provide the required information, and we will be back in touch as soon as possible.
  We are currently interviewing to fill this and other similar positions. If this role is not a fit for you, we do offer a referral bonus program for referrals that we successfully place with our clients, subject to program guidelines. ASK ME HOW.
  Thank you!
  
  Shakir Ahmed
  Sr. Recruiter
  PHONE (208-620-3493)
  EMAIL ()
  
  PAY RANGE AND BENEFITS:
  Pay Range*: Pay Range: $24 - $26 per hour.
  *Pay range offered to a successful candidate will be based on several factors, including the candidate's education, work experience, work location, specific job duties, certifications, etc.
  
  Benefits: Innova Solutions offers benefits( based on eligibility) that include the following: Medical & pharmacy coverage, Dental/vision insurance, 401(k), Health saving account (HSA) and Flexible spending account (FSA), Life Insurance, Pet Insurance, Short term and Long term Disability, Accident & Critical illness coverage, Pre-paid legal & ID theft protection, Sick time, and other types of paid leaves (as required by law), Employee Assistance Program (EAP).
  
  ABOUT INNOVA SOLUTIONS: Founded in 1998 and headquartered in Atlanta, Georgia, Innova Solutions employs approximately 50,000 professionals worldwide and reports an annual revenue approaching $3 Billion. Through our global delivery centers across North America, Asia, and Europe, we deliver strategic technology and business transformation solutions to our clients, enabling them to operate as leaders within their fields.
  
  Recent Recognitions:
  • One of Largest IT Consulting Staffing firms in the USA - Recognized as #4 by Staffing Industry Analysts (SIA 2022)
  • ClearlyRated® Client Diamond Award Winner (2020)
  • One of the Largest Certified MBE Companies in the NMSDC Network (2022)
  • Advanced Tier Services partner with AWS and Gold with MS
  
  Website: https://www.innovasolutions.com/
  
  Innova Solutions is an Equal Opportunity Employer and prohibits any kind of unlawful discrimination and harassment. Innova Solutions is committed to the principle of equal employment opportunity for all employees and to providing employees with a work environment free of discrimination and harassment on the basis of race, color, religion or belief, national origin, citizenship, social or ethnic origin, sex, age, physical or mental disability, veteran status, marital status, domestic partner status, sexual orientation, or any other status protected by the statutes, rules, and regulations in the locations where it operates. If you are an individual with a disability and need a reasonable accommodation to assist with your job search or application for employment, please contact us at or (770) 493-5588. Please indicate the specifics of the assistance needed. Innova Solutions encourages all interested and qualified candidates to apply for employment opportunities. Innova Solutions (HireGenics/Volt) does not discriminate against applicants based on citizenship status, immigration status, or national origin, in accordance with 8 U.S.C. § 1324b.
  
  The company will consider for employment qualified applicants with arrest and conviction records in a manner that complies with the San Francisco Fair Chance Ordinance, the Los Angeles Fair Chance Initiative for Hiring Ordinance, and other applicable laws.

American Cybersystems, Inc is acting as an Employment Agency in relation to this vacancy.