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Regulatory Affairs Specialist

Company: Aerotek
Location: Elgin
Posted on: January 15, 2022

Job Description:

Actalent is hiring for a regulatory affairs specialist for an animal pharmaceutical company near the Elgin, IL area. Description:

  • Point of contact for FDA and other applicable regulatory agency communications.
  • Assists in all regulatory inspections and coordinates all regulatory responses and final review of all regulatory filings prior to submission.
  • Ensure compliance with national and international standards and legislation.
  • Identify and interpret relevant regulatory guidelines.
  • Evaluate applicable laws and regulations to determine impact on company activities.
  • Submission of new ANADA submissions, amendments and supplements
  • Coordinating the follow-up of FDA and other regulatory agency inspections to maintain GMP compliance.
  • Collaborate with Compliance department regarding all customer complaints and customer inquiries in a timely manner - daily.
  • Representing First Priority, Inc. in the Generic Animal Drug Alliance (GADA) and participate in appropriate FDA meetings.Qualifications:
    • Previous Regulatory Affairs experience in animal or human pharmaceuticals a must.
    • Minimum Bachelors degree in Chemistry, Pharmaceutical Sciences or a related field. Masters degree preferred.
    • Minimum 7 years experience in Regulatory Affairs or similar position that is responsible for submission of ANADAs, FDA regulatory requirements and handling regulatory inspections.
    • Thorough knowledge of cGMP (21CFR parts 210 and 211)
    • Compliance and FDA audit experience preferred.
    • DVM a plus
    • 1-3 years Supervisory experience, preferably in a pharmaceutical manufacturing environment.
    • Working knowledge of Quality Control standards and laboratory experience preferably in the pharmaceutical industry.
    • Provide guidance to upper management and other employees regarding Regulatory matters as necessary.Logistics:
      • Between $22-37/hr depending on experienceAbout Aston Carter: At Aston Carter, were dedicated to expanding career opportunities for the skilled professionals who power our business. Our success is driven by the talented, motivated people who join our team across a range of positions from recruiting, sales and delivery to corporate roles. As part of our team, employees have the opportunity for long-term career success, where hard work is rewarded and the potential for growth is limitless.Established in 1997, Aston Carter is a leading staffing and consulting firm, providing high-caliber talent and premium services to more than 7,000 companies across North America. Spanning four continents and more than 200 offices, we extend our clients capabilities by seeking solvers and delivering solutions to address todays workforce challenges. For organizations looking for innovative solutions shaped by critical-thinking professionals, visit Aston Carter is a company within Allegis Group, a global leader in talent solutions.The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please call 888-237-6835 or email for other accommodation options. However, if you have questions about this position, please contact the Recruiter located at the bottom of the job posting. The Recruiter is the sole point of contact for questions about this position.

Keywords: Aerotek, Elgin , Regulatory Affairs Specialist, Other , Elgin, Illinois

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