Regulatory Affairs Specialist
Posted on: January 15, 2022
Actalent is hiring for a regulatory affairs specialist for an
animal pharmaceutical company near the Elgin, IL area.
- Point of contact for FDA and other applicable regulatory agency
- 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
- Identify and interpret relevant regulatory guidelines.
- Evaluate applicable laws and regulations to determine impact on
- Submission of new ANADA submissions, amendments and
- 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
- 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
Keywords: Aerotek, Elgin , Regulatory Affairs Specialist, Other , Elgin, Illinois
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