Regulatory Affairs Specialist
Company: Aston Carter
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 Bachelor 's degree in Chemistry, Pharmaceutical
Sciences or a related field. Master 's degree preferred.
- Minimum 7 years ' experience in Regulatory Affairs or similar
position that is responsible for submission of ANADA 's, 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 experience
About Aston Carter:
At Aston Carter, we 're 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
today 's 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: Aston Carter, Elgin , Regulatory Affairs Specialist, Other , Elgin, Illinois
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