Associate Regulatory Affairs Manager
Company: Smithfield Foods
Location: Cincinnati
Posted on: January 27, 2023
Job Description:
Job LocationsUS-OH-CincinnatiYour OpportunitySmithfield
BioScience is part of a vertically integrated platform providing an
unparalleled level of traceability and product safety, while
offering innovative solutions to increase functionality and
viability of Smithfields non-food products for the advanced
development of pharmaceuticals, nutraceuticals, -and medical
devices.Smithfield Foods continues to invest in its BioScience unit
and is one of the only U.S. manufacturers of Heparin Sodium USP. -
Our FDA registered facility in Cincinnati manufactures drug
substances and medical device components used in cardiac surgery,
dialysis procedures, blood transfusions, device implantation, and
many other applications. As part of our Regulatory Affairs team,
you would provide technical expertise to track product from start
to finish, and develop corrective actions when needed. You will be
responsible for ensuring that we are able to safely deliver the
best Smithfield BioScience pharmaceutical product to our customers.
-This is a full-time position reporting to the Regulatory Affairs
Manager of the Company. The position is one of enhancing cGMP and
FDA regulatory compliance and assisting in the preparation and
maintenance of local, state, federal, and other geographical
regulatory filings.Visit https://www.smithfieldbioscience.com/ for
more information about Smithfield BioScience.Core
Responsibilities
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- Assist in regulatory audits (e.g. FDA, USDA, MSD). May also
assist in quality audits, if needed (e.g. internal, supplier,
customer).
- Safeguards, maintains and monitors the Company's records
pertaining to regulatory affairs
- Communicate closely with the Company's RA Manager on regulatory
compliance matters and status of short- and long-term
objectives
- Assist with dissemination of regulatory information to other
business units (e.g. QA, QC, Production, R&D) and development
of any necessary changes
- Stay up-to-date on applicable regulatory requirements that
affect the Company and its products
- Assist with the establishment of procedures based on current
regulatory best practices
- Support the preparation of regulatory filings and submission of
permit applications and renewals to local, state, federal, and
other governing bodies
- Assist with and/or prepare customer/regulatory correspondence,
such as support of customer's submission using Smithfield
BioScience product, inquiries from notified or regulatory bodies,
and attestation/declaration requests The above statements are
intended to describe the general nature and level of work being
performed by people assigned to this job. They are not intended to
be an exhaustive list of all responsibilities, duties, and skills
required of personnel so classified. May perform other duties as
assigned.QualificationsTo perform this job successfully, an
individual must be able to perform each essential duty
satisfactorily. The requirements listed below are representative of
the knowledge, skill, and/or ability required. Reasonable
accommodations may be made to enable individuals to perform the
essential functions.
- Bachelors degree from a regionally accredited four-year college
or university in science or related field and 3+ years of relevant
experience; or equivalent combination of education and
experience.
- Knowledge and understanding of quality management stems,
quality assurance principles, SPC and statistics; preferred.
- Knowledge of cGMP and FDA regulations for pharmaceutical
products.
- Experience in good record keeping practices.
- Excellent written and verbal communication skills.
- Strong attention to detail.
- Ability to manage multiple priorities in a fast-paced
environment.
- Must have the ability to complete required applicable forms in
English, which requires the ability to read and write in
English.
- Ability to work well with others in fast paced, dynamic
environment.
- Ability to be respectful, approachable and team oriented while
building strong working relationships and a positive work
environment.Supervisory Responsibilities
- Provides leadership and guidance to employees in the Quality
Assurance and Regulatory Affairs Department.
- Carries out supervisory responsibilities in accordance with the
organization's policies and applicable laws.
- Responsibilities include interviewing, hiring, and training
employees; planning, assigning, and directing work; appraising
performance; rewarding and disciplining employees; addressing
complaints and assisting in providing appropriate
resolutions.Careers and BenefitsTo learn more about Smithfields
benefits, visit -smithfieldfoods.com/careerbenefits. - - - - - - -
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- - - - - -More than 63,000 employees globally drive our success.
We strive to create a fair, ethical and rewarding work environment.
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Smithfield isn't just a job it's the foundation for a lifelong
career with training designed to help you advance professionally. -
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- - - - - - - - - - - - - - - - - - - - -Our people matter. That's
why we offer excellent, comprehensive benefits packages to our
full-time employees. - - - - - - - - - - - - - - - - - - - - - - -
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- - - - - - - - - - - - - - - -SUSTAINABILITY PLEDGE - - - - - - -
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- - - - - -Sustainability is ingrained in our culture and guides
how we operate. We believe in innovating for the future. - - - - -
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- - - - - - - - - -About Smithfield FoodsHeadquartered in
-Smithfield, Va. -since 1936, Smithfield Foods, Inc. is an American
food company with agricultural roots and a global reach. With more
than 60,000 jobs globally, we are dedicated to producing "Good
food. Responsibly" and serve as one of the world's leading
vertically integrated protein companies. We have pioneered
sustainability standards for more than two decades, including our
industry-leading commitments to become carbon negative in our U.S.
company-owned operations and reduce GHG emissions 30 percent across
our entire U.S. value chain by 2030. We believe in the power of
protein to end food insecurity and have donated hundreds of
millions of food servings to our communities. -Smithfield -boasts a
portfolio of high-quality iconic brands, such as -Smithfield,
Eckrich -and Nathan's Famous, among many others. For more
information, visit -www.smithfieldfoods.com, and connect with us on
Facebook, Twitter, LinkedIn and Instagram.EEO/AA
InformationSmithfield is an equal opportunity employer committed to
workplace diversity. All qualified applicants will receive
consideration for employment without regard to race, color,
religion, sex, sexual orientation, national origin, age, gender
identity, protected veterans status, status as a disabled
individual or any other protected group status or non-job
characteristic as directed by law.
Keywords: Smithfield Foods, Cincinnati , Associate Regulatory Affairs Manager, Executive , Cincinnati, Ohio
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