Associate Regulatory Affairs Manager - BioScience

Company: Smithfield Foods
Location: Cincinnati
Posted on: September 18, 2023

Job Description:

Your 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 Smithfield's 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. Salary Range $66,000 - $96,250 Core Responsibilities
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 .
Bachelor's 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.
Career BenefitsTo learn more about Smithfield's benefits, visit smithfieldfoods.com/careerbenefits.Why Work at Smithfield Foods? We are committed to meeting our employees' needs, addressing their concerns and helping them enjoy rewarding careers with our company. PEOPLE MATTERWith more than 60,000 jobs globally, our employees drive our success. We strive to create a fair, ethical and rewarding work environment.GROWTH & DEVELOPMENTWorking at Smithfield isn't just a job - it's the foundation for a lifelong career with training designed to help you advance professionally.BENEFITSOur people matter. That's why we offer excellent, comprehensive benefits packages to our full-time employees.SUSTAINABILITY PLEDGESustainability is ingrained in our culture and guides how we operate. We believe in innovating for the future.About Smithfield Foods Headquartered 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 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 connect with us on Facebook, Twitter, LinkedIn and Instagram. EEO/AA Information Smithfield 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.

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