Associate Regulatory Affairs Manager - Smithfield BioScience
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.
- 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.
To 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.
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.
To learn more about Smithfield’s benefits, visit smithfieldfoods.com/careerbenefits.