Animal Regulatory Affairs Associate
Sioux Falls, SD
Full Time
Experienced
The Animal Regulatory Affairs Associate is responsible for assisting with all animal regulatory activities for maintaining full compliance with all laws, regulations, and contractual responsibilities related to all projects that include the use of animals. This position requires knowledge and experience in compliance with animal care and use laws/regulations, knowledge/background in the biological sciences, as well as strong organizational, management, and interpersonal skills. This position also requires familiarity with a variety of the field’s concepts, best practices, and procedures.
Responsibilities:
Administration of SAB’s Institutional Animal Care and Use Committee (IACUC) in conjunction with the committee chairperson and ensuring the highest standards of compliance with the Animal Welfare Act and Regulations, the Public Health Service (PHS) Policy on Humane Care and Use of Laboratory Animals, the Guide for the Care and Use of Laboratory Animals, the Guide for the Care and Use of Agricultural Animals in Research and Teaching, and any other applicable guidelines or requirements.
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.
Language Skills:
Must have strong oral and written communication skills. The ability to write in-depth technical reports that require knowledge in the biological sciences with detailed structure, procedures, and outcomes is critical. Must be proficient in Microsoft Office software (Word, Excel, PowerPoint, and Outlook). Ability to effectively present information in one-on-one and group settings.
Mathematical Skills:
Utilize established mathematical and scientific techniques to compile and analyze data and put together effective and accurate reports.
Physical Demands:
While performing the duties of this job, the employee is regularly required to walk, stand, and sit. The employee will be able to use a computer for long periods at any given time. The employee must regularly lift and/or move up to 10 pounds.
Working Environment:
Normal office working conditions with periodic time spent in lab and pharm environments during inspections and at other times, per business requirements.
ADA: The employer will make reasonable accommodations in compliance with the Americans with Disabilities Act of 1990.
SAB Bio is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. SAB Bio is committed to the principle of equal employment opportunity for all employees and does not discriminate based on race, religion, color, sex, gender identify, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status or any other legally protected status. EOE/AA/Vets
Responsibilities:
Administration of SAB’s Institutional Animal Care and Use Committee (IACUC) in conjunction with the committee chairperson and ensuring the highest standards of compliance with the Animal Welfare Act and Regulations, the Public Health Service (PHS) Policy on Humane Care and Use of Laboratory Animals, the Guide for the Care and Use of Laboratory Animals, the Guide for the Care and Use of Agricultural Animals in Research and Teaching, and any other applicable guidelines or requirements.
- General IACUC responsibilities include coordination of semiannual meetings and inspections, maintaining records and documentation in a well-organized and easily retrievable manner (paper and digital), effectively communicating with committee members, facilitating protocol submission, review, and approval, and filing reports as required.
- Working directly with the United States Department of Agriculture Animal and Plant Health Inspection Service (USDA APHIS) to facilitate inspections, file required reports, and maintain compliance.
- Coordination of IACUC oversight of animal care and use at subsidiary company SAB Capra.
- Maintenance of accreditation with AAALAC International.
- Administration of SAB’s Institutional Biosafety Committee (IBC) in conjunction with the committee chairperson, Employee Health and Safety, laboratory management, and animal care management, ensuring compliance with the NIH Office of Science Policy (OSP) NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (NIH Guidelines).
- General IBC responsibilities include coordination of semiannual meetings and inspections, maintaining records and documentation in a well-organized and easily retrievable manner (paper and digital), effectively communicating with committee members, facilitating protocol submission, review, and approval, and filing reports as required.
- Assist with ensuring company-wide compliance with the biosafety program for personnel safety including the use of biological agents and recombinant nucleic acids, and physical containment requirements for research involving genetically altered animals.
- Working directly with NIH OSP to fulfill all IBC reporting requirements and maintain compliance.
- Interaction with the Food and Drug Administration’s Center for Veterinary Medicine (FDA CVM) with regards to ongoing submission of a New Animal Drug Application (NADA) for review and approval. This will include coordinating meetings, preparation of data and submission materials pre-approval, and all required post-approval reporting.
- Procure, maintain, and ensure compliance with permits for transportation of and export/import of animal products and organisms/vectors both interstate and internationally as required by USDA APHIS.
- Other responsibilities include editing and finalizing official IACUC, IBC, and FDA CVM documents to meet SAB requirements, obtaining signatures as needed (paper and digital), and uploading final PDF copies to the company intranet or elsewhere. This position may also assist the Quality Assurance (QA) department with various responsibilities as needed.
- Bachelor’s degree in biology or another relevant field required.
- 3-5 years of experience in animal regulatory and biopharmaceutical development preferred.
- General understanding of animal care and use programs and pharmaceutical industry activities and development processes also preferred.
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.
Language Skills:
Must have strong oral and written communication skills. The ability to write in-depth technical reports that require knowledge in the biological sciences with detailed structure, procedures, and outcomes is critical. Must be proficient in Microsoft Office software (Word, Excel, PowerPoint, and Outlook). Ability to effectively present information in one-on-one and group settings.
Mathematical Skills:
Utilize established mathematical and scientific techniques to compile and analyze data and put together effective and accurate reports.
Physical Demands:
While performing the duties of this job, the employee is regularly required to walk, stand, and sit. The employee will be able to use a computer for long periods at any given time. The employee must regularly lift and/or move up to 10 pounds.
Working Environment:
Normal office working conditions with periodic time spent in lab and pharm environments during inspections and at other times, per business requirements.
ADA: The employer will make reasonable accommodations in compliance with the Americans with Disabilities Act of 1990.
SAB Bio is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. SAB Bio is committed to the principle of equal employment opportunity for all employees and does not discriminate based on race, religion, color, sex, gender identify, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status or any other legally protected status. EOE/AA/Vets
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