Job Information
US Tech Specialist, US Regulatory Affairs Operations in Alpharetta, Georgia
Duration:24 Months Contract (Possible Extension)
Shift:8 AM - 5 PM (Flexible)
Note:the requirement to be in the office 2-3 days a week.
This is a part-time role (20 Hours/Week)
The strong requirement for proficiency in MS Office applications and Adobe Acrobat
Responsibilities:
With minimum guidance, prepare high-quality US regulatory submissions required by local and federal agencies to maintain BI products on the market.
With minimum guidance and supervision prepare regulatory submissions for activities such as labeling supplements, DERs, EPA monthly and aggregate reports, drug product listing, establishment registration, advertising and promotional materials, product import, pesticide state adverse event reporting, state licensing renewals, state product renewals, and tonnage reporting.
With minimum guidance and supervision, contribute to the development and implementation of processes and work instructions.
Understand and monitor regulatory trends; understand and implement regulations and guidance. Interact with the authorities in a professional manner.
Responsive to government agencies for questions on submissions.
With minimum guidance and supervision, support systems for product compliance and maintenance.
Skills:
General knowledge in relevant Regulatory Affairs areas. General knowledge and understanding of regulatory legislation and requirements for the maintenance of veterinary products
General knowledge of the legal requirements for maintenance of veterinary medicinal products.
Maintains compliance with respect to all requirements for assigned products.
Ensures company interests are supported/maintained in negotiations with regulatory authorities resulting from requests and information received from regulatory authorities.
Proficient in standard office technology, including Word, Excel, and Adobe Acrobat.
- Strong written and verbal communication skills
Strong attention to detail
Must exhibit good judgment, and ability to problem-solve issues in daily work
Demonstrated ability to successfully collaborate in a global organization and manage a full workload.
Able to meet stringent time and quality demands.
Self-motivated with a high degree of initiative, commitment and persistence.
Well developed organizational capabilities.
Strong team player who is collaborative with the mission of BI, but able to drive change.
AI Competencies
Education:
Bachelor's degree and 1 year relevant industry experience/Associates degree and 3 years relevant industry experience
In lieu of a degree, 5 years of relevant industry experience including 1 year of related regulatory experience
About US Tech Solutions:
US Tech Solutions is a global staff augmentation firm providing a wide range of talent on-demand and total workforce solutions. To know more about US Tech Solutions, please visit www.ustechsolutions.com.
US Tech Solutions is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.