15 US Regulatory Affairs Operations Specialist Jobs in Joseph, MO
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US Regulatory Affairs Operations Specialist
$70k-92k (estimate)
Full Time | Business Services
2 Weeks Ago
LanceSoft Inc is Hiring an US Regulatory Affairs Operations Specialist Near Joseph, MO
Note requirement to be in the office 2-3 days a week.Remote eligible: NoFull time or part time: Part timeShift: Anywhere between 8 am to 5 pm, Monday-Friday as scheduledHours: 20 hours per weekAny possibility of the assignment to be converted to a full-time role? Not at this timeDuties
- With minimum guidance, prepare high quality US regulatory submissions required by local and federal agencies to maintain CLIENT 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.
- Note strong requirement for proficiency in MS Office applications and Adobe Acrobat
- 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 CLIENT, but able to drive change.
- AI Competencies
- Accountability: Taking ownership for decisions and actions.
- Agility: Quickly acting with an open mind to face internal and external circumstances. Intrapreneurship: Together with our customers, internal or external, creating innovative ideas to respond to changing needs.
- Bachelor's degree and 1-year relevant industry experience
- Associate’s degree and 3 years relevant industry experience
- In lieu of a degree, 5 years relevant industry experience including 1 year of related regulatory experience
- ADOBE ACROBAT
Job Summary
JOB TYPE
Full Time
INDUSTRY
Business Services
SALARY
$70k-92k (estimate)
POST DATE
06/09/2024
EXPIRATION DATE
07/03/2024
WEBSITE
lancesoft.com
HEADQUARTERS
HERNDON, VA
SIZE
500 - 1,000
FOUNDED
2000
TYPE
Private
CEO
DIVYA GANDHI
REVENUE
$200M - $500M
INDUSTRY
Business Services
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About LanceSoft Inc
LanceSoft is a provider of application development, management outsourcing and data-warehousing services to the aerospace and automotive sectors.
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