15 Specialist, US Regulatory Affairs Operations Jobs in Joseph, MO
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Specialist, US Regulatory Affairs Operations
$70k-92k (estimate)
Contractor | Pharmaceutical
2 Weeks Ago
Boehringer Ingelheim is Hiring a Specialist, US Regulatory Affairs Operations Near Joseph, MO
Location:
Hours
- Preferred: St. Joseph, MO
- Alternative: Athens, GA
- *Note requirement to be in the office 2-3 days a week.
Hours
- 20 hours per week
- 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.
- *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 BI, 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
- OR
- Associate’s degree and 3 years relevant industry experience
- OR
- In lieu of a degree, 5 years relevant industry experience including 1 year of related regulatory experience
- Health, Dental, Vision, 401k
Job Summary
JOB TYPE
Contractor
INDUSTRY
Pharmaceutical
SALARY
$70k-92k (estimate)
POST DATE
06/08/2024
EXPIRATION DATE
07/04/2024
WEBSITE
boehringer-ingelheim.com
HEADQUARTERS
RIDGEFIELD, CT
SIZE
15,000 - 50,000
FOUNDED
2009
CEO
PAUL FONTEYNE
REVENUE
$1B - $3B
INDUSTRY
Pharmaceutical
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