15 Scanner -Sr. Regulatory Affairs Specialist Jobs in Joseph, MO
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Scanner -Sr. Regulatory Affairs Specialist
$70k-91k (estimate)
Contractor | Business Services
3 Weeks Ago
Fladger Associates is Hiring a Scanner -Sr. Regulatory Affairs Specialist Near Joseph, MO
St Joseph, MO
Contract Duration: 8-24 months
Rate: Negotiable
Salary: NA $1.00
Responsibilities
Contract Duration: 8-24 months
Rate: Negotiable
Salary: NA $1.00
Responsibilities
- Excellent employment opportunity for a Scanner - Sr. Regulatory Affairs Specialist in the St Joseph, MO area.
- Scan, compile, organize and name documents that support all regulatory activities required by Federal, State, Local, and International laws, as well as internal policies for continued manufacturing, distribution, and sales of veterinary biologics.
- In a team environment, to provide logistical and tactical regulatory expertise to internal business partners and stakeholders.
- This includes scanning, compiling, organizing and naming documents that:
- Support regulatory compliance of licensed biological products throughout their lifecycle
- Support responses to regulatory inspections and government inquiries (domestic and international)
- Provide regulatory assessments for proposed business and manufacturing changes related to approved biological products in compliance with USDA and international guidelines and regulations.
- Provide regulatory expertise and advice, as appropriate, to other functions or interdisciplinary project teams (in-line product management, launch teams, etc.).
- Maintain work instructions and tools (records, schedules, reports, database, etc.) for timely and efficient management of regulatory activities.
- Support organization, archiving, and retrieval of regulatory documents and correspondence.
- Maintain regulatory databases, activities charting, and government submission and response tracking.
- Bachelor's Degree from an accredited institution, preferably in area of Science In lieu of a Science Degree, 2 years of relevant industry experience.
- Ideal candidate would have Regulatory or quality knowledge and expertise.
- Experience in the Pharmaceutical, Biologics and/or related industries or disciplines dealing with US local, State, and Federal Regulatory issues related to in particular those associated with product development, licensure, and maintenance, licensed manufacturing facilities and related industry matters.
- Experience with Biologics product under the jurisdiction of USDA or other government agencies preferred.
- Excellent communication (verbal and written), organizational, and teamwork skills.
- Committed to performance with attention to details Innovative problem-solving skills
- Computer skills, including proficiency in Microsoft Word, Excel, Adobe Acrobat
- Required Skills: GOVERNMENT CONTRACT, COMPLIANCE REGULATIONS, REGULATORY AFFAIRS
Job Summary
JOB TYPE
Contractor
INDUSTRY
Business Services
SALARY
$70k-91k (estimate)
POST DATE
06/07/2024
EXPIRATION DATE
07/29/2024
WEBSITE
fladgerassociates.com
HEADQUARTERS
Bear, DE
SIZE
<25
INDUSTRY
Business Services
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