14 USA - Regulatory Affairs Ops Specialist II- Kronos Jobs in Round Lake, IL
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USA - Regulatory Affairs Ops Specialist II- Kronos
$73k-96k (estimate)
Contractor | IT Outsourcing & Consulting
2 Weeks Ago
eTeam is Hiring an USA - Regulatory Affairs Ops Specialist II- Kronos Near Round Lake, IL
Title: Regulatory Affairs Ops Specialist II
Location: Round Lake, IL (Hybrid)
Duration: 6 Months
Pay Range: $35.00 to $40.00/hr on W2SummaryResponsible for the implementation of complex global regulatory strategies, obtain and maintain marketing authorizations for product(s) and communication of general regulatory requirements in support of licensing of Clients products. Serves as a consultant to managers. Manage regulatory activities relating to specific global portfolio of products/projects.
Essential Duties And ResponsibilitiesThis section contains a list of five to eight primary responsibilities of the work. The incumbent will perform other duties as assigned.
" Initiate and develop complex regulatory project plans
" Identify & prioritize key areas of regulatory risk
" Monitor applicable regulatory requirements
" Create and maintain regulatory files in a format consistent with requirements
" Provide regulatory advice to project teams.
" Respond to complex questions from regulatory authorities within strict timelines
" Compile and submit, in a timely manner, regulatory documents according to regulatory requirements
" Maintain and update existing regulatory authorizations
" Manage regulatory activities relating to specific portfolio of products/projects
" Prepare, review, and approve labeling and SOPs
" Lead or represent Regulatory Affairs in project teams
" Provide guidance and coaching for areas of responsibility to lower level team members
QualificationsTo perform this job successfully, an individual must be able to perform each essential duty satisfactorily. List knowledge, skills, and/or abilities required.
0 N/A: Intern or Co-op
"
" Knowledge of regulations
" Scientific knowledge
" Project management skills
" Manage multiple projects and deadlines
" Ability to multitask and prioritize
" Interpersonal and communication skills
" Strong negotiation skills
" Technical system skills (e.g. word processing, spreadsheets, databases, online research)
" Ability to work effectively in multinational/multicultural environment
" Ability to identify compliance risks and escalate when necessary
Education And/or ExperienceInclude the education and/or experience that is necessary to perform the job satisfactorily.
0 N/A: Intern or Co-op
Bachelors degree or country equivalent in a scientific discipline
Minimum of 5 years regulatory experience within a pharmaceutical company for medicinal products, CRO, or similar organization. FDA regulations and knowledge
Location: Round Lake, IL (Hybrid)
Duration: 6 Months
Pay Range: $35.00 to $40.00/hr on W2SummaryResponsible for the implementation of complex global regulatory strategies, obtain and maintain marketing authorizations for product(s) and communication of general regulatory requirements in support of licensing of Clients products. Serves as a consultant to managers. Manage regulatory activities relating to specific global portfolio of products/projects.
Essential Duties And ResponsibilitiesThis section contains a list of five to eight primary responsibilities of the work. The incumbent will perform other duties as assigned.
" Initiate and develop complex regulatory project plans
" Identify & prioritize key areas of regulatory risk
" Monitor applicable regulatory requirements
" Create and maintain regulatory files in a format consistent with requirements
" Provide regulatory advice to project teams.
" Respond to complex questions from regulatory authorities within strict timelines
" Compile and submit, in a timely manner, regulatory documents according to regulatory requirements
" Maintain and update existing regulatory authorizations
" Manage regulatory activities relating to specific portfolio of products/projects
" Prepare, review, and approve labeling and SOPs
" Lead or represent Regulatory Affairs in project teams
" Provide guidance and coaching for areas of responsibility to lower level team members
QualificationsTo perform this job successfully, an individual must be able to perform each essential duty satisfactorily. List knowledge, skills, and/or abilities required.
0 N/A: Intern or Co-op
"
" Knowledge of regulations
" Scientific knowledge
" Project management skills
" Manage multiple projects and deadlines
" Ability to multitask and prioritize
" Interpersonal and communication skills
" Strong negotiation skills
" Technical system skills (e.g. word processing, spreadsheets, databases, online research)
" Ability to work effectively in multinational/multicultural environment
" Ability to identify compliance risks and escalate when necessary
Education And/or ExperienceInclude the education and/or experience that is necessary to perform the job satisfactorily.
0 N/A: Intern or Co-op
Bachelors degree or country equivalent in a scientific discipline
Minimum of 5 years regulatory experience within a pharmaceutical company for medicinal products, CRO, or similar organization. FDA regulations and knowledge
Job Summary
JOB TYPE
Contractor
INDUSTRY
IT Outsourcing & Consulting
SALARY
$73k-96k (estimate)
POST DATE
06/15/2024
EXPIRATION DATE
07/14/2024
WEBSITE
eteaminc.com
HEADQUARTERS
SOUTH PLAINFIELD, NJ
SIZE
500 - 1,000
FOUNDED
1999
TYPE
Private
CEO
BIPIN TAHKUR
REVENUE
$50M - $200M
INDUSTRY
IT Outsourcing & Consulting
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About eTeam
eTeam provides industry-specific, SOW-based services, and global contingent workforce managementsolutions.
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