US
0 suggestions are available, use up and down arrow to navigate them
PROCESSING APPLICATION
Hold tight! We’re comparing your resume to the job requirements…
ARE YOU SURE YOU WANT TO APPLY TO THIS JOB?
Based on your Resume, it doesn't look like you meet the requirements from the employer. You can still apply if you think you’re a fit.
Job Requirements of Regulatory Affairs Associate III:
-
Employment Type:
Contractor
-
Location:
Deerfield, IL (Onsite)
Do you meet the requirements for this job?
Regulatory Affairs Associate III
Careers Integrated Resources Inc
Deerfield, IL (Onsite)
Contractor
Job Title: Regulatory Affairs Associate III
Job Location: Deerfield, IL
Job Duration: 12 Months (possibility of extension)
Payrate: $64.00/ hr on w2
Essential Duties and Responsibilities:
Job Location: Deerfield, IL
Job Duration: 12 Months (possibility of extension)
Payrate: $64.00/ hr on w2
Essential Duties and Responsibilities:
- With direction, develop and execute regulatory project plans.
- Identify and elevate key areas of regulatory risk.
- Maintain regulatory files in a format consistent with requirements and perform MoH submissions.
- Maintain awareness of regulatory requirements; identify relevant requirements.
- Participate as an active team member and provide regulatory advice to project teams as required.
- Respond to 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.
- Support regulatory activities relating to specific portfolio of products/projects.
- Prepare, review, and approve labeling and SOP’s.
- Represent or lead Regulatory Affairs in small project teams.
- Bachelor’s degree or country equivalent in a scientific discipline
- Minimum of 3 years regulatory experience in drugs within a pharmaceutical company, CRO, or similar organization.
- Experience in US/FDA regulations and submissions is required, experience in EU and/ or Rest of the world will be a plus.
- Global environment experience
- Knowledge of regulations.
- Scientific knowledge.
- Work autonomously.
- Project management skills.
- Manage multiple projects and deadlines.
- Ability to multitask and prioritize.
- Interpersonal and communication skills.
- Negotiation skills.
- Technical system skills (e.g. word processing, spreadsheets, databases, online research).
- Ability to identify compliance risks and escalate when necessary.
- (Teams/Onsite, Length, Rounds, Team involved)- Teams.
Get job alerts by email.
Sign up now!
Join Our Talent Network!