Email Alert for
ⓘ There was an unexpected error processing your request.
Please refresh the page and try again.
If the problem persists, please contact us with your issue.
You can always manage your preferences and update your interests to ensure you receive the most relevant opportunities.
Get ready to discover your next great opportunity.
System One
Round Lake, IL, United States
Title :Regulatory Affairs Ops Specialist II Location :Round Lake, IL or Deerfield, IL Start : ASAP Duration: Contract Summary Joule has a contract opening for a Regulatory Affairs Ops Specialist II that will be responsible for the implementation of complex global regulatory strategies, obtain and maintain marketing authorizations for product(s
Job Source: System OneSystem One Holdings, LLC
Round Lake, IL, United States
Regulatory Affairs Ops Specialist II 6 month contract $30-39/hour Description: M-F 8 - 5 Remote is an option but Onsite Preferred Summary: Responsible 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 li
Job Source: System One Holdings, LLCeTeam, Inc.
Round Lake, IL, United States
Title: Regulatory Affairs Ops Specialist I Location: Round Lake, IL Hybrid - 3 days onsite, 2 remote Duration: 12 Months Pay Range: $25.00 to $30.00/hr on W2 •Managing the preparation of regulatory submissions for IND, ANDA, NDA, 510K, Clientrom, and other electronic submission types o Creating timelines for regulatory filings o Providing and maint
Job Source: eTeam, Inc.Experis
Round Lake, IL, United States
Our client, one of the largest Healthcare companies in the U.S., is looking for a Regulatory Affairs Ops Specialist II which is Round Lake, IL. As a Regulatory Specialist you will be responsible for the implementation of complex global regulatory strategies, obtain and maintain marketing authorizations for product(s) and communication of general re
Job Source: ExperisRandstad Life Sciences
Round Lake, IL, United States
Job Description Job Description We support more patients through every point of their journey, with a broad set of solutions that empowers healthcare professionals to deliver smarter, more personalized care. Together, we are transforming healthcare with bold innovations that will help us realize our shared promise to improve care for all. This ro
Job Source: Randstad Life SciencesManpowerGroup
Round Lake
Our client, one of the largest Healthcare companies in the U.S., is looking for a Regulatory Affairs Ops Specialist II which is Round Lake, IL. As a Regulatory Specialist you will be responsible for the implementation of complex global regulatory strategies, obtain and maintain marketing authorizations for product(s) and communication of general re
Job Source: ManpowerGroupRandstad US
Round Lake
regulatory affairs ops specialist ii. + round lake , illinois + posted june 14, 2024 **job details** summary + $35 - $39.40 per hour + contract + bachelor degree + category life, physical, and social science occupations + reference48309 job details job summary: As the largest staffing and recruitment agency in the world, we can commit to finding yo
Job Source: Randstad USRandstad
Round Lake, IL, United States
regulatory affairs ops specialist ii. round lake , illinois posted 5 days ago job details summary $35 - $39.40 per hour contract bachelor degree category life, physical, and social science occupations reference48309 job details job summary: As the largest staffing and recruitment agency in the world, we can commit to finding you the perfect
Job Source: RandstadRound Lake
regulatory affairs ops specialist i.
+ round lake , illinois
+ posted june 18, 2024
**job details**
summary
+ $28 - $31 per hour
+ contract
+ bachelor degree
+ category life, physical, and social science occupations
+ reference48342
job details
job summary:
As the largest staffing and recruitment agency in the world, we can commit to finding you the perfect role that gives you the opportunity to learn and grow in the life sciences arena. Utilizing a recruiter for your job search gives you access to a large network of top employers as well as detailed information about hundreds of positions. A longtime partner who prides itself on being a leader in many different practical manufacturing processes to better serve the entire population is renowned for pioneering new treatments for renal diseases, immune disorders, and more; the focus is on patient care. If you're looking to be a part of an impactful team, you won't be disappointed!
This role requires employees to be fully vaccinated against COVID-19 as a condition of employment, subject to a valid medical or religious accommodation.
location: Round Lake, Illinois
job type: Contract
salary: $28 - 31 per hour
work hours: 9 to 5
education: Bachelors
responsibilities:
+ Managing the preparation of regulatory submissions for IND, ANDA, NDA, 510K, AdProm, and other electronic submission types
+ Creating timelines for regulatory filings
+ Providing and maintain templates for authoring.
+ Overseeing authoring and reviewing of regulatory documents
+ QC submission documents
+ Contribute to the development of process improvements and procedural documents.
+ Identifying and assessing regulatory risks and risks to timelines.
+ Providing regulatory updates to the project team on different milestones.
+ Working cross functionally with project management, operations, IT and other functions.
+ Coordinate submission scheduling with regulatory publishing and ensures delivery of high-quality documents.
+ Working closely with other members of the Regulatory team and provide support to their projects as needed.
+ Maintaining archival of submissions and health authority communications in Veeva RIM system.
+ Provide regulatory representation on key meetings, including meetings with health agency.
qualifications:
+ Solid understanding and experience and interpretation of regulatory requirements, with particular emphasis on the US region.
+ Strong organization skills and the ability to track multiple timelines in parallel and manage deadlines.
+ Excellent written and verbal communication and ability to collaborate across functions.
+ Experience with Veeva Vault systems is preferred.
+ Strong team player, self-motivated and able to function independently as well as part of a team
+ Able to work on multiple projects concurrently and adapt to a continuously changing environment.
+ BA/BS in a scientific field and 2-4 years of proven experience
skills: MS-WORD, MS-EXCEL, Submissions, QC Review
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.
At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact [email protected].
Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including health, an incentive and recognition program, and 401K contribution (all benefits are based on eligibility).
This posting is open for thirty (30) days.
Email Alert for regulatory affairs ops specialist i_ jobs in Round Lake
ⓘ There was an unexpected error processing your request.
Please refresh the page and try again.
If the problem persists, please contact us with your issue.
You can always manage your preferences and update your interests to ensure you receive the most relevant opportunities.
Get ready to discover your next great opportunity.