Regulatory Affairs Manager II at Randstad USA

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. With a hefty goal of discovering medical breakthroughs to treat devastating neurological ailments, our partner is focused on furthering research and finding ways to improve our healthcare system. You can feel secure in the fact that you will be paving the way to life changing practices when you work for this well-known team!

 
location: Chicago, Illinois
job type: Contract
salary: $70.00 - 77.63 per hour
work hours: 9 to 5
education: No Degree Required
 
responsibilities:

• Performs eCTD submission management across Company's product portfolio to Health Authorities for global development and lifecycle management submissions.
• The Regulatory Operations Manager is responsible for the coordination of all publishing deliverables, in line with the strategic direction of their assigned programs/products. Oversee outsourced publishing deliverables on a day-to-day basis to ensure successful execution of operational activities for assigned products.
• Acts as the primary point of contact for regulatory functions as appropriate in the products lifecycle.
• The Regulatory Ops. Manager ensures submission deliverables are incorporated and visible to all stakeholders.
• Ensures hand offs and deliverables from authoring community are on time and in line with the submission standards and expectations of quality.
• Drives deliverable timelines with RSM (RA Regulatory Submission Manager) and authoring community and sets appropriate standards and expectations of quality.
• Responsible for electronic submissions and documents meeting regulatory agency and Company submission standards and technical requirements.
• Quality control checks on electronic common technical (eCTD) components, final submissions, hyperlinks and bookmarks, and ensures submissions adhere to local health authority guidelines.
• Demonstrates expert knowledge of submission or technology-related Health authority guidelines/regulations.
• Competent in the use of electronic document management and submissions publishing tools.

 
qualifications:

• 3-5 years of experience in regulatory operations providing submission delivery support for the US and Eurpoe. Experience overseeing publishing vendors preferred.

 
skills: GCP (Good Clinical Practice), Regulatory Affairs Operations, Regulatory Affairs Strategy, Regulatory Briefing Documents, Submissions

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 HRsupport@randstadusa.com.

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.