Regulatory Affairs Manager II
12 Month Contract | REMOTE
Join a leading biopharma company supporting critical regulatory systems initiatives. We're seeking a detail-oriented consultant with expertise in Regulatory Systems, eCTD submission management, and experience working with global IT and cross-functional teams to drive system implementation and Quality Control Process, Documentation & Testing.
Key Focus Areas: Regulatory Systems Expertise | eCTD Submission | Management Global Collaboration with IT & Regulatory Stakeholders | Quality Control Processes Documentation & Testing
MUST HAVE:
- Regulatory Operations & Regulatory Systems & submission process experience
- Strong tool knowledge: Veeva, InSight, Docubridge, CARA, etc.
- Process documentation, SOPs, SOWs, workflow mapping, UAT testing
- Experience supporting system implementation and end-user training
- Solid understanding of HA regulations related to submissions and regulatory technologies
location: Chicago, Illinois
job type: Contract
salary: $60.00 - 64.12 per hour
work hours: 9 to 5
education: No Degree Required
responsibilities:
- Performs eCTD submission management across Biogen's product portfolio to Health Authorities for global development and lifecycle management submissions.
- Oversee outsourced publishing deliverables 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.
- 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.
- Competent in the use of electronic document management and submissions publishing tools.
qualifications:
- 3-5 years of experience in regulatory operations with experience in Regulatory systems and submissions.
- Regulatory Systems experience (ie, InSight, Veeva, Docubridge, CARA) and submissions process knowledge is essential.
- Experience with drafting and review of process documents, mapping, SOW documentation, and UAT testing.
- Experience of working closely with global IT and cross functional stakeholders to implement training and support to end users for new systems, tools and applications.
- Demonstrates expert knowledge of submission or technology-related Health authority guidelines/regulations.
skills: GCP (Good Clinical Practice), Regulatory Affairs Operations, 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.
It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
