Regulatory Operations Manager
100% Remote | EST Hours
12 Month Contract
- 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
- Regulatory Operations Experience within Pharma/Biotech
- 3-5 years of Submission Delivery Support experience
- Experience with managing publishing vendors
- US and European regulatory knowledge
location: Telecommute
job type: Contract
salary: $50.00 - 64.12 per hour
work hours: 9 to 5
education: Bachelors
responsibilities:
- The Regulatory Ops. Manager acts as the primary point of contact for regulatory functions as appropriate in the products lifecycle and 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:
- 5 years of experience in regulatory operations
- Experience providing submission delivery support for the US and Europe
- Experience overseeing publishing vendors
skills: Vendor Management, Regulatory Affairs Operations, ICH Regulations, Briefing Documents for Regulatory Agencies, FDA Submissions, Electronic Common Technical Document (eCTD)
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: medical, prescription, dental, vision, AD&D, and life insurance offerings, short-term disability, and a 401K plan (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.
