Regulatory Affairs Manager II - Pharmaceutical
Job ID: 987228 Job Type: Contract Added - a day ago
Job Description
Innova Solutions is immediately hiring for an Regulatory Operations Manager (eCTD Submissions Management).
Position Type: Full-time Contract
Duration: 12 months with possible extension
Location: 100% Remote (EST time zone)
Job Responsibilities:
- Performs eCTD submission management across Biogen'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 product lifecycle.
- The Regulatory Ops. Manager ensures submission deliverables are incorporated and visible to all stakeholders.
- Ensures handoffs and deliverables from the 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 Biogen 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 Europe.
- Experience overseeing publishing vendors preferred.
Qualified candidates should
APPLY NOW for immediate consideration! Please hit APPLY to provide the required information, and we will be back in touch as soon as possible.
Pay Range and Benefits:Pay Range: $74.00 - $78.00 per hourBenefits: Innova Solutions offers benefits (based on eligibility) that include the following: Medical & pharmacy coverage, Dental/vision insurance, 401(k), Health saving account (HSA) and Flexible spending account (FSA), Life Insurance, Pet Insurance, Short term and Long term Disability, Accident & Critical illness coverage, Pre-paid legal & ID theft protection, Sick time, and other types of paid leaves (as required by law), Employee Assistance Program (EAP).
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