Our client is currently seeking a full time Regulatory Affairs Manager with regulatory affairs and electronic submissions experience within the biotech and/or pharmaceutical industry. The ideal candidate must have prior experience managing an external publishing vendor, preparing electronic regulatory submissions and submission timelines. There will be opportunities to learn and contribute to regulatory strategy of development projects.
- Participates in project team meetings and provides regulatory support and guidance (with supervision) and manages day-to-day regulatory activities.
- With supervision, contribute to regulatory strategy of development projects.
- Manage the preparation of regulatory submissions by overseeing all associated deliverables and timelines, and communicate submission progress to internal stakeholders.
- Draft cover letters, FDA Form 1571, and other administrative documents for submission to FDA, as needed.
- Attend teleconferences with FDA, assist project teams in preparation of FDA meetings, and assist in drafting meeting minutes, and with supervision, assist in drafting responses to questions from FDA.
- Provide regulatory publishing support, including organizing the submission review process, reviewing for completeness and quality, accuracy, and appropriateness, and formatting for submission. Ensure that submissions are in conformance with the latest industry and health authority submission standards.
- Contributes to design and implementation efforts to maximize electronic submissions efficiency and effectiveness.
- Manage external electronic publishing vendor and its budget.
- Responsible for logging, tracking and archiving of correspondence and submissions to/from regulatory authorities and ensure that no commitment remains unduly outstanding.