About this role
Role Overview
- Ensure continuous, compliant and timely regulatory submissions
- Create and manage submission content plans in conjunction with Regulatory Affairs strategy and CMC leads, cross-functional colleagues, and global vendors, from initiation through to approval and dispatch, for all Regulatory submissions (IND, IMPD, NDA, MAA, Agency Responses, others)
- Publish, validate, and transmit eCTD submissions to the gateway
- Track regulatory commitments for assigned products
- Schedule and coordinate, with contributing departments, the development of submission deliverables
- Communicate directly with functional authors to obtain submission documents in a timely manner
- Manage the publication and submission of regulatory documents in electronic common technical document (eCTD) format, and/or paper submissions, when required
- Oversee the writing, review, implementation, and continuous improvement of standards, templates, and procedures related to the publishing, review, QC, transmittal, and archiving of paper and electronic regulatory documentation
- Develop and maintain best practices, consistent with evolving FDA and international guidelines for electronic submissions
- Serve as a contact for the maintenance of electronic document management systems and publishing tool used to support regulatory submissions, identifying system issues, reaching out to the appropriate resources and stakeholders, and coming up with solutions.
Requirements
- Minimum of BS or BA in a scientific or relevant technical discipline preferred
- Experience of 7+ years pharmaceutical or biotech industry, with basic regulatory operations experience managing the creation and submission of an IND/NDA/BLA
- Experience with Microsoft Word, Adobe Acrobat, Smartsheet, electronic publishing software, and electronic document management systems required; experience with Veeva RIM, Submissions, and Archive preferred
- Current knowledge of, and experience with eCTD, including expertise with submission publishing tools (eCTD building tools); experience with publishing, validating, and submitting in full eCTD format; knowledge of publishing best practices
- Proven ability to function in a biotech start-up, fast-paced, innovative, dynamic environment while remaining flexible, proactive, and resourceful
- Ability to adhere to strict project timelines and budgets, and to advise teams and management of impacts and changes in project timelines.
Benefits
- 99% of the premium paid for medical, dental and vision plans
- Company-paid life insurance
- AD&D, disability benefits, and voluntary plans to personalize your coverage
- 401(k) matching dollar-for-dollar up to 6%
- Long-term stock incentives and ESPP
- Discretionary quarterly bonus
- Flexible wellness benefit
- Generous PTO
- Paid holidays and company-wide shutdowns