Responsible for regulatory leading the compilation of all clinical/nonclinical regulatory submissions for MT1621. Directs the creation of high quality, compliant submissions within defined timelines. Will work with internal staff as well vendors to coordinate the compilation of all CTD components, ensure the clear communication of data elements in accordance with regulatory requirements, and develop/implement process to ensure all submissions are complete and will meet requirements. Will interface with other regulatory consultants/vendors on strategic and CMC regulatory submissions. May also lead to responsibility for/support of filing of New Drug Application for MT1621.
Essential Duties/ Responsibilities
- As assigned, accountable for the development and implementation of submission compilation, review, QC process to deliver high-quality submissions. This includes but is not limited to:
- define contributions for submissions (eg based on regulatory strategy plan, guidelines, gap analysis)
- communicate to functional contributors and track delivery according to agreed timeline
- Work with product development to outline and implement: 1. a timeline for all documents/submission related deliverables, 2. submission compilation process
- Delivers all regulatory milestones including assessment of any CTD content issues. In the context of NDA preparation, this would include issues that arise that could affect acceptance of the NDA and will require risk mitigation measures to be identified and implemented
- As appropriate and as assigned, participates/leads cross-functional team meetings
- Expected to share best practices, identify and communicate opportunities for enhancements and efficiencies
- Participates in and/or otherwise supports development and implementation of new or updated Regulatory systems, processes, or other relevant tools
- Partners with external vendors/consultants in support of regulatory document preparation and submission
- Is familiar and complies with relevant governing laws, regulations, and guidelines
Skills and Abilities
- PhD/PharmD with 8+ years of experience in Regulatory Affairs or BS/MS/MSN with 10+ years of experience.
- Excellent written and verbal communication skills
- Strong ability to prioritize workload, multi-task and work in a fast-paced and demanding environment
- Broad understanding of regulations and guidance
- Able to prospectively identify potential problems and to partner effectively and positively to solve issues
- True team player; comfortable with working with on and off-site team members
- Has taken part in/lead a recent (within 1-2 years) successful NDA/BLA submission to FDA
- Experience with rare disease drug development is preferred but not required.