Director, Regulatory Affairs
Reporting directly to the Head of Regulatory Affairs and Quality Assurance, the Director, Regulatory Affairs will contribute to the formulation of regulatory strategy, serve as the regulatory lead on relevant project teams, and act as the regulatory contact for US/Global health authorities as required. This individual will oversee the planning and execution of major submissions and responses to regulatory authorities related to IND/NDA submissions, Annual Reports, Investigator Brochures, IND amendments, briefing documents for Health Authority meetings, as well as responses to requests. The ideal candidate will possess solid experience with Regulatory CMC to collaborate cross-functionally to help develop CMC regulatory strategy, provide guidance to broader CMC functions, and drive CMC regulatory filing(s). This individual will provide regulatory support and guidance to various cross-functional teams and ensure all applicable regulatory requirements are considered and appropriately incorporated into clinical and future commercial products.
- Responsible for coordinating all aspects of regulatory submissions relevant to assigned projects or programs
- Provide regulatory leadership and guidance to project teams
- Develop response strategies and submissions to regulators
- Develop briefing packages for meetings with FDA and other global health authorities
- Responsible for actively contributing to the development and implementation of regulatory strategy for assigned projects and programs for projects in all stages of development (IND through commercial)
- Integrate global regulatory understanding and responsibilities in developing strategy and development of regulatory submission documents
- Manage or delegate the management of the completion of documents and other assigned tasks within established timelines and with high quality – in terms of scientific content, organization, clarity, accuracy, format, consistency and adherence to regulatory guidelines, styles and processes
- Develop strategies and drafts and/or review responses and other documents intended for submission to FDA and other global health authorities
- Provide critical review of all documentation supporting regulatory applications
- Identify and assess regulatory risks for assigned projects or programs
- Prepare and deliver effective presentations for external and internal audiences
- Contact regulatory agencies relevant to assigned projects or programs, as appropriate
- Participate and contribute in Health Authority meetings as required
Education/ Skills Required:
- Bachelor of Science in a scientific discipline, advanced degree highly preferred.
- Prior pharmaceutical industry experience and a minimum of 8 years in Regulatory Affairs
- Evidence of successful submissions to FDA (e.g., NDAs, INDs, briefing packages) and demonstrated evidence of writing of regulatory documents
- Previous small molecule drug and NDA-level experience are a strong plus
- Established working knowledge of regulatory guidelines and regulations (US and international).
- Regulatory experience supporting both development projects and commercial products.
- Strong knowledge of eCTD elements and structure and regulatory writing skills.
- Experience working with all levels of management and consulting with key business stakeholders. An ability to influence for greater outcomes.
- Demonstrated ability to work well with other accomplished professionals within and across functions/teams. Willing collaborator.
- Strong communication skills both written and oral.
- Ability to multi-task and shift priorities rapidly to meet tight deadlines.
- Professional demeanor and an excellent written and verbal communicator.
- Detail oriented and well organized.
- Good and thoughtful listener.
- Enthusiastic, self-motivated and keen to improve processes and overcome inefficiencies.
- Proficient in Microsoft Office suite and applications.