Director, Regulatory Affairs

The Director of US Regulatory Affairs must be able to assess the project from a regulatory standpoint using a broad understanding of the FDA requirements and be able to prepare and maintain US submissions for all pharma& products. The Director must be able to develop and implement the US regulatory strategy. This employee will be the pharma& liaison with the FDA, as well as business partners. The Director develops departmental US budgets, US schedules, and performance metrics and ensures that all requirements are met. This role is very much “hands on” position as it will be the point person for all current US Regulatory Affairs.Job Responsibilities:Key responsibilities may include the following:Be the subject matter expert in all aspects of US Regulatory Affairs and represent Regulatory Affairs on all related workstreams and in joint alliances as required. Additionally, this role will be responsible for being primary FDA contact for assigned projects.Responsible for preparing and submitting all the required submissions to FDA in support of NDAs, INDs, and other filings. Will lead, facilitate, and coordinate meetings with Regulatory Authorities including the preparation of local agency briefing documents (including protocols and reports) and requests for advice meetings.Lead and provide input on product labels based on label requirements per region, as neededReview and approve CTAs prepared by CROs/consultants. Work closely with Global RA team to ensure that submissions are well planned and meet current standards and that submission schedules are adhered to.Contribute to the resolution of issues raised either internally, FDA or by Health Authorities to ensure a rapid and efficient resolution.Define and implement submission plans in conjunction with other team members/line manager.Participate in meetings and provide status updates and input to moderately complex aspects of the development programs.Initiate and update regulatory strategic plans for all US projects/products. Assess pros, cons and risks of the various strategic options and communicate to the workstream team members and management.Keep abreast of all pertinent laws, regulations, and guidance relevant to oncology, hematology, etc. and the specific product areas.Provide expertise in the interpretation of regulations and guidance relating to product development.Coordinate with the Global Regulatory Affairs group for global regulatory strategy and submissions.Maintain up to date knowledge of regulatory requirements and communicate in a timely manner any updates that may impact into the development programs. Interface with Senior Management to ensure consistency of regulatory strategy with corporate goals.Develop and maintain regulatory intelligence data particularly related to oncology and hematology products.Coordinate with consultants and contractors as required.Qualifications:This individual must be highly motivated and enjoy working in a fast-paced, challenging matrix environment.

Able to interact cross-functionally at all levels internally within pharma&, and externally with consultants/CROs.Must be flexible relative to responsibilities since pharma& is a small company and job scope/role will inevitably evolve as the company grows and matures. Needs to be able to operate at all levels within a project, from some oversight to hands-on management and execution of day-to-day activities.Broad understanding of drug development and oncology/hematology in particular.Competency in all FDA regulatory requirements is essential; global experience is a plus.Excellent verbal and written communication skills.Solid problem-solving capabilities with a flexible mindset and ability to multitask.Education and Experience:Minimum of BS in a relevant scientific discipline, advanced degree, or RACC certification preferred.At least

10 years US Regulatory Affairs experience and at least 15 years total pharmaceutical industry experience.Must have previous experience leading NDA submissions (and other filings)Regulatory Affairs experience in oncology/hematology is preferred, as well as experience with EU regulatory is advantageous.Experience with OPDP submissions preferred.Previous experience with companion diagnostic regulatory requirements preferredWorking Conditions:Home-based position. Limited travel required; estimated 20% of time or less.Position is home based in the US.Must be able to sit for long periods at a desk.

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