Senior Director, Regulatory Affairs

Leap Therapeutics is seeking motivated individuals with regulatory affairs experience to be part of a growing oncology company. Successful candidates will work within a highly collaborative team environment to lead the development and implementation of a consolidated regulatory strategy across the development pipeline to meet company’s business objectives.

Sr. Director, Regulatory Affairs

Reports to the VP, Clinical Development

 

The candidate must have prior experience managing clinical studies, CROs and vendors within a sponsor company. The experience must include activities associated with clinical study conduct from start-up to close out, data clean up, and report generation. A thorough understanding of FDA regulations, GxPand ICH are required along with strong interpersonal and organization skills. Attention to detail is imperative. The Sr. Director will work independently and within a group setting to act as liaison between Regulatory Affairs and other functional areas including external CROs, partners, and consultants in the planning, organizing, and preparing of regulatory documents for submission to governmental regulatory agencies. This individual will have a solid understanding of global regulations, GCP and ICH guidance’s and experience with regulatory submissions, including INDs, NDAs, international clinical trial applications, and marketing applications in Common Technical Document format. Lead key, strategic regulatory CMC activities, developing and implementing global regulatory strategy for investigational products. The Sr. Director will be the first regulatory position and will have an opportunity to build a team.

 

Responsibilities

The Senior Director Regulatory Affairs will manage and provide strategic leadership for regulatory strategy, agency interactions, and submissions for US FDA, EMA, and other key market Health Authorities as applicable and ensure these activities are consistent with the overall global strategy and activities. An integral part of this role is to foster strong relationships and advocacy with FDA as well as other international regulatory authorities, as required. This leadership role will entail oversight of vendors for the preparation of the regulatory submissions and interaction with key members of the Project Teams and agencies/health authorities. This individual will function as a key team member of the team, influencing the development strategy and to defend regulatory position with health authorities.

Specific responsibilities include:

  • Develop, lead and implement global regulatory strategy

  • Act as primary contact with regulatory agencies

  • Lead the preparation of submissions, such as INDs, briefing packages and fast track applications

  • Lead the development of clinical development plans with cross-functional teams

  • Provide regulatory expertise and support nonclinical and clinical areas for investigational projects.

  • Address complex issues by providing solid regulatory solutions and guidance to senior management and cross-functional teams

  • In collaboration with functional team members, assist in the design of clinical study plans, development of statistical and interim analysis plans, and interpretation of clinical study data

  • Provide operational expertise when “hands on” support is needed

  • Advise Vice President of Clinical Development and Vice President of CMC on the status of Regulatory Affairs strategies and tactics, procedures and practices

  • Manage RA CMC activities to support global clinical trials investigational products, developing strategies for appropriate filings and responses to health authority queries.

  • Provide and oversee strategic direction and guidance to CMC, Quality Assurance, and Commercial on both global and key strategic business initiatives

  • Ensure compliance of regulatory strategies and submissions

  • Provide direct Regulatory oversight to all Non-clinical, Clinical and CMC activities.

  • Identify and assess regulatory risks for projects or programs.

  • Participate in audits as required; oversee follow-up activities and ensure timely implementation and completion of corrective action plans in close cooperation with QA.

  • Monitor company progress toward fulfillment of regulatory commitments.

  • Keep senior management apprised of expected changes to the regulatory landscape affecting existing and future products.

  • Maintain knowledge of global competitive landscape, regulatory environment, regulations and guidances, and current industry practice.

  • Author and review standard operating procedures (SOPs); ensure SOPs are in compliance with current regulatory requirements and provide regulatory support for corporate quality assurance efforts.

  • Create new processes to support the evolution of the company

 

Education / Experience / Skills:

  • Bachelor’s degree in scientific discipline; advanced scientific degree preferred with 15+ years pharmaceutical industry experience, including 10 years in Regulatory Affairs.

  • Minimum of 7 years of regulatory experience within the drug development and approval process in INDs, CTAs and marketing applications

  • 5 years or more of recent therapeutic experience in Oncology; Experience in multiple phases of oncology development

  • Successful track record of FDA interactions

  • Experience working with innovator products and designing and executing creative development strategies are highly desirable. In-depth understanding of the drug development process for all phases of pharmaceutical development

  • Must have a solid understanding of FDA regulations and ICH guidance’s, as well as a comprehensive knowledge of the drug development process.

  • Able to handle multiple projects and exercise good judgement in prioritizing tasks

  • Demonstrate ability to work independently and within a group setting, and to interact effectively with various functional groups.

  • Strong communication skills (oral, written, and interpersonal) and the ability to identify and recommend solutions to problems.

  • High level of attention to detail, and be proficient with Microsoft Office applications, Adobe and document management templates.

  • Global experience required

  • Domestic and occasional International travel may be necessary.

  • Experience with companion diagnostic development is preferred

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