Regulatory Affairs Director

4 weeks ago

South San Francisco, California, United States Abdera Therapeutics Full time
Job Description

Job Summary

Abdera Therapeutics Inc. is a precision oncology company developing innovative targeted radiation therapies. We are seeking a highly experienced Regulatory Affairs professional to join our team as a Director/Senior Director Regulatory. The successful candidate will be responsible for developing and implementing regulatory strategies and contingencies for assigned programs, leading and preparing FDA submissions, and providing guidance and expertise to senior management and other departments on all regulatory issues.

Key Responsibilities

  • Develop and implement regulatory strategies and contingencies for assigned programs.
  • Lead and prepare FDA submissions.
  • Provide guidance and expertise to senior management and other departments on all regulatory issues.
  • Serve as the primary contact with FDA and liaise, negotiate, and orchestrate all interactions with FDA.
  • Provide mentorship to multidisciplinary teams on the content, format, style, and architecture of an Investigational New Drug (IND) application.
  • Edit or lead the editing of scientific sections of regulatory documentation against the regulatory requirements.
  • Manage the organization, preparation, and review of IND amendments, annual reports, and other regulatory documents and correspondence.
  • Participate in due diligence activities and communicate regulatory risks before products/devices development, acquisition, or in-licensing of new products or devices.
  • Provide support on labeling and advertising matters.
  • Maintain knowledge of regulatory environment, global regulations, and guidance.
  • Contribute to the development and maintenance of Regulatory Affairs working practices and procedures.
  • Support in the preparation of the Regulatory Affairs department budget.

Requirements

  • Bachelor's degree in chemistry, biochemistry, pharmacy, pharmacology, or related scientific discipline required.
  • Master's Degree, PharmD, or PhD preferred.
  • 10+ years of relevant experience in a similar role within the biotechnology or pharmaceutical industry.
  • 7+ years in regulatory affairs.
  • Radio expertise.
  • Ability to interpret and understand US regulations governing pharmaceutical industry.
  • Comprehensive understanding of drug development and related concepts, such as clinical trial design, statistics, and clinical pharmacology.
  • Strong written, verbal, and interpersonal communication skills, with the ability to effectively interact with individuals at all levels across the organization.
  • Prior experience with FDA submissions required.

Skills and Abilities

  • Ability to critically review regulatory scientific documents across non-clinical and clinical disciplines.
  • Builds a learning environment that recognizes the value of each contributor and promotes a solutions orientation.
  • Ability to constructively challenge, question, and provide creative suggestions for regulatory trial processes in order to create the most efficient and effective methods to deliver quality clinical trial services.
  • Willingness to collaborate with team to identify and implement best practices for optimizing performance.
  • Naturally connects and builds strong relationships with others, demonstrating strong emotional intelligence and an ability to communicate clearly and persuasively.
  • Strong leadership skills in leading team members and vendors.
  • Demonstrated ability to manage and coordinate internal and external resources independent from managerial oversight.
  • Strong organizational, communication, and interpersonal skills.
  • Ability to prioritize, delegate, and execute to meet project deadlines.
  • Proactive, innovative, with excellent problem-solving skills.
  • Excellent computer skills (Microsoft Office Suite, Project, Word, Excel, PowerPoint, Outlook, and IXRS/EDC platforms).
  • At ease in a start-up environment and effectiveness to deliver in low-structured environments.

Abdera Therapeutics is an Equal Opportunity Employer

Abdera Therapeutics is committed to diversity and inclusion in the workplace. We prohibit harassment of any kind and any form of discrimination including but not limited to discrimination based on race, color, sex, religion, marital status, sexual orientation, national origin, disability, veteran status, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws.

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