Regulatory Affairs Director

3 days ago

South San Francisco, California, United States Abdera Therapeutics Full time
About Abdera Therapeutics

Abdera Therapeutics is a pioneering precision oncology company dedicated to developing innovative targeted radiation therapies. Our cutting-edge technology platform enables the rapid development of safe and efficacious treatments for cancer patients with limited options.

Job Summary

We are seeking a highly experienced Regulatory Affairs professional to join our growing team. As a key member of our regulatory team, you will be responsible for developing and implementing regulatory strategies and contingencies to support our development objectives.

Key Responsibilities
  • Develop and implement regulatory strategies and contingencies for assigned programs.
  • Lead and prepare FDA submissions.
  • Participate in global project team meetings and provide regulatory support and guidance.
  • 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 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 start-up environment and effectiveness to deliver in low-structured environments.

Abdera Therapeutics is an equal opportunity employer committed to diversity and inclusion in the workplace. We prohibit harassment of any kind and any form of discrimination based on protected characteristics as outlined by federal, state, or local laws.

  • Regulatory Affairs Director

    3 days ago

    South San Francisco, California, United States BioSpace, Inc. Full time

    Job Title: Regulatory Affairs DirectorAlumis Inc. is seeking an exceptional Regulatory Affairs Director to provide leadership and support to global regulatory activities. The ideal candidate will have a strong background in regulatory affairs, with experience in developing and implementing regulatory strategies to facilitate the progress of assigned...

  • Regulatory Affairs Director

    1 day ago

    South San Francisco, California, United States BioSpace, Inc. Full time

    Job Title: Regulatory Affairs DirectorAlumis Inc. is seeking an exceptional Regulatory Affairs Director to provide leadership and support to global regulatory activities. The ideal candidate will have a strong background in drug development, regulatory affairs, and immunology or rare disease/orphan drug development experience.Key Responsibilities:Develop and...

  • Regulatory Affairs Director

    3 days ago

    South San Francisco, California, United States Synectics Full time

    Job Title: Regulatory Affairs Associate Director/DirectorJoin Synectics, a leading pharmaceutical company, as a Regulatory Affairs Associate Director/Director and take on a challenging role in shaping the future of oncology drug development.Responsibilities:Develop and implement global regulatory strategies to support the development of multiple oncology...

  • Senior Director Regulatory Affairs

    3 days ago

    South San Francisco, California, United States Structure Therapeutics Full time

    Job Title: Senior Director, Regulatory AffairsStructure Therapeutics is seeking a seasoned Senior Director, Regulatory Affairs to lead the development and execution of regulatory strategies and operations for our products. As a key member of our leadership team, you will be responsible for guiding our products through development, approval, and post-approval...

  • Regulatory Affairs Director

    4 weeks ago

    South San Francisco, California, United States Alumis Full time

    Job Title: Director, Regulatory StrategyAlumis Inc. is a precision medicines company dedicated to transforming the lives of patients with autoimmune diseases. Our mission is to fundamentally change the outcomes for these patients.We are seeking an exceptional individual to provide leadership and support to global regulatory activities, driving Alumis'...

  • Regulatory Affairs Director

    3 weeks ago

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

    Job Title: Director/Senior Director RegulatoryAbout Abdera TherapeuticsAbdera Therapeutics is a precision oncology company developing next-generation targeted radiation therapies. We are a rapidly growing company seeking key new team members who thrive at the cutting-edge of innovation.Job SummaryWe are looking for a highly experienced and skilled...

  • Regulatory Affairs Director

    3 weeks ago

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

    Job Title: Director/Senior Director RegulatoryAbout Abdera TherapeuticsAbdera Therapeutics is a precision oncology company developing next-generation targeted radiation therapies. We are a rapidly growing company seeking key new team members who thrive at the cutting-edge of innovation.Job SummaryWe are looking for a highly experienced and skilled...

  • Regulatory Affairs Director

    4 weeks ago

    San Francisco, California, United States Daiichi Sankyo, Inc. Full time

    Unlock Your Potential in Regulatory AffairsDaiichi Sankyo, Inc. is a leading pharmaceutical company dedicated to delivering innovative therapies to improve patient outcomes. We are seeking a highly skilled Regulatory Affairs Director to join our team and contribute to the success of our regulatory strategy.About the RoleThis is an exciting opportunity to...

  • Regulatory Affairs Director

    3 weeks ago

    South San Francisco, California, United States Alumis Full time

    Job Title: Regulatory Affairs DirectorAlumis Inc. is a precision medicines company dedicated to transforming the lives of patients with autoimmune diseases. We are seeking an exceptional individual to provide leadership and support to global regulatory activities, driving our strategic vision for obtaining worldwide approvals to market our products.Key...

  • Global Regulatory Affairs Director

    3 days ago

    South San Francisco, California, United States Spectraforce Technologies Full time

    Job Title: Global Regulatory Affairs Associate Director/DirectorLocation: South San Francisco, CA locationDuration: 06+ monthsDescription:Position Overview:We are seeking a highly skilled Regulatory Affairs Associate Director/Director to join our growing regulatory team. As the Global Regulatory Lead, you will develop and implement global regulatory...

  • Global Regulatory Affairs Director

    1 day ago

    South San Francisco, California, United States Spectraforce Technologies Full time

    Job Title: Global Regulatory Affairs Associate Director/DirectorLocation: South San Francisco, CADuration: 06+ monthsDescription:We are seeking a highly experienced Regulatory Affairs Associate Director/Director to join our growing regulatory team. As the Global Regulatory Lead, you will develop and implement global regulatory strategies to support the...

  • Senior Director, Regulatory Affairs Lead

    1 day ago

    South San Francisco, California, United States Structure Therapeutics Full time

    Job Title: Senior Director, Regulatory AffairsStructure Therapeutics is seeking a highly experienced Senior Director, Regulatory Affairs to lead the development and execution of regulatory strategies and operations for our biotechnology products. As a key member of our regulatory team, you will be responsible for ensuring compliance with regulatory...

  • Senior Director of Regulatory Affairs

    2 days ago

    San Francisco, California, United States KMR Search Group Full time

    Job Title: Senior Director, Regulatory AffairsJob Description Job Summary:This role will support global CMC regulatory activities related to investigational/commercial large molecule biologic products. The Senior Director, Regulatory Affairs will serve as a strategic business partner in providing regulatory CMC guidance to various development teams and for...

  • Senior Director Regulatory Affairs

    3 days ago

    San Francisco, California, United States KMR Search Group Full time

    Job Title: Senior Director, Regulatory AffairsJob DescriptionJob Summary:This position will support global CMC regulatory activities related to investigational/commercial large molecule biologic products. The successful candidate will serve as a strategic business partner in providing regulatory CMC guidance to various development teams and for preparation...

  • Regulatory Affairs Director

    3 days ago

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

    About Abdera TherapeuticsAbdera Therapeutics is a pioneering precision oncology company dedicated to developing innovative targeted radiation therapies. Our cutting-edge modular technology platform enables the rapid development of safe and efficacious treatments for cancer patients with limited options.Job SummaryWe are seeking a highly experienced...

  • Regulatory Affairs Director

    3 days ago

    South San Francisco, California, United States Annexon Bioscience Full time

    Job SummaryWe are seeking a highly skilled and experienced Regulatory Affairs professional to join our team at Annexon Biosciences. As a key member of our regulatory team, you will be responsible for providing global regulatory leadership and direction to support the development, registration, and life-cycle management of our innovative programs.Key...

  • Executive Director/Senior Director, Regulatory Affairs

    3 weeks ago

    South San Francisco, California, United States BioSpace, Inc. Full time

    Job SummaryAnnexon Biosciences is seeking an experienced Executive Director/Senior Director, Regulatory Affairs to provide global regulatory leadership and direction to support the development, registration, and life-cycle management of innovative programs within the Annexon portfolio.Key ResponsibilitiesDevelop and implement regulatory strategies and plans...

  • Director, Regulatory Affairs

    3 weeks ago

    San Jose, California, United States Stryker Full time

    Job Title: Director, Regulatory AffairsStryker Corporation is seeking a highly skilled and experienced Director, Regulatory Affairs to join our team. As a key member of our regulatory affairs team, you will be responsible for developing and implementing regulatory strategies to ensure compliance with international standards and government regulations.Key...

  • Regulatory Affairs Director

    2 weeks ago

    San Diego, California, United States CorDx Full time

    Job Title: Associate Director of Regulatory AffairsCorDx is a leading biotech organization dedicated to delivering innovative medical device solutions. We are seeking an experienced Associate Director of Regulatory Affairs to lead our regulatory submissions and ensure compliance with applicable regulations.Key Responsibilities:Prepare and submit regulatory...

  • Regulatory Affairs Director

    3 days ago

    San Diego, California, United States Gossamer Bio Full time

    Job SummaryWe are seeking a highly skilled and experienced Regulatory Affairs professional to join our team at Gossamer Bio. As a Director / Senior Director, CMC Regulatory Affairs, you will be responsible for developing and executing innovative CMC regulatory strategies in support of the global development and commercialization of a drug/device combination...