Sr. Manager, Regulatory Affairs

4 days ago

South San Francisco, United States Structure Therapeutics Full time
Job DescriptionJob DescriptionSalary:

Structure Therapeutics develops lifechanging medicines for patients using advanced structurebased and computational drug discovery technology. The companys platform combines the latest advancements in visualization of molecular interactions, computational chemistry, and data integration to design orally available, superior small molecule medicines that overcome current limitations of biologic and peptide drugs. We are advancing a clinicalstage pipeline of differentiated treatments focused on chronic diseases with high unmet need, including cardiovascular, metabolic, and pulmonary conditions.


Structure Therapeutics is led by an experienced group of international drug innovators and financed by top-tier global life sciences investors. The company has completed an initial public offering (IPO) in February of 2023. With offices in California and Shanghai, Structure Therapeutics has the benefit of being at the center of life science innovation in both the US and China and capitalizing on the strengths of each geographic location.


POSITION SUMMARY

This individual will report to the Sr. VP, Regulatory Affairs and Quality. In this individual contributor role, you will support the preparation and implementation of regulatory strategies for new drug development projects in the US and other regions. This is a hybrid role that will require 3 days in the office (2 core days, 1 flex day). #LIHybrid


Essential Duties and responsibilities

  • Support the preparation and implementation of regulatory strategies, for new drug development projects in the US and in other regions
  • Provide specific regulatory input for development projects
  • Collaborate with and manage Regulatory consultants and other vendors when required
  • Support the initiative of electronic submissions
  • Oversees regulatory submissions or regulatory-related projects
  • Work with the regulatory team to define the scope of the project/submission
    • Plan and monitor each task throughout a project/submission to ensure it is completed in a timely manner
    • Manage project resources
    • Communicate the project/submission status effectively to internal and external stakeholders
    • Proactively identify risks to the project/submissions success, inform applicable team members, and propose solutions
    • Document each step in the process, using various project management tools.
    • For each submission build and manage a risk register
    • Partner with the team to ensure top quality and success of a regulatory project/submission
  • In partnership with the regulatory team create and lead a recurring cross-functional team meetings focused on some strategic but mostly operational aspects of the submission/project
  • Create and maintain a list of team members, a list of project deliverables, a project timeline, roles and responsibilities matrix, and any other applicable documents that are key to the projects/submission success
  • In collaboration with Regulatory Operations, manage the external vendors that support regulatory activities
  • Keep the regulatory activity tracker updated be proactive
  • Work with the regulatory team and functional lines to build and update regulatory response tables
  • Communicate frequently and effectively. This includes regulatory meeting agendas, meeting notes, and organized cloud-based materials
  • In partnership with the Regulatory Team:
    • Identify the scope of the kickoff meeting and the key stakeholders
    • Coordinate meeting logistics, speakers, and content
    • Manage the agenda, invites, and stakeholder access to the meeting
    • Follow up after the meeting with applicable documentation (presentations, notes, etc.


REQUIREMENTS

Education

  • Bachelors or masters degree in a scientific field (advanced degree such as PhD, PharmD, or MD is a plus)

Experience

  • 57+ years in the pharmaceutical or biopharmaceutical industry, with 35+ years in regulatory affairs and strategy
  • Product Launches: 23+ years of experience with cell therapy product launches preferred
  • Skills: Strong verbal, written, and interpersonal communication; demonstrated ability to manage projects independently; effective cross-functional teamwork
  • Expertise: Comprehensive understanding of regulatory processes and drug development, with proven adaptability in a dynamic, fast-paced environment

The target salary range for this full-time role is $170,000 - $200,000 + bonus + equity + benefits. Structure Therapeutics determines salary ranges based on level and scope of responsibilities, as well as location. Individual pay is further determined by additional factors, including relevant experience, specific job skills, education and training. More details about the specific salary range for your location will be discussed with you during the hiring process by the StructureTx Talent Acquisition Team.

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