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Head of Regulatory Affairs

2 months ago

San Diego, California, United States BioPhase Full time

Position Overview:

The Director of Regulatory Affairs is pivotal in overseeing the regulatory operations within BioPhase. This role entails managing the submission of multiple original Investigational New Drug (IND) applications annually and overseeing various active INDs in Phase 1 and 2 clinical trials across regions including the US, Canada, EU, and APAC.

Key Responsibilities:

  • Oversee the filing of numerous original INDs for new product candidates each year.
  • Manage concurrent active INDs and Clinical Trial Applications (CTAs) in Phase 1 and 2 trials, ensuring timely completion and tracking of amendments, safety reports, annual reports, and responses to inquiries from global regulatory authorities.
  • Collaborate with project teams to gather necessary information and documentation to ensure timely and accurate regulatory submissions aligned with corporate objectives.
  • Handle the preparation, submission, distribution, and archiving of all regulatory documents, including original INDs, amendments, safety reports, and annual reports.
  • Assist in the preparation of IND/CTR documents in eCTD format, ensuring compliance with regulatory standards and maintaining up-to-date templates.
  • Engage with regulatory agencies to facilitate communication and compliance.
  • Support Quality Assurance, pre-clinical and clinical teams, Chemistry, Manufacturing, and Controls (CMC), and other stakeholders in maintaining active INDs and adhering to company policies.
  • Stay informed about evolving regulatory requirements in the US and other ICH regions.
  • Conduct regulatory research related to company products and contribute to strategic regulatory decision-making.
  • Implement and contribute to departmental policies and procedures, fostering a culture of continuous improvement.

Qualifications:

  • Bachelor's degree; advanced education is advantageous.
  • Experience in oncology is preferred.
  • Hands-on experience with IND submissions using eCTD submission software is essential.
  • Familiarity with US drug regulations and ICH guidance documents is required.
  • Understanding of the regulatory pathway from pre-IND to Phase 2 submissions for investigational new drugs is necessary.
  • Ability to manage multiple projects and submissions simultaneously is crucial.
  • Strong oral and written communication skills, along with technical writing and editing capabilities, are mandatory.
  • Exceptional organizational skills and attention to detail are required.
  • Demonstrated leadership and interpersonal skills, with the ability to thrive in a collaborative project team environment.