Senior Manager Regulatory Affairs

Summary:

The Regulatory Affairs Senior Manager is a key member of the Akero drug development team and will closely partner with and report to the Senior Director, Regulatory Affairs.

  • Responsible for day-to-day regulatory activities of assigned projects
  • Manage regulatory submissions and timelines
  • Author document sections as needed
  • Support and manage preparation of meeting requests and briefing documents
  • Maintain regulatory archive, regulatory tracking tools, and infrastructure, as assigned
  • Conduct regulatory intelligence as assigned and builds increased awareness and knowledge of international pharmaceutical guidances, regulation, drug development process, and industry standard practice
  • Independently executes preparation, review, submission, and maintenance of regulatory applications, including initial applications, routine amendments, annual reports, IND safety reports, and correspondence with global Health Authorities
  • Responsible for regulatory start up and maintenance activities for global clinical studies, oversight of regulatory tracking tools, archives, and infrastructure as assigned
  • Participates in cross-functional teams, providing regulatory feedback and support
  • Partners with external vendors in support of regulatory document preparation and submission

 

Technical Requirements & Skills:

  • Knowledgeable of international pharmaceutical guidance, regulations, drug development process, and industry standard practices.
  • Highly proficient in written, oral, and interpersonal communications in English
  • High attention to detail; ability to organize, prioritize, and delegate assigned project
  • Strong experience in IND and CTA filings. NDA/BLA/MAA filing experience preferred.
  • Exceptional influencing, partnership, and collaboration skills
  • Well-prepared, competent, and confident when interacting with senior management, health authorities, and internal and external partners
  • Able to prospectively identify potential problems and to partner effectively and positively to solve issues
  • Proficient user of standard MS Office suite (eg, Word, Excel), experience using electronic document management systems and document review tools desirable.

 Qualifications:

  • Minimum of 6 years or equivalent relevant experience in regulatory affairs
  • Bachelor’s degree required. Advanced degree in life sciences strongly preferred.

Actual level, title, and compensation will be commensurate with education and experience.