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.
- 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.