Senior Manager Regulatory Affairs
The Senior Manager Regulatory Affairs is a key member of the Akero drug development team and will closely partner with and report to the Senior Director, Regulatory Affairs. Actual level, title, and compensation will be commensurate with education and experience.
- 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.