Director, Regulatory Affairs-CMC & Device

Company Background
Akero Therapeutics is a clinical stage biopharmaceutical company focused on discovering and developing transformational treatments for patients with serious metabolic diseases marked by high unmet need. Our current focus is on advancing our lead program efruxifermin (EFX) to provide a powerful new treatment for patients with NASH, a disease for which there are currently no marketed therapies.

We are a team of problem solvers dedicated to pursuing bold scientific approaches to build a brighter future for patients. Our diverse skill sets and backgrounds, desire to learn from each other and collaborative spirit breed a culture where everyone feels inspired to bring their best thinking to work, and to bring out the best in others.

Job Summary
The Regulatory Affairs Director, CMC, and Device is a key member of the Akero drug development team and will closely partner with and report to the Senior Director, Regulatory Affairs. This position will lead and manage the regulatory CMC and device aspects of EFX through the product life cycle for the US, EU, and other markets.

Job Responsibilities

• Responsible for providing scientific and regulatory guidance on Drug Substance, Drug Product, and Medical Device Combination Product (MDCP) requirements to project teams to support development and marketed products; ensures that the information available will meet regulatory expectations for intended countries
  Identifies, communicates, and achieves stakeholder alignment on innovative and scientifically sound approaches to gain global approval of the combination product and the device constituent(s)
• Executes regulatory strategies by leading the development, authoring, and review of technical submission components (CMC and device) to support global clinical trial applications, amendments, new registrations, post-approval supplements, annual reports, and responses to health authority questions
• Performs risk assessments for strategic decisions to address significant issues: apply the appropriate level of risk, define the probability of success, and recommend any mitigations. Communicates recommendations to stakeholders to obtain alignment
• Monitors the global regulatory environment to identify changes to technical (CMC and MDCP) regulations; communicates changes to affected product teams (both internally and externally to the organization). Works closely with product teams to adapt strategies and address the evolving regulatory expectations
• Authors document sections as needed
• Partners with external vendors in support of regulatory document preparation and submission
• Independent contributor
• Responsible for ensuring the regulatory responsibilities outlined in global device regulations (e.g., MDR) are met

Qualifications

• Bachelor’s degree in a scientific discipline is required. Advanced degree preferred
• 10 years or equivalent relevant experience in pharmaceutical CMC and Device Regulatory Affairs. 4 years of professional experience in regulatory affairs or in quality management systems relating to medical devices is required

Technical Requirements and Skills

• Experience with injectable drug products, aseptic manufacturing processes, and medical devices
• Knowledgeable of international pharmaceutical, combination product and device guidance’s, regulations, the drug development process, and industry standard practices
• Strong experience in IND and CTA combination product filings. NDA/BLA/MAA filing experience preferred
• Highly proficient in written, oral, and interpersonal communications in English
• High attention to detail; ability to organize, prioritize, and delegate assigned projects
• Experience in assessing changes for regulatory impact
• 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
• Detailed-oriented and comfortable with broad responsibilities in a fast-paced environment
• Proficiency in MS Office suite (e.g., Word, Excel), experience using electronic document management systems and document review tools desirable
• Experience with Veeva Vault is a plus