Senior Manager, Regulatory Affairs

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 MASH(metabolic dysfunction-associated steatohepatitis).

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 (RA) Senior Manager works collaboratively with the RA Director and other cross-functional team leaders and is responsible for managing the US IND and managing the oversight of regulatory information management (RIM) systems. The responsibilities will involve thorough preparation and completion of global regulatory submissions and active management of regulatory systems throughout the product lifecycle for EFX. This role will also involve projects that continuously improve or otherwise advance RA capabilities.

Job Responsibilities

• Leads project teams and actively participates in the development and writing of high-quality regulatory documents
  • Independently authors regulatory documents and critically reviews documents for submission readiness to Health Authorities (HAs) which include but are not limited to IND / CTA / BLA regulatory submissions (eg., general correspondence, information amendments, protocol amendments [protocols, CSRs, IB, investigator information updates, meeting requests/packages, periodic/safety reports])
  • Ensures work complies with established processes, templates, policies, and applicable regulatory guidance
  • Ensures supporting data are identified, obtained, and that rationales and company position are clearly and accurately presented
• Oversees and guides the preparation, compilation, and timely completion of regulatory submissions within designated local regions
  • Collaborates with regulatory counterparts, cross-functional contributors, and submission teams to resolve comments, address regional requirements, and drive alignment
  • Advances document review and approval stages of both internal and external outsourced regulatory activities, interacting with relevant stakeholders as necessary
  • Enhances delivery of Akero’s regulatory objectives by building effective internal and external relationships
• Manages Veeva Regulatory Information Management (RIM) and internal Akero systems
  • Partners with RA Director to conduct end-to-end administration of Veeva RIM, including but not limited to document workflow management, simple to complex submission compilation, correspondence/submission archiving, metadata entry, change control configuration, release update management, user access, and application/submission tracking
  • Archives and tracks Health Authority correspondence, queries, commitments, and other deliverables throughout the program lifecycle
• Facilitates regulatory team meetings and is responsible for effective and efficient conduct and follow-through
  • Participates and contributes to regulatory team meetings and is recognized as a knowledgeable resource for Regulatory Affairs in other departments
• Monitors regulatory intelligence, identifies/optimizes process improvement, and assists in the authoring/updating of SOPs
  • Understands the regulatory environment to leverage internal knowledge and monitors external regulatory intelligence to perform impact assessments on the development program
  • Contributes to the ongoing development and refinement of regulatory strategies, processes, standards, practices, efficiencies, and capabilities

Qualifications

Education and Experience

• Bachelor’s degree in a scientific discipline; additional/postgraduate qualifications (MS, PharmD, PhD, PMP, MBA) will be a distinct advantage
• 8-12 years regulatory experience within the pharmaceutical or biotech industries; experience managing projects with remote teams and through external alliances preferred
• Title will be commensurate with experience

Regulatory Affairs Experience

• Led or filed applications, including but not limited to INDs, CTAs, NDAs, BLAs, MAAs, or equivalents
• Proven track record of successfully managing and delivering regulatory projects in early to late stage (Phase 2-3) development
• In-depth knowledge of relevant Health Authorities (HA), as evidenced by past effectiveness and success with HA interactions
• Knowledge of clinical development, including responsibilities for successful management of development milestones, and/or marketing authorization, meeting facilitation, HA negotiations, and responses
• Ability to interpret HA policies and guidance and apply them as appropriate in product development and labeling regulatory activities for pharmaceutical products

Industry Experience

• Keeps current on global and regional trends in Regulatory Affairs with proven effectiveness in applying this knowledge to optimize team deliverables
• Previous experience of working with emerging markets and/or therapeutic areas with limited precedent would be an advantage but not essential
• Knowledge of Regulatory Affairs discipline throughout the product lifecycle
• Knowledge of domestic and international laws, regulations, and guidance that affect pharmaceutical products
• Prior experience overseeing Contract Research Organizations and external vendors

Soft skills

• Strong analytical skills, attention to detail, organization skills, and writing skills, as evidenced through accomplishments in past roles
• Must have a “can do” attitude and be “hands on” as and when required.
• Adaptable and flexible team player comfortable with ambiguity in fast-moving, dynamic, and matrixed environments.
• Agile learner, able to move effectively between detail and project strategy.
• Strong interpersonal and communication skills, with ability to rapidly understand and adapt to different team dynamics
• Strong negotiation and conflict resolution skills
• Ability to build strong relationships and to lead by influence.

Technical skills

• Understanding and working knowledge of the use of 21 CFR Part 11 compliant internal electronic systems for planning, preparing, tracking and archiving submissions to HAs
• Working knowledge of eCTD and ESG requirements
• Experience with Veeva Vault is strongly preferred
• Strong organizational and project management skills (familiarity with MS Office Suite, Veeva RIM, SharePoint, Smartsheet)
• Excellent project integration, planning, communication, and documentation skills. Familiarity with planning tools (MS Project, SmartSheet, Excel, PowerPoint, and Outlook).

Compensation

• Below is the pay range for this position that we reasonably expect to pay. Individual compensation is based on a number of factors including, experience, education and skill set, and geographic location. This range is for the San Francisco Bay Area, California location and may be adjusted to the labor market in other geographic areas. 

  Pay range: $170,000 - $205,000 per annum

Special Advisory 

Akero will not conduct interviews via text message or messaging platforms.  Please be vigilant in checking that the communication is, in fact, coming from Akero. If you are contacted by any individual or group using email addresses or other contact information that incorporates “akerotx” but do not use our exact domain, akerotx.com, please submit a report to the FTC.