Senior Manager, Regulatory Affairs

• 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

• 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

• 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

• 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

• 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.

• 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).

Akero Therapeutics