At Akero Therapeutics, we are a team of problem solvers dedicated to pursuing bold scientific approaches to build a brighter future for patients. We are seeking a Senior Manager, Regulatory Affairs to join our dynamic team. This individual will work collaboratively with the RA Director and cross-functional leaders to manage the US IND and oversee our Regulatory Information Management (RIM) systems, ensuring high-quality regulatory submissions and effective system management throughout the product lifecycle for EFX.
What You'll Do
- Lead project teams and actively participate in the development and writing of high-quality regulatory documents.
- Independently author regulatory documents and critically review documents for submission readiness to Health Authorities.
- Ensure work complies with established processes, templates, policies, and applicable regulatory guidance.
- Oversee and guide the preparation, compilation, and timely completion of regulatory submissions within designated local regions.
- Collaborate with regulatory counterparts and cross-functional contributors to resolve comments, address regional requirements, and drive alignment.
- Manage Veeva Regulatory Information Management (RIM) and internal Akero systems, partnering with the RA Director for end-to-end administration.
- Archive and track Health Authority correspondence, queries, commitments, and other deliverables.
- Facilitate and contribute to regulatory team meetings, serving as a knowledgeable resource.
- Monitor regulatory intelligence, identify process improvements, and assist in authoring/updating SOPs.
- Contribute to the ongoing development and refinement of regulatory strategies, processes, and capabilities.
What We're Looking For
- Bachelor’s degree in a scientific discipline.
- 8-12 years of regulatory experience within the pharmaceutical or biotech industries.
- Proven track record of leading or filing applications (e.g., INDs, CTAs, NDAs, BLAs, MAAs).
- Experience successfully managing and delivering regulatory projects in early to late stage (Phase 2-3) development.
- In-depth knowledge of relevant Health Authorities and successful HA interaction history.
- Ability to interpret HA policies and guidance and apply them to product development.
- Knowledge of domestic and international laws, regulations, and guidance affecting pharmaceutical products.
- Strong analytical, organizational, and writing skills with a “can do,” hands-on attitude.
- Adaptable team player comfortable with ambiguity in fast-moving, dynamic, matrixed environments.
- Strong interpersonal, communication, negotiation, and conflict resolution skills.
- Working knowledge of 21 CFR Part 11 compliant systems, eCTD, and ESG requirements.
- Strong organizational and project management skills (MS Office Suite, Veeva RIM, SharePoint, Smartsheet).
Nice to Have
- Additional/postgraduate qualifications (MS, PharmD, PhD, PMP, MBA).
- Experience managing projects with remote teams and through external alliances.
- Proven effectiveness in applying global regulatory intelligence to optimize team deliverables.
- Previous experience working with emerging markets or therapeutic areas with limited precedent.
- Prior experience overseeing Contract Research Organizations and external vendors.
- Experience with Veeva Vault is strongly preferred.
- Familiarity with planning tools (MS Project, SmartSheet, Excel, PowerPoint, Outlook).
Technical Stack
- Veeva Regulatory Information Management (RIM), Veeva Vault
- 21 CFR Part 11 compliant internal electronic systems
- eCTD, ESG
- MS Office Suite, SharePoint, Smartsheet, MS Project, Excel, PowerPoint, Outlook
Team & Environment
You will work collaboratively with the RA Director and other cross-functional team leaders, reporting directly to the RA Director. Our diverse skill sets and collaborative spirit inspire everyone to bring their best thinking to work and bring out the best in others.
Benefits & Compensation
- Compensation: $170,000 - $205,000 per annum.
Work Mode
This is a remote position open to candidates in the San Francisco Bay Area, California.
Akero Therapeutics is an equal opportunity employer.
