Regulatory affairs Jobs in Denver, CO

Senior Manager, Regulatory Affairs

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

Manages Veeva Regulatory Information Management (RIM) and internal Akero systems

Facilitates regulatory team meetings and is responsible for effective and efficient conduct and follow-through

Monitors regulatory intelligence, identifies / optimizes process improvement, and assists in the authoring / updating of SOPs

Qualifications

Education and Experience

Regulatory Affairs Experience

Industry Experience

Soft skills

Technical skills

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.