Kailera Therapeutics, Inc.
AssociateDirector/Director,ProgramManagement(RegulatorySubmissions)
“Associate Director/Director, Program Management (Regulatory Submissions) at Kailera Therapeutics, Inc.. Skills: Program Management, Regulatory Submissions, Cross-functional Team Leadership, Project Planning and Execution, Marketing Authorization Applications. collaborate with cross-functional teams, including clinical, regulatory, non-clinical, and technical operations, to lead regional and global cross-functional teams in the planning, preparation, and delivery of compliant marketing authorizat”
Industry & Context.
Excellent problem-solving and organizational skills; analytical skills; proactively identify potential risks and implement effective solutions
What They're Looking For.
Must Have
10+ years of relevant experience of project management experience in the biotech, pharmaceutical, or life sciences industry, understanding of drug development and how biotech functions integrate, Experience in managing cross-functional teams and complex projects inate-stage drug development, with experience managing global marketing authorization submissions (NDA, BLA, MAA) preferred, Demonstrated project management and interpersonal skills, Excellent problem-solving and organizational skills, attention to detail, and analytical skills, Ability to manage multiple priorities in a fast-paced, dynamic environment, Comfortable navigating ambiguity and driving clarity, Responds to changing priorities and uncertainty by maintaining composure, resilience, and an open mind while embracing change in an evolving environment, Proven record of collaboration and excellent communication, Proficient in project management tools (e. g. , Smartsheet, MS Project, Excel, think-cell, OnePager), Bachelor’s degree in science, engineering, or a related advanced degree preferred, Associate Director: advanced degree 5+ years of experience, Director: advanced degree 8+ years of experience
Nice to Have
global marketing authorization submissions (NDA, BLA, MAA) preferred
What You'll Do.
collaborate with cross-functional teams
and technical operations
to lead regional and global cross-functional teams in the planning
and delivery of compliant marketing authorization filings
oversee the development and execution of project plans from initiation to completion
ensuring the plan is completed on time
work closely with teams to proactively identify potential risks and implement effective solutions
Contribute to and lead the execution of submission strategies in alignment with corporate objectives and regulatory requirements
Lead and manage cross-functional submission team meetings and workstreams (Regulatory
Oversee project team delivery of the marketing authorization applications
Develop and own detailed integrated marketing authorization plans
and resource requirements
Monitor project progress and provide regular updates to Program Leader and other stakeholders
ensuring clear communication and transparency
Own program reports / dashboards to executive and other governance teams
Establish best practices and SOPs as needed for marketing application related submission processes
How You'll Work.
Team & Collaboration
collaborate with cross-functional teams, including clinical, regulatory, non-clinical, and technical operations; lead regional and global cross-functional teams; Lead and manage cross-functional submission team meetings and workstreams (Regulatory, Clinical, Quality, CMC, Medical Writing); build relationships with cross-functional teams; Proven record of collaboration
Communication Scope
excellent communication
Process & Methodology
project management, cross-functional coordination, planning, preparation, delivery, development and execution of project plans, monitoring project progress, providing regular updates, owning program reports / dashboards, establishing best practices and SOPs
Applying for this Associate Director/Director, Program Management (Regulatory Submissions) role?
Most applicants get filtered before a human reads their resume. See if yours makes the cut.
How to Apply on Greenhouse
- Create a Greenhouse profile before applying — it saves time across multiple applications.
- Upload your resume as a PDF; the parser handles it better than Word.
- Answer all knockout questions carefully — wrong answers auto-reject before a human sees you.
- Enable email notifications to track application status in real time.
ANONYMOUS · UNFILTERED
What do employees actually say about Kailera Therapeutics, Inc.?
Real rants from real employees. Read before you apply.