Associate Director/Director, Program Management (Regulatory Submissions)

The Associate Director/Director, Program Management will 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 authorization filings. This individual will oversee the development and execution of project plans from initiation to completion, ensuring the plan is completed on time, in scope, and within budget. Additionally, they will work closely with teams to proactively identify potential risks and implement effective solutions. A successful candidate must have experience managing drug development projects, particularly initial marketing authorization applications, in a fast-paced environment, with a strong willingness to build relationships with cross-functional teams, dive into details, and address gaps as needed to ensure program success.

Responsibilities:

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, Clinical, Quality, CMC, Medical Writing)

Oversee project team delivery of the marketing authorization applications

Develop and own detailed integrated marketing authorization plans, including goals, deliverables, timelines, 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

Required Qualifications:

10+ years of relevant experience of project management experience in the biotech, pharmaceutical, or life sciences industry

Strong 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)

Education:

Bachelor’s degree in science, engineering, or a related field; advanced degree preferred

Associate Director: advanced degree 5+ years of experience

Director: advanced degree 8+ years of experience

This role may be hired at the Associate Director or Director level depending on candidate experience or business need.

Salary Range

$155,000—$190,000 USD

Salary Range (Associate Director)

$155,000—$190,000 USD

Salary Range (Director)

$192,000—$235,000 USD