Associate Director/Director, Program Management (Regulatory Submissions)

Responsibilities

• Required location: Waltham, MA (hub-based, onsite 3-4 days per week)
• 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
• EQUAL EMPLOYMENT OPPORTUNITY INFORMATION:

Benefits

Additional Information

At Kailera, we are bold, authentic and committed to our mission of developing therapies that give people the power to transform their lives and elevate their overall health. Rooted in an entrepreneurial spirit and a team-oriented culture, we are working together to advance Kailera's mission to advance novel therapies for obesity and related conditions. We are passionate about creating an inclusive workplace that promotes collaboration, integrity, and excellence. As we expand, we seek the most talented individuals with diverse backgrounds, cultures, perspectives, and experiences to join our team.

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