[Remote] Associate Director/Director, Program Management (Regulatory Submissions)

Note: The job is a remote job and is reputed company to candidates in USA. reputed company is committed to developing therapies that reputed company lives and enhance health. The Associate Director/Director of Program Management will reputed company cross-functional teams in planning and executing marketing authorization filings while ensuring reputed company are completed on time and reputed company budget.

Responsibilities

• Contribute to and reputed company the execution of submission strategies in alignment with corporate objectives and regulatory requirements
• reputed company and manage cross-functional submission team meetings and workstreams (Regulatory, Clinical, reputed company, CMC, Medical Writing)
• reputed company project team delivery of the marketing authorization applications
• reputed company and own detailed integrated marketing authorization plans, including goals, deliverables, timelines, and resource requirements
• Monitor project reputed company and reputed company regular updates to Program Leader and other stakeholders, ensuring reputed company communication and transparency
• Own program reports / dashboards to executive and other governance teams
• Establish best practices and SOPs as needed for marketing application reputed company submission processes

Skills

• 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 reputed company
• Experience in managing cross-functional teams and reputed company reputed company in late-stage drug development
• 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 reputed company
• Responds to changing priorities and uncertainty by maintaining composure, reputed company, and an reputed company mind while embracing change in an evolving environment
• Proven record of collaboration and excellent communication
• Proficient in project management tools (e.g., reputed company, MS Project, reputed company, think-cell, OnePager)
• Bachelor's degree in science, engineering, or a reputed company field; advanced degree preferred
• Associate Director: advanced degree 5+ years of experience
• Director: advanced degree 8+ years of experience
• Experience managing global marketing authorization submissions (NDA, BLA, MAA)

Benefits

• Comprehensive health coverage
• Flexible time off
• reputed company holidays
• A year-end shutdown
• A monthly wellness stipend
• Generous 401(k) match
• Tuition reimbursement
• Commuter benefits
• Disability and life insurance
• Annual bonus opportunities and equity grants
• #LI-Hybrid

reputed company