What You’ll Do:

The Director of Global Regulatory Affairs (Submission Project Management) is responsible for leading regional and global cross-functional teams in the planning, preparation, and delivery of compliant marketing authorization filings. This role combines strategic leadership with hands-on project management to ensure timely and high-quality submissions that support product approvals, lifecycle management, and organizational growth.

Required location: Waltham, MA (hub-based, onsite 3-4 days per week)

Responsibilities:

• Contribute to and lead the execution of submission strategies in alignment with corporate objectives and regulatory requirements
• Provide guidance on evolving global regulatory landscapes, including guidelines, regulations, and other factors related to regulatory filings
• 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
• Liaising with regulatory operations department to ensure all components are identified on the submission content plans and submissions meet technical, formatting, and compliance standards
• Develop and manage marketing authorization project timelines and deliverables
• Identify risks and manage operational risks, implementing mitigation/contingency strategies to ensure submission success
• Track progress and report status updates to executive leadership
• Establish best practices and SOPs as needed for marketing application related submission processes
• Ensure adherence to ICH, FDA, EMA, and other global regulatory regulations/guidelines
• Build strong collaborative relationships across departments

 

Required Qualifications:

• 10+ years (8+ with advanced degree) of regulatory affairs and/or project management experience
• Proven track record managing global submissions (NDA, BLA, MAA)
• Deep expertise in the integrated drug development process, ensuring seamless progression from discovery through commercialization
• Collaborated effectively across multidisciplinary teams to identify innovative solutions and alternatives, driving positive business outcomes
• Expertly assessed and mitigated risk within a highly regulated environment, maintaining compliance while advancing critical projects
• Strong project management skills (PMP certification a plus), with proficiency in Microsoft Project, SmartSheet, or Planisware
• Excellent communication, organizational, and leadership abilities
• Ability to thrive in a fast-paced, deadline-driven environment
• Demonstrated negotiation and influence skills

Preferred Qualifications:

• Experience in international regulatory submissions and regulatory interactions
• Previous regulatory or leadership assignments across multiple countries

Education:

• Bachelor’s degree with regulatory and/or project management experience in the pharmaceutical industry, 
• Advanced degree in Life Sciences, Regulatory Affairs, or related field (PhD, PharmD, MS preferred)