Jobs in Massachusetts 2026 (Now Hiring) - Smart Auto Apply

• Responsible for management of asset-level global regulatory submission planning including annual reporting and ad hoc submissions for both development programs and post-approval life cycle management.
• Responsible for the planning and tracking of routine and ad hoc US, EU, and Global regulatory submissions, monitoring the submission forecast and ensuring high quality, compliant and validated submissions to health authorities within required timelines.
• Manages submission calendar, creates content plans for lifecycle and global submissions across multiple global applications, creates timelines and oversees responsibility matrices through cross-functional discussions, and tracks submission deliverables to maintain the target filing date.
• Proactively communicates issues or delays related to the completion of planned submissions.
• Liaises with cross-functional collaborators to gain alignment and ensure that submission requirements and timelines are understood.
• Effectively manages multiple projects and competing priorities.

• Maintains regulatory trackers for assigned programs, including submission calendar, archives of regulatory submissions, correspondence and commitments.
• May assist in management of special projects as needed (e.g., oversight of system/process improvement projects).
• Assist with regulatory inspection readiness activities.

• Bachelor's degree preferred, scientific and/or computer science field preferred
• At least 1 year of relevant pharmaceutical experience (or relevant internship experience within a graduate-level degree program)
• Requires eCTD knowledge
• RAC certification desirable
• Knowledge of Veeva RIM Suite preferred
• Experience with StartingPoint templates preferred
• Working knowledge of the drug development process
• Solid understanding of regulatory requirements and submission processes
• Excellent collaboration and time management skills; ability to handle multiple work assignments concurrently; ability to coordinate and prioritize conflicting deadlines
• Strong organizational skills with detail-oriented focus
• A demonstrated ability to work with minimal supervision
• Excellent verbal and written communication skills

• We are committed to advancing scientific understanding to improve patients’ lives
• We are inspired to tackle tough challenges and have the courage to ask bold questions
• We are eager to learn and adapt
• We believe collaboration and ownership are foundational for our success
• We value the unique contribution each individual brings to furthering our mission

Powered by JazzHR