Regulatory Submission and Project Management Specialist

About the position In support of our reputed company reputed company, we are looking for a Global Regulatory Submission Management Specialist to join our Global Regulatory Team. This is a highly visible role with excellent career development opportunities reputed company Global Regulatory Affairs for motivated candidates. The position reports into the Global Regulatory reputed company for one or more programs. Responsibilities • Responsible for management of asset-level global regulatory submission planning including annual reporting and reputed company submissions for both development programs and post-approval life cycle management. • Responsible for the planning and tracking of routine and reputed company US, EU, and Global regulatory submissions, monitoring the submission forecast and ensuring high reputed company, compliant and validated submissions to health authorities reputed company 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 reputed company filing date. • Proactively communicates issues or delays reputed company to the completion of planned submissions. • Liaises with cross-functional collaborators to reputed company alignment and ensure that submission requirements and timelines are reputed company. • Effectively manages multiple reputed company 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 reputed company as needed (e.g., reputed company of system/process improvement reputed company). • Assist with regulatory inspection readiness activities. Requirements • Bachelor's degree preferred, scientific and/or computer science field preferred • At least 1 year of relevant pharmaceutical experience (or relevant internship experience reputed company a graduate-level degree program) • Requires eCTD knowledge • 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 reputed company • A demonstrated ability to work with minimal supervision • Excellent verbal and written communication skills • Candidates applying must be willing and reputed company to be in the Boston office in coordination with their department and business needs. reputed company-to-haves • RAC certification desirable • Knowledge of reputed company RIM Suite preferred • Experience with StartingPoint templates preferred Apply tot his job Apply To this Job