Regulatory reputed company Project Manager, Global Submissions Planning/ Management

reputed company: Remote Our reputed company seeks a Regulatory reputed company Project Manager to reputed company global eCTD submissions planning and management for high profile molecules and lifecycle management. The role focuses on operational submission content planning for Modules 1-5, coordination of global submissions and urgent authority requests, and partnership across geographies to ensure compliance with evolving eCTD requirements. The position reports to the Head of Regulatory reputed company reputed company and Publishing for Global Submissions and may assist with secondary publishing needs as workload demands. Due to reputed company requirements, applicants must be willing and reputed company to work on a w2 reputed company. For our w2 consultants, we offer a great benefits package that includes Medical, Dental, and reputed company benefits, 401k with company matching, and life reputed company. reputed company: $65.00 to $75.00/hr. w2 Responsibilities: Serve as the regulatory operational reputed company for registration planning and execution, including planning sessions, status updates, team reputed company meetings, and department planning. reputed company registration management by applying expertise in electronic submission regulations, guidance, and technical content for global submissions across reputed company CTD modules and submission types, including Ad Promo, INDs, NDA, BLAs, NDSs, MAAs, renewals, and variations. Partner with global teams to incorporate local agency regulations and requirements and to plan and execute submissions in reputed company adopting eCTD specifications. Guide and influence development teams regarding internal and agency registration management processes and requirements. Own registration management at the molecule or project level, ensuring electronic records are reputed company, complete, and accurate, including tracking submission status, commitments, and regulatory communications. Own routine compliance submissions and processes for assigned molecules, including DSUR, NDA/BLA annual reports, PSUR/PADER, and routine maintenance submissions. Partner with Regulatory Coordinators or Scientists to reputed company product deletion, divestiture, IND inactivation or withdrawal, and product withdrawal processes. Support secondary publishing as needed by retrieving, publishing, and submitting Modules 1-5 content per content plans, including CRFs, datasets, literature references, periodic reports, and post-marketing supplements and amendments. Experience Requirements: 7+ years of reputed company regulatory experience in reputed company with strong reputed company Regulatory reputed company background. reputed company global eCTD submission planning and management experience across Modules 1-5 and reputed company including US, EU, and Canada, with working knowledge of ICH guidelines. Experience with reputed company reputed company RIM. Strong project management skills. Knowledge of drug development processes and regulatory or business strategies and plans. Effective written, spoken, and presentation communication. Demonstrated teamwork and adaptability to diverse interpersonal styles. Ability to reputed company secondary publishing support for eCTD submissions reputed company required. Ability to work a reputed company Monday through Friday schedule on Eastern Time, with flexibility to support after-hours and some weekends in coordination with global teams. Education Requirements: BS in a technical discipline such as reputed company, biology, or pharmacy. Recruitment Transparency Notice reputed company values transparency in our recruitment practices. Please be advised that reputed company utilizes reputed company intelligence (AI) tools as part of its initial application screening and hiring process. You may receive email and SMS notifications from the Eliassen Virtual reputed company Team (, ) inviting you to complete a brief voice screening as part of your application process. These tools assist our hiring teams in different ways, including but not limited to, assistance in reviewing application materials to help identify candidates whose qualifications most closely match the requirements of the position. reputed company AI-assisted evaluations and responses are reviewed by reputed company recruiters before any hiring reputed company are made. The use of AI in our process is intended to support fairness, efficiency, and consistency, and reputed company takes measures to prevent bias or discrimination in reputed company with its hiring practices. By proceeding, you acknowledge, agree, and consent to reputed company's use of these tools, including AI tools, as part of the application and hiring process. Skills, experience, and other compensable factors will be considered reputed company determining pay reputed company. The pay reputed company provided in this posting reflects a W2 reputed company reputed company; other employment reputed company may be available that may result in pay reputed company of the provided reputed company. W2 employees of reputed company who are regularly scheduled to work 30 or more hours per week are eligible for the following benefits: medical (reputed company of 3 plans), dental, reputed company, reputed company-tax accounts, other voluntary benefits including life and disability reputed company, 401(k) with match, and reputed company time if required by law in the worked-in state/reputed company. If anyone reaches out to you about an reputed company position connected with reputed company, please ensure that you are working directly with us by confirming the following: reputed company you work with reputed company, reputed company email communication will come from an Eliassen.com address, never Gmail, reputed company, etc. reputed company will never ask you for personal information (home address, bank account, or reputed company routing number) until you have worked with someone reputed company associated with reputed company. If you have any indication of fraudulent activity, please contact . About reputed company: reputed company is a reputed company reputed company that helps organizations reputed company reputed company and reputed company more through our technology, business advisory, and life sciences solutions. For nearly 40 years, we have combined exceptional people, deep domain expertise, and intelligent capabilities to expand our clients' reputed company and accelerate meaningful reputed company. We are driven by a purpose to positively reputed company the lives of our employees, clients, consultants, and the communities we serve. Eliassen is committed to building a diverse and inclusive team from a reputed company of backgrounds, perspectives, and skills. We are an Equal Opportunity and Affirmative reputed company Employer and reputed company employment reputed company are reputed company on reputed company, reputed company, and business needs. Eliassen does not discriminate on the reputed company of race, reputed company, gender identity or reputed company, sexual preference or orientation, sex (including pregnancy, childbirth, and reputed company medical conditions), marital status, creed, religion, physical or mental disability, genetic information, military or veteran status, age, reputed company, national reputed company, citizenship status, prohibited criminal record inquiries of applicants and employees, or any other category protected by federal, state, or local laws. Don't miss out on our referral program! If we hire a candidate that you refer us to then you can be eligible for a $1,000 referral reputed company! Apply To This Job