Regulatory Operations Project Manager, Global Submissions Planning/ Management
Anywhere
Category: Q&R
Industry: Life Sciences
Workplace Type: Remote
Reference ID: JN -082026-108288
Date Posted: 08/16/2026
Shortcut: http://careers.eliassen.com/N4Y9xx
Description:
Remote
Our client seeks a Regulatory Operations Project Manager to lead 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 Operations Clinical and Publishing for Global Submissions and may assist with secondary publishing needs as workload demands.
Due to client requirements, applicants must be willing and able to work on a w2 basis. For our w2 consultants, we offer a great benefits package that includes Medical, Dental, and Vision benefits, 401k with company matching, and life insurance.
Rate: $65.00 to $75.00/hr. w2
Responsibilities:
- Serve as the regulatory operational lead for registration planning and execution, including planning sessions, status updates, team operations meetings, and department planning.
- Lead registration management by applying expertise in electronic submission regulations, guidance, and technical content for global submissions across all 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 regions 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 timely, 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 drive 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 direct regulatory experience in pharma with strong clinical Regulatory Operations background.
- Proven global eCTD submission planning and management experience across Modules 1-5 and regions including US, EU, and Canada, with working knowledge of ICH guidelines.
- Experience with Veeva Vault 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 provide secondary publishing support for eCTD submissions when required.
- Ability to work a standard 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 chemistry, biology, or pharmacy.
Skills, experience, and other compensable factors will be considered when determining pay rate. The pay range provided in this posting reflects a W2 hourly rate; other employment options may be available that may result in pay outside of the provided range.
W2 employees of Eliassen Group who are regularly scheduled to work 30 or more hours per week are eligible for the following benefits: medical (choice of 3 plans), dental, vision, pre-tax accounts, other voluntary benefits including life and disability insurance, 401(k) with match, and sick time if required by law in the worked-in state/locality.
If anyone reaches out to you about an open position connected with Eliassen Group, please ensure that you are working directly with us by confirming the following:
· When you work with Eliassen Group, all email communication will come from an Eliassen.com address, never Gmail, Yahoo, etc.
· Eliassen Group will never ask you for personal information (home address, bank account, or check routing number) until you have worked with someone clearly associated with Eliassen Group.
If you have any indication of fraudulent activity, please contact fraud@eliassen.com.
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Eliassen Group is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, pregnancy, sexual orientation, gender identity, national origin, age, protected veteran status, or disability status. Eliassen Group’s Affirmative Action Plan (AAP) is available for inspection by any employee or applicant for employment upon request, during normal business hours of Monday through Friday, 8:30am to 5:30pm EST. Interested persons should contact Phaedra Wells at pwells@eliassen.com for assistance. It is unlawful in Massachusetts and Maryland to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
Applicants with disabilities that believe they require an accommodation or assistance with a position, please email our HR team at hradmin@eliassen.com. This email inbox is designed exclusively to assist job seekers whose disability prevents them from being able to apply online. Emails sent for other purposes will not receive a response.
Please be advised that a number of fraudulent job postings have been released under the Eliassen Group brand.
Unfortunately, fraudulent job postings can happen. If anyone reaches out to you about an open position connected with Eliassen Group, never provide personal or financial information to anyone who is not clearly associated with Eliassen Group
If anyone seemingly from Eliassen Group has ever requested this personal information in the past or does so in the future, please contact fraud@eliassen.com.
Please ensure that you are working directly with us by confirming the following:
- When you work with Eliassen Group, all email communication will come from an Eliassen.com address, never Gmail, Yahoo, etc.
- Eliassen Group will never ask you for personal information (home address, bank account, or check routing number) until you have worked with someone clearly associated with Eliassen Group, as indicated above