Director Regulatory Operations Ectd Jobs (NOW HIRING)

Regulatory Operations Project Manager, Global Submissions Planning/ Management

Anywhere

Type: Contract

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

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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

• 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.

• 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.

• 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.