Eliassen Group
Eliassen Group

Regulatory Operations Project Manager, Global Submissions Planning/ Management

Remote • Posted 7 hours ago • Updated 7 hours ago
Contract W2
Remote
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Job Details

Skills

  • Lifecycle Management
  • Partnership
  • Life Insurance
  • Regulatory Compliance
  • NDA
  • Marketing
  • Pharmaceutics
  • Management
  • Veeva
  • RIM
  • Project Management
  • Presentations
  • Teamwork
  • Adaptability
  • Publishing
  • Collaboration
  • Chemistry
  • Biology
  • Pharmacy
  • Screening
  • Artificial Intelligence
  • Recruiting
  • Taxes
  • Insurance
  • Law
  • Communication
  • Gmail
  • Routing
  • Management Consulting
  • Life Sciences
  • SAP BASIS
  • Military

Summary

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.


Recruitment Transparency Notice



Eliassen Group values transparency in our recruitment practices. Please be advised that Eliassen Group utilizes artificial intelligence (AI) tools as part of its initial application screening and hiring process. You may receive email and SMS notifications from the Eliassen Virtual Recruiting 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. All AI-assisted evaluations and responses are reviewed by human recruiters before any hiring decisions are made. The use of AI in our process is intended to support fairness, efficiency, and consistency, and Eliassen Group takes measures to prevent bias or discrimination in connection with its hiring practices. By proceeding, you acknowledge, agree, and consent to Eliassen Group'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 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 .

About Eliassen Group:

Eliassen Group is a strategic consulting firm that helps organizations reach further and achieve 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' capacity and accelerate meaningful outcomes. We are driven by a purpose to positively impact the lives of our employees, clients, consultants, and the communities we serve.

Eliassen is committed to building a diverse and inclusive team from a variety of backgrounds, perspectives, and skills. We are an Equal Opportunity and Affirmative Action Employer and all employment decisions are based on merit, performance, and business needs. Eliassen does not discriminate on the basis of race, color, gender identity or expression, sexual preference or orientation, sex (including pregnancy, childbirth, and related medical conditions), marital status, creed, religion, physical or mental disability, genetic information, military or veteran status, age, ancestry, national origin, 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 check!
Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.
  • Dice Id: cxelisen
  • Position Id: a1WUQ000001pzs52AA
  • Posted 7 hours ago

Company Info

About Eliassen Group

Eliassen Group is a leading strategic consulting company that provides business and IT services for our clients as they seek to transform and execute strategies that will drive exceptional outcomes. Leveraging over 30 years of success, we focus on professional services, talent solutions, and life sciences. Eliassen Group offers local community presence and deep networks. We are committed to positively impacting the lives of our employees, clients, consultants, and the communities in which we operate.

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.

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