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How much do regulatory operations ectd jobs pay per hour?

As of Sep 12, 2026, the average hourly pay for regulatory operations ectd in the United States is $21.30, according to ZipRecruiter salary data. Most workers in this role earn between $16.83 and $24.28 per hour, depending on experience, location, and employer.

What is a Regulatory Operations eCTD specialist?

Regulatory Operations eCTD roles involve managing the electronic submission of regulatory documents to health authorities using the electronic Common Technical Document (eCTD) format. Professionals in these roles coordinate the compilation, publishing, validation, and submission of complex regulatory files to ensure compliance with global regulations. They work closely with regulatory affairs, document management, and IT teams to maintain submission readiness and support the lifecycle of pharmaceutical product registrations.

What are the key skills and qualifications needed to thrive as a Regulatory Operations eCTD specialist?

To thrive as a Regulatory Operations eCTD Specialist, you need expertise in regulatory submission processes, knowledge of electronic Common Technical Document (eCTD) requirements, and usually a background in life sciences or regulatory affairs. Familiarity with eCTD publishing tools (such as Lorenz DocuBridge or Extedo), regulatory information management systems, and relevant certifications like RAPS is highly beneficial. Attention to detail, strong organizational skills, and effective communication are essential soft skills for managing complex documentation and collaborating with cross-functional teams. These skills ensure timely and compliant submission of regulatory documents, which is critical for successful product approvals and ongoing regulatory compliance.

What are some typical challenges faced by professionals working in Regulatory Operations eCTD, and how can they be addressed?

Professionals in Regulatory Operations eCTD often encounter challenges such as managing tight submission deadlines, staying updated with evolving global regulatory requirements, and ensuring the accuracy and completeness of complex electronic submissions. To address these challenges, it is important to develop strong project management skills, maintain open communication with cross-functional teams, and regularly participate in training on new eCTD standards and tools. Leveraging robust document management systems and staying proactive in monitoring regulatory updates can also help streamline the submission process and reduce errors.

What are popular job titles related to Regulatory Operations Ectd jobs?

For Regulatory Operations Ectd jobs, the most frequently searched job titles are:

Infographic showing various Regulatory Operations Ectd job openings in the United States as of August 2026, with employment types broken down into 88% Full Time, 11% Part Time, and 1% Contract. Highlights an 94% Physical, 2% Hybrid, and 4% Remote job distribution, with an average salary of $44,307 per year, or $21.3 per hour.

Regulatory Operations Project Manager, Global Submissions Planning/ Management

Almont, CO • On-site

Eliassen Group
IT Services • 5 - 10K employees
Learn more about Eliassen Groupexternal

$65 - $75/hr

Other

Medical, Dental, Vision, Life, Retirement

Posted 25 days ago

Job description

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!
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About Eliassen Group

Sourced by ZipRecruiter

Eliassen Group provides strategic consulting and talent solutions to drive our clients' innovation and business results. Our purpose is to positively impact the lives of our employees, clients, consultants, and the communities in which we operate. Leveraging over 30 years of success, our expertise in talent solutions, life sciences consulting, Agile consulting, cloud services, risk management, business optimization, and managed services enables us to partner with our clients to execute their business strategy and scale effectively. Headquartered in Reading, MA, and with offices from coast to coast, Eliassen Group offers local community presence and deep networks, as well as national reach.

Industry

It services

Company size

5,001 - 10,000 Employees

Headquarters location

Reading, MA, US

Year founded

1989

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