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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 Senior Manager

Princeton, NJ • On-site

Navitas Life Sciences
Scientific Research and Development Services • 501 - 1,000 employees
Learn more about Navitas Life Sciencesexternal

Full-time

Re-posted 7 days ago

Job description

Job Description
We are currently seeking a Senior Manager of Regulatory Operations. Within the role you will:
  • Develop and execute novel drug regulatory strategy
  • Develop and manage day-to-day operations through the use of project management and planning tools, create and maintain detailed project timelines
  • Establish sound regulatory advice/position on key development issues, and communicate same to the respective stakeholders
  • Provide a high-level review of client programs and develop strategic plans for clinical, analytical, and process development
  • Ensure development programs are compliant with ICH regulatory requirements and all local country regulatory requirements
  • Initiate, author, and/or collaborate on SOP's, work instructions and Work Flows for the regulatory operations function. e.g. electronic Common Technical Document (eCTD) Investigational and Marketing Applications, and post-marketing compliance maintenance submissions in the United States, Europe, and RoW
  • Author clear and concise regulatory documents (CMC authoring) with oversight of all documents for regulatory submissions and associated messaging
  • Work closely with the development team to ensure overall regulatory strategy, regulatory CMC strategy, and labeling strategy for Pharmaceutical/Biological products are aligned
  • Be the point of contact between the company and the regulatory agency - serve as the regulatory liaison
  • Help strategize a road map for EU expansion: MAA planning (Type of submissions - DCP, CP, NP, MRP, Country(ies) selection for MAA and for being CMS vs. RMS and Inputs to set up EU QPPV Office

Desirable Skills and Experience
  • 10 - 15 years' experience working in a regulated, life science environment
  • Strong project management skills
  • Good interpersonal skills
  • Business development skills
  • Experience in defining organizational strategy, process and change management, KPIs and metrics, resource forecasting
  • Extensive knowledge of global submission standards, including but not limited to FDA, HC, EMA, ICH, eCTD and industry trends for dossier preparation (IND/CTA/NDA/MAA/NDA) and regulatory change management and operations.
  • Knowledge on RoW markets is a plus
  • Experience in medical device regulations is a plus
  • Knowledge of eCTD publishing systems, TRS toolbox, and related tools
  • Sound understanding of regulatory information management concepts and tools needed to perform regulatory operations priorities in support of all business areas

Apply