We are currently seeking a Senior Manager of Regulatory Operations. Within the role you will ... Knowledge of eCTD publishing systems, TRS toolbox, and related tools * Sound understanding of ...
We are currently seeking a Senior Manager of Regulatory Operations. Within the role you will ... Knowledge of eCTD publishing systems, TRS toolbox, and related tools * Sound understanding of ...
... management, and eCTD-compliant publishing workflows. Collaborate with Regulatory Affairs ... As an experienced CARA Managed Services Senior Consultant you will have the ability to share new ...
... management, and eCTD-compliant publishing workflows. Collaborate with Regulatory Affairs ... As an experienced CARA Managed Services Senior Consultant you will have the ability to share new ...
... management, and eCTD-compliant publishing workflows. Collaborate with Regulatory Affairs ... As an experienced CARA Managed Services Senior Consultant you will have the ability to share new ...
... management, and eCTD-compliant publishing workflows. Collaborate with Regulatory Affairs ... As an experienced CARA Managed Services Senior Consultant you will have the ability to share new ...
... management, and eCTD-compliant publishing workflows. Collaborate with Regulatory Affairs ... As an experienced CARA Managed Services Senior Consultant you will have the ability to share new ...
... management, and eCTD-compliant publishing workflows. Collaborate with Regulatory Affairs ... As an experienced CARA Managed Services Senior Consultant you will have the ability to share new ...
... management, and eCTD-compliant publishing workflows. Collaborate with Regulatory Affairs ... As an experienced CARA Managed Services Senior Consultant you will have the ability to share new ...
... management, and eCTD-compliant publishing workflows. Collaborate with Regulatory Affairs ... As an experienced CARA Managed Services Senior Consultant you will have the ability to share new ...
... management, and eCTD-compliant publishing workflows. Collaborate with Regulatory Affairs ... As an experienced CARA Managed Services Senior Consultant you will have the ability to share new ...
... management, and eCTD-compliant publishing workflows. Collaborate with Regulatory Affairs ... As an experienced CARA Managed Services Senior Consultant you will have the ability to share new ...
... management, and eCTD-compliant publishing workflows. Collaborate with Regulatory Affairs ... As an experienced CARA Managed Services Senior Consultant you will have the ability to share new ...
... management, and eCTD-compliant publishing workflows. Collaborate with Regulatory Affairs ... As an experienced CARA Managed Services Senior Consultant you will have the ability to share new ...
... management, and eCTD-compliant publishing workflows. Collaborate with Regulatory Affairs ... As an experienced CARA Managed Services Senior Consultant you will have the ability to share new ...
... management, and eCTD-compliant publishing workflows. Collaborate with Regulatory Affairs ... As an experienced CARA Managed Services Senior Consultant you will have the ability to share new ...
... management, and eCTD-compliant publishing workflows. Collaborate with Regulatory Affairs ... As an experienced CARA Managed Services Senior Consultant you will have the ability to share new ...
... management, and eCTD-compliant publishing workflows. Collaborate with Regulatory Affairs ... As an experienced CARA Managed Services Senior Consultant you will have the ability to share new ...
... management, and eCTD-compliant publishing workflows. Collaborate with Regulatory Affairs ... As an experienced CARA Managed Services Senior Consultant you will have the ability to share new ...
... management, and eCTD-compliant publishing workflows. Collaborate with Regulatory Affairs ... As an experienced CARA Managed Services Senior Consultant you will have the ability to share new ...
... management, and eCTD-compliant publishing workflows. Collaborate with Regulatory Affairs ... As an experienced CARA Managed Services Senior Consultant you will have the ability to share new ...
... management, and eCTD-compliant publishing workflows. Collaborate with Regulatory Affairs ... As an experienced CARA Managed Services Senior Consultant you will have the ability to share new ...
... management, and eCTD-compliant publishing workflows. Collaborate with Regulatory Affairs ... As an experienced CARA Managed Services Senior Consultant you will have the ability to share new ...
... management, and eCTD-compliant publishing workflows. Collaborate with Regulatory Affairs ... As an experienced CARA Managed Services Senior Consultant you will have the ability to share new ...
... management, and eCTD-compliant publishing workflows. Collaborate with Regulatory Affairs ... As an experienced CARA Managed Services Senior Consultant you will have the ability to share new ...
... management, and eCTD-compliant publishing workflows. Collaborate with Regulatory Affairs ... As an experienced CARA Managed Services Senior Consultant you will have the ability to share new ...
... management, and eCTD-compliant publishing workflows. Collaborate with Regulatory Affairs ... As an experienced CARA Managed Services Senior Consultant you will have the ability to share new ...
... management, and eCTD-compliant publishing workflows. Collaborate with Regulatory Affairs ... As an experienced CARA Managed Services Senior Consultant you will have the ability to share new ...
... management, and eCTD-compliant publishing workflows. Collaborate with Regulatory Affairs ... As an experienced CARA Managed Services Senior Consultant you will have the ability to share new ...
... management, and eCTD-compliant publishing workflows. Collaborate with Regulatory Affairs ... As an experienced CARA Managed Services Senior Consultant you will have the ability to share new ...
Managed Services Sr. Consultant
Omaha, NE · On-site
... management, and eCTD-compliant publishing workflows. Collaborate with Regulatory Affairs ... As an experienced CARA Managed Services Senior Consultant you will have the ability to share new ...
Managed Services Sr. Consultant
Omaha, NE · On-site
... management, and eCTD-compliant publishing workflows. Collaborate with Regulatory Affairs ... As an experienced CARA Managed Services Senior Consultant you will have the ability to share new ...
... management, and eCTD-compliant publishing workflows. Collaborate with Regulatory Affairs ... As an experienced CARA Managed Services Senior Consultant you will have the ability to share new ...
... management, and eCTD-compliant publishing workflows. Collaborate with Regulatory Affairs ... As an experienced CARA Managed Services Senior Consultant you will have the ability to share new ...
... management, and eCTD-compliant publishing workflows. Collaborate with Regulatory Affairs ... As an experienced CARA Managed Services Senior Consultant you will have the ability to share new ...
... management, and eCTD-compliant publishing workflows. Collaborate with Regulatory Affairs ... As an experienced CARA Managed Services Senior Consultant you will have the ability to share new ...
Managed Services Sr. Consultant
Tempe, AZ · On-site
... management, and eCTD-compliant publishing workflows. Collaborate with Regulatory Affairs ... As an experienced CARA Managed Services Senior Consultant you will have the ability to share new ...
Managed Services Sr. Consultant
Tempe, AZ · On-site
... management, and eCTD-compliant publishing workflows. Collaborate with Regulatory Affairs ... As an experienced CARA Managed Services Senior Consultant you will have the ability to share new ...
Managed Services Sr. Consultant
Boise, ID · On-site
... management, and eCTD-compliant publishing workflows. Collaborate with Regulatory Affairs ... As an experienced CARA Managed Services Senior Consultant you will have the ability to share new ...
Managed Services Sr. Consultant
Boise, ID · On-site
... management, and eCTD-compliant publishing workflows. Collaborate with Regulatory Affairs ... As an experienced CARA Managed Services Senior Consultant you will have the ability to share new ...
Senior Ectd Publisher information
What is the difference between Senior Ectd Publisher vs Ectd Publisher?
| Aspect | Senior Ectd Publisher | Ectd Publisher |
|---|---|---|
| Credentials | Typically requires experience in eCTD publishing, life sciences, and related certifications | Requires similar experience and certifications, but less leadership responsibility |
| Work Environment | Works in pharmaceutical or biotech companies, often in regulatory teams | Similar environment, often as part of regulatory or publishing teams |
| Responsibilities | Leads publishing projects, mentors junior staff, ensures compliance | Performs publishing tasks, supports project needs, follows established procedures |
The main difference between a Senior Ectd Publisher and an Ectd Publisher is the level of responsibility. Senior roles typically involve leadership, mentorship, and project oversight, while Ectd Publishers focus on executing publishing tasks. Both roles require similar qualifications and work in comparable environments within the pharmaceutical and biotech industries.
What are some common challenges Senior eCTD Publishers face when managing multiple regulatory submissions simultaneously?
Senior eCTD Publishers often juggle several regulatory submissions at once, each with unique timelines, formatting requirements, and jurisdictional regulations. Coordinating with various cross-functional teams—such as regulatory affairs, clinical, and quality assurance—can add complexity, especially when gathering final documents and resolving last-minute changes. Effective time management, meticulous attention to detail, and strong communication skills are essential to ensure all submissions are compliant, accurate, and delivered on time.
What are Senior eCTD Publishers?
Senior eCTD Publishers are specialized professionals in the pharmaceutical and biotechnology industries who are responsible for preparing, compiling, and submitting electronic Common Technical Document (eCTD) submissions to regulatory agencies like the FDA and EMA. They ensure that all documents and data meet strict regulatory requirements for format, structure, and quality. In addition to technical publishing tasks, they often lead submission projects, coordinate with cross-functional teams, and provide expertise in regulatory submission standards and software tools.
What are the key skills and qualifications needed to thrive as a Senior eCTD Publisher, and why are they important?
To thrive as a Senior eCTD Publisher, you need in-depth knowledge of regulatory submissions, eCTD structure, and relevant industry guidelines, typically backed by experience in regulatory affairs or pharmaceutical publishing. Proficiency with eCTD publishing software (such as Lorenz DocuBridge or Extedo), document management systems, and familiarity with FDA/EMA submission portals is essential. Attention to detail, strong organizational skills, and effective communication help ensure accuracy and collaboration within cross-functional teams. These skills and qualifications are vital for ensuring compliant, timely, and error-free submissions to regulatory authorities.
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Full-time
Re-posted 8 days ago
Job description
Job Description
We are currently seeking a Senior Manager of Regulatory Operations. Within the role you will:
Desirable Skills and Experience
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
About Navitas Life Sciences
Sourced by ZipRecruiter
Industry
Scientific research and development services
Company size
501 - 1,000 Employees
Headquarters location
Princeton, NJ, US
Year founded
2001