**Work Schedule**
Standard (Mon-Fri)
**Environmental Conditions**
Office
**Summarized Purpose**:
Provides moderate, expedient, and efficient preparation of client electronic submission deliverables and
dossier that meet current local, regional and ICH regulatory and technical requirements. Ensures
successful regulatory review outcomes for product milestones. Serves in a quality review role and is
responsible for the thorough review of documents created within or outside of the company to ensure
quality of standards meet or exceed client expectations.
**Essential Functions and Other Job Information**:
**Essential Functions**
Coordinates and manages client electronic submission deliverables supporting
regulatory compliance.
Assists in preparing electronic document outputs that meet requirements for
regulatory publishing to include documents that work with sponsor and/or
regulatory agency software programs meeting consistency and security issues.
Ensures that all final electronic deliverables meet current regulatory electronic
document requirements and guidance under general supervision of the Manager,
Regulatory Publishing and assistance as appropriate from a Senior Regulatory
Publishing Specialist.
Assists with developing and implementing project-specific processes for sponsors
with unique technology requirements and may act as the company's liaison for
electronic submissions with the sponsor.
Exercises judgment within defined procedures and practices to determine
appropriate action.
Evaluates the publishing needs in relationship to the overall project timelines,
quality and delivery.
Engages other project team members, functional units or publishing
management as necessary to deliver final product and resolve/mitigate identified
issues or barriers to delivery.




Acts independently within a project team to evaluate and deliver publishing
tasks.
**Job Complexity**
Works on problems of moderate scope where analysis of situations or data requires
a review of a variety of factors.
**Job Knowledge**
Developing professional expertise, applies company policies and procedures to
resolve a variety of issues.
**Supervision Received**
Normally receives general instructions on routine work, detailed instructions on new
projects or assignments. Exercises judgment within defined procedures and
practices to determine appropriate action.
**Business Relationships**
Contacts are primarily internal to the company with infrequent external customer /
vendor contact on routine matters. Builds productive internal / external working
relationships.
**Qualifications**:
Education and Experience:
Bachelor's degree or equivalent and relevant formal academic / vocational qualification
Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to
2+ years).
- In some cases an equivalency, consisting of a combination of appropriate education, training_
- and/or directly related experience, will be considered sufficient for an individual to meet the_
- requirements of the role._
**Knowledge, Skills and Abilities**:
Working knowledge of regulatory requirements and guidances for document management and
electronic submissions
Strong knowledge of Microsoft (MS)



Word, MS Excel, Adobe Acrobat, electronic document
management systems, document publishing tools, publishing systems, eCTD validation and viewing
tools
Strong knowledge of electronic templates and skilled in formatting and troubleshooting templates
Ability to manage several complex projects in parallel and adapt to changing priorities
Ability to exercise independent judgment in developing methods, techniques and evaluation of criteria
using defined procedures and practices
Ability to independently assess sponsor needs and work with project team members in producing
compliant deliverables
Ability to independently learn new technologies
Strong organizational skills and effective interpersonal skills
Strong analytical ability and problem-solving capabilities
Good working knowledge of medical terminology, statistical concepts, and guidelines and
requirements of the FDA and other international regulatory agencies
Strong editorial/proofreading skills
Detail-oriented, thorough, and methodical
Ability to create and follow timelines and conduct long-range planning
Ability to multitask performing numerous single or complex tasks without ignoring overall objectives
Ability to judge when to initiate changes and make final determinations in the presentation of data in
accordance with regulatory guidelines and reviewers’ comments
Ability to concentrate on the detail in a document without losing sight of the document as a whole
**Management Role**:
No management responsibility
**Working Conditions and Environment**:
Work is performed in an office/ laboratory and/or a clinical environment.
Exposure to biological fluids with potential exposure to infectious organisms.
Exposure to electrical

📌 Reg Publishing Spec (México)
🏢 Thermo Fisher Scientific
📍 México