At a Glance
- Tasks: Support global regulatory submissions and ensure compliance with quality standards.
- Company: Join ProductLife Group, a leader in pharmaceutical manufacturing.
- Benefits: Competitive salary, long-term project visibility, and remote work options.
- Other info: Dynamic role with opportunities for growth and collaboration in a remote setting.
- Why this job: Make an impact in a global environment while developing your career in regulatory affairs.
- Qualifications: Bachelor's degree in Life Sciences and 3+ years in Regulatory Affairs.
The predicted salary is between 64000 - 94000 $ per year.
Overview
This range is provided by Product Life Group.
Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.
Base pay range: $64,000.00/yr - $94,000.00/yr.
The Publishing Officer will support regulatory submission publishing activities for global markets as part of the IPSEN Publishing project.
The role focuses on the preparation, compilation, and publishing of regulatory submissions in multiple electronic formats, ensuring compliance with regional regulatory authority requirements and internal quality standards.
This is a replacement role with long-term project visibility (3+ years) and offers the opportunity to work in a global regulatory environment.
Key Responsibilities
- Perform regulatory publishing activities in e CTD, Nee S, e Paper, and ACTD formats.
- Support submissions across EU, US, Canada, Australia, GCC, ASEAN, and other global regions.
- Compile, publish, and validate regulatory submissions in line with health authority requirements.
- Ensure accuracy, consistency, and technical compliance of published submissions.
- Coordinate and plan assigned publishing projects in collaboration with internal stakeholders.
- Perform quality checks and address validation findings prior to submission.
- Maintain submission documentation and ensure proper version control.
- Work effectively within defined timelines while managing multiple submissions.
- Required Qualifications
- Bachelor's degree in Life Sciences or a related discipline.
- 3+ years of experience in Regulatory Affairs / Regulatory Operations with hands-on e CTD publishing exposure.
- Experience working on international, EU, and Ro W submissions.
- Mandatory
- Technical Skills
- Experience with e CTD and Nee S publishing.
- Strong knowledge of electronic document management systems (e DMS).
- PDF preparation and editing using Adobe Acrobat Pro.
Desirable
- Hands-on experience with Docu Bridge (preferred).
- Familiarity with ISI Toolbox / Evermap (bookmarks, hyperlinks, TOC creation).
- Basic understanding of Regulatory Affairs processes and submission lifecycle.
- Soft Skills & Competencies
- Highly organized and methodical approach to work.
- Strong attention to detail and quality mindset.
- Ability to manage priorities and work under tight timelines.
- Adaptable and comfortable working in a global, remote environment.
- Clear communication and collaboration skills.
- Seniority level
- Executive
- Employment type
- Full-time
- Job function
- Other
- Industries
- Pharmaceutical Manufacturing
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Publishing Officer in Ottawa employer: ProductLife Group
At ProductLife Group, we pride ourselves on being an exceptional employer that fosters a collaborative and innovative work culture. As a Publishing Officer, you will benefit from long-term project visibility in a global regulatory environment, with ample opportunities for professional growth and development. Our commitment to employee well-being is reflected in competitive compensation, a supportive team atmosphere, and the chance to make a meaningful impact in the pharmaceutical industry.
