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Regulatory Publishing Specialist
5 days agoWhat's your preference?
Job Description
- Req#: R-01337181
Employer Industry: Pharmaceutical Regulatory Services
Why consider this job opportunity:
- Opportunity for career advancement and growth within the organization
- Work in a collaborative environment that values innovation
- Engage with top pharmaceutical companies and biotechs on significant projects
- Contribute to the success of regulatory submissions and compliance
- Chance to enhance your skills in document management and electronic submissions
What to Expect (Job Responsibilities):
- Coordinate and manage client electronic submission deliverables supporting regulatory compliance
- Assist in preparing electronic document outputs that meet regulatory publishing requirements
- Ensure final electronic deliverables comply with current regulatory document requirements
- Develop and implement project-specific processes for unique technology requirements
- Evaluate publishing needs in relation to project timelines, quality, and delivery
What is Required (Qualifications):
- Bachelor's degree or equivalent and relevant formal academic/vocational qualification
- Minimum of 2 years of experience in regulatory publishing or a related field
- Strong knowledge of regulatory requirements for document management and electronic submissions
- Proficiency in Microsoft Word, Excel, Adobe Acrobat, and electronic document management systems
- Strong organizational skills and effective interpersonal skills
How to Stand Out (Preferred Qualifications):
- Experience with document publishing tools and eCTD validation/viewing tools
- Knowledge of medical terminology and FDA regulatory guidelines
- Strong editorial and proofreading skills
- Ability to manage multiple complex projects simultaneously
- Familiarity with statistical concepts related to regulatory submissions
#PharmaceuticalIndustry #RegulatoryAffairs #CareerOpportunities #DocumentManagement #InnovationInPublishing
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