Regulatory Submission Publishing Specialist

Liaise with project leads, project teams, and regulatory bodies to gather necessary documents and ensure smooth submission processes. System One, and its subsidiaries including Joulé and Mountain Ltd., are leaders in delivering outsourced services and workforce solutions across North America.

Job Title: Regulatory Submission Publishing Specialist
Location: Pleasanton, CA
Type: Contract
Compensation: $23.46 - $34.98
Work Model: Remote – offsite
Hours: Flexible days, part time (24-32 hours/week)
Security Clearance: Not specified

Responsibilities

• Coordinate the submission and publishing process for regulatory registrations, primarily for the US and EU markets.
• Prepare submissions in accordance with external health authority guidelines, and internal standard practices.
• Prepare and format documents according to publication and submission requirements.
• Liaise with project leads, project teams, and regulatory bodies to gather necessary documents and ensure smooth submission processes.
• Maintain tracking systems to monitor the status and deadlines of all submissions.
• Support the management of publication databases and repositories.
• Collaborate with Regulatory Leads and Managers to ensure submission deliverables meet requirements are fulfilled.

Requirements

• Minimum of 5 years of experience in regulatory submissions within the diagnostics or pharmaceutical sector.
• Bachelor’s degree in Life Sciences, Regulatory Science, Quality, or related field, or equivalent professional experience.
• Strong attention to detail and organizational skills.
• Excellent written and verbal communication skills.
• Proficiency with industry-standard publishing and submission software and tools (Microsoft Word, Acrobat Pro, ISI Toolbox, Veeva RIMS, US Health Authority portals).
• Ability to manage multiple projects and meet deadlines in a fast-paced environment.
• Familiarity with regulatory guidelines such as FDA, EMA, ICH, GxP, and publication ethics.

System One, and its subsidiaries including Joulé and Mountain Ltd., are leaders in delivering outsourced services and workforce solutions across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.

System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.

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