Regulatory Submission Publishing Specialist

About the role

Coordinate the submission and publishing process for regulatory registrations, primarily for the US and EU markets. This is a remote, part-time contract position based in Pleasanton, CA, offering flexible days and 24-32 hours per week.

Responsibilities

• 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.

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.

Pay

$23.46 - $34.98 per hour.

Schedule

Part-time, 24-32 hours per week with flexible days.

Benefits

• Health and welfare benefits coverage options including medical, dental, and vision.
• Spending accounts and life insurance.
• Voluntary plans and participation in a 401(k) plan.