Regulatory Submission Publishing Specialist

Reference: 629952Posted: 2026-08-10Location: Pleasanton, CACompany: Planet Pharma GroupContact: ApplicationsEmail: View email address on click.appcast.io: We are seeking a Regulatory Submission Publishing Specialist to join our Diagnostics Regulatory Affairs team. The ideal candidate will manage and facilitate the preparation, submission, and publishing process of regulatory submissions intended for registration purposes, primarily in the US or EU.Key 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.Qualifications:

• BA in Life Sciences, Regulatory Science, Quality, or related field.
• Proven experience in preparing compliant regulatory submissions in the

diagnostics or pharmaceutical sector.

• Strong attention to detail and organizational skills.
• Excellent written and verbal communication skills.
• Proficiency with industry-standard publishing and submission software and tools.
• 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.Preferred: * Proficiency with industry standard publishing and submission software and tools (Microsoft Word, Acrobat Pro, ISI Toolbox, Veeva RIMS, US Health Authority portals)

• Previous experience in a diagnostics, pharmaceutical, or biotech company. RequirementsSoft skills:
• Strong attention to detail and organizational skills.
• Excellent written and verbal communication skills.
• Proficiency with publishing and submission software and tools.
• Ability to manage multiple projects and meet deadlines in a fast-paced environment.Hard/technical skills* Proficiency with industry standard publishing and submission software and tools (Microsoft Word, Acrobat Pro, ISI Toolbox, US Health Authority portals)
• Ability to navigate standard business applications (Gmail, Chat, DMS, Veeva RIMS, and other business applications).
• Minimum years of experience: 5 years
• Education requirements: BA, or equivalent professional experience???????Pay Range: 30-36/hr