Job Description
Regulatory Submission Publishing Specialist
Location: 4300 Hacienda Drive Pleasanton CA USA 94588
Duration: 1 Year (Potential for Extension or Conversion)
Pay Rate: $24.16-$36.02/hr(W2) Based On experience
Benefits: Weekly pay, Medical, Dental, and Vision coverage
Work Model: Remote(Flexible days, part time (24-32 hours/week))
Summary:
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.
Job Duties:
Requirements
Qualifications:
Location: 4300 Hacienda Drive Pleasanton CA USA 94588
Duration: 1 Year (Potential for Extension or Conversion)
Pay Rate: $24.16-$36.02/hr(W2) Based On experience
Benefits: Weekly pay, Medical, Dental, and Vision coverage
Work Model: Remote(Flexible days, part time (24-32 hours/week))
Summary:
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.
Job Duties:
- 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
- Soft 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
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.
Numbers & Facts
| Location | Pleasanton, CA |
| Industry | Staffing/Employment Agencies |
| Salary | $24.16–$36.02 Per Hour |
| Company Size | 1,000 to 1,499 employees |
| Year Founded | 1968 |
| Website | https://www.tailoredmanagement.com/ |
About Company
CONNECTING TOP TALENT WITH TOP-TIER OPPORTUNITIES
Tailored Management is a global staffing firm that specializes in partnering with large organizations that run their contingent labor program in a VMS/MSP environment. We have the unique capacity to support programs across all scopes and geographic locations from a single headquarters, successfully elevating program performance across the board and minimizing costs, miscommunication and delivery times. But what do we really do? We bring together the best talent with the greatest opportunities.