Location: Remote Role
Salary Range: $38/hr. on W2
Introduction
We are seeking a highly skilled professional to join our Diagnostics Regulatory Affairs team. This role is critical to managing and optimizing the end-to-end preparation, publishing, and electronic submission of regulatory documents supporting the registration of a diverse portfolio of global diagnostic products. You will oversee compliance with global regulatory frameworks and standards, primarily focusing on US and EU markets, and leverage advanced publishing tools and electronic submission gateways to ensure timely and accurate submissions.
Required Skills & Qualifications
- Bachelor’s degree in Life Sciences, Regulatory Science, Quality Assurance, or related field; advanced degree preferred.
- 5 years’ experience in regulatory submission publishing for diagnostics or related life science areas.
- Strong understanding of FDA, EMA, ICH regulatory standards. Familiarity with global regulatory environments beyond US/EU.
- Excellent organizational and communication skills, with ability to handle multiple deadlines independently.
- Applicants must be able to work directly for Artech on W2.
- Prior work experience at client or in client's Industry.
Preferred Skills & Qualifications
- Experience with AI, RPA, or publishing automation tools is highly preferred.
- Experience in continuous improvement and automation.
- Leadership or mentoring experience is a plus.
Day-to-Day Responsibilities
- Lead the preparation, publishing, and electronic submission of regulatory dossiers for a diverse portfolio of diagnostics products, ensuring accuracy and compliance with regulatory requirements.
- Use platforms like Veeva Vault, LORENZ docuBridge FIVE, or eCTD Xpress for compiling, validating, and publishing submission packages.
- Manage submissions through electronic submission gateways including FDA CCP and ESG, Notified Body portals, and EMA Common Gateway.
- Conduct comprehensive quality control and compliance checks on submissions.
- Oversee submission lifecycle management and sequence planning to align with global regulatory timelines.
- Collaborate closely with cross-functional teams to troubleshoot publishing challenges.
- Manage and maintain regulatory document repositories and publication databases.
- Apply regulatory standards rigorously throughout the publishing and submission lifecycle.
- Drive adoption of new requirements and emerging technologies to enhance publishing efficiency and accuracy.
Company Benefits & Culture
- We value accountability, encouraging ownership and high-quality results.
- Autonomy is key; you will work independently while collaborating across many functional areas and external teams in multiple geographies.
- Our culture champions continuous learning, opportunity, innovation, process improvement, and a steadfast commitment to compliance and excellence.
For immediate consideration please click APPLY to begin the screening process with Alex.
You can share your resumes on satyam.singh@artech.com