Job Title: Regulatory Affairs Manager II

Location: 100% Remote (EST time zone)

Contract Duration: 12 months

Position Overview:

We are seeking a highly skilled and experienced Regulatory Affairs Manager II to join our team. This is a fully remote position, operating within the Eastern Standard Time (EST) zone. The successful candidate will manage regulatory systems and submissions for client’s product portfolio, collaborating closely with global IT and cross-functional stakeholders.

Key Responsibilities:

• Manage eCTD submission processes across client’s product portfolio to Health Authorities for global development and lifecycle management submissions.
• Oversee outsourced publishing deliverables, ensuring successful execution of operational activities for assigned products.
• Serve as the primary point of contact for regulatory functions throughout the product lifecycle.
• Ensure electronic submissions meet regulatory agency and submission standards and technical requirements.
• Perform quality control checks on electronic common technical (eCTD) components, final submissions, hyperlinks, and bookmarks, ensuring compliance with local health authority guidelines.
• Utilize electronic document management and submissions publishing tools efficiently.

Required Qualifications:

• 3-5 years of experience in regulatory operations, with proficiency in regulatory systems and submissions.
• Demonstrated experience with regulatory systems (e.g., InSight, Veeva, Docubridge, CARA) and a solid understanding of the submissions process.
• Proven ability to draft and review process documents, perform mapping, SOW documentation, and conduct UAT testing.
• Experience collaborating with global IT teams and cross-functional stakeholders to provide training and support for new systems, tools, and applications.
• Deep knowledge of submission or technology-related health authority guidelines and regulations.

Skills:

• Excellent project management and organizational skills.
• Strong communication and stakeholder management abilities.
• Attention to detail and ability to perform quality checks efficiently.
• Proficiency with electronic document management and publishing tools.