Regulatory Affairs Publisher

Title: Regulatory Publishing Specialist

Duration: 6 months to start

Location: REMOTE

Job Overview:

We are seeking a skilled Regulatory Affairs Publishing Contractor with extensive experience in regulatory submissions and a strong background in using Veeva for publishing activities. The ideal candidate will have specialized knowledge in processing safety reports and ensuring compliance with regulatory requirements.

Key Responsibilities:

Manage and execute the publishing of regulatory submissions in accordance with global health authority guidelines and company standards.

Utilize Veeva Vault to compile, publish, and submit regulatory documentation, ensuring accuracy and completeness.

Collaborate closely with cross-functional teams including Regulatory Affairs, Quality Assurance, and Clinical Development to support regulatory submissions and responses.

Provide expertise in the electronic submission requirements and formats (eCTD, NeeS, etc.) as applicable to regulatory filings.

Lead the preparation and submission of safety reports, ensuring timely and compliant processing.

Stay current with regulatory guidelines and industry best practices related to publishing and submissions.

Qualifications:

Bachelor’s degree in a scientific discipline; advanced degree preferred.

Minimum of 5-6 years of experience in Regulatory Affairs, specifically in publishing regulatory submissions.

Proven expertise in using Veeva Vault.

Experience in processing safety reports and familiarity with safety databases (e.g., Argus, ARISg).

Strong understanding of global regulatory requirements and guidelines.

Experience with Docubridge is a plus as the organization will begin using the platform in the coming months.

Excellent attention to detail and organizational skills.

Effective communication skills and ability to collaborate across functions and levels.

Ability to work independently and manage multiple priorities in a fast-paced environment.