Regulatory Submissions & Asset QA Associate

RXinsider LTD.; Dublin; On-site; EUR 42,000 - 62,000; Full time

Job summary

Azurity Pharmaceuticals is seeking an Associate, Annotator / PMRC Submission Support to prepare, annotate and submit marketing assets in the MLR system. You will ensure claims, references, fair balance and supporting documents are complete and review-ready.

Responsibilities include QA for regulatory compliance, cross-channel asset preparation, and ensuring alignment with internal conventions and Vodori/MLR requirements. Prior experience with FDA rules and multi-territory regs is a plus.

Qualifications

• Experience with FDA promotional regulations for pharma marketing.
• Familiarity with regulatory affairs across multiple territories.
• Ability to annotate claims, references and supporting materials precisely.

Responsibilities

• QA marketing assets for compliance with territory promotional regulations.
• Prepare promotional assets for MLR submission across channels.
• Annotate claims, references, product information, fair balance and safety language.
• Ensure submissions are complete and aligned with naming conventions and Vodori/MLR system requirements.
• Create master submissions and addenda for campaign assets with tracking.
• Verify all materials are included before submission (ISI, copy, references, ISI, etc.).
• Collaborate with designers, copywriters, brand teams and reviewers to resolve issues.
• Track submission status, approvals, resubmissions and final assets.
• Maintain version control and ensure assets are stored and accessible for downstream use.
• Support post-approval processes, including OPDP/FDA submission preparation when required.

Skills

MLR submission

annotation

reference management

version control

asset tracking

claims support

document QC

campaign addenda

approval workflows

Education

Degree in life sciences/regulatory affairs

Tools

Vodori

Veeva

Job description

Azurity Pharmaceuticals is seeking an Associate, Annotator / PMRC Submission Support to prepare, annotate and submit marketing assets in the MLR system. You will ensure claims, references, fair balance and supporting documents are complete and review-ready.

Responsibilities include QA for regulatory compliance, cross-channel asset preparation, and ensuring alignment with internal conventions and Vodori/MLR requirements. Prior experience with FDA rules and multi-territory regs is a plus.