MLR Submissions Associate: Regulatory Annotations

Azurity Pharmaceuticals - Ireland; Leinster; Hybrid; EUR 45,000 - 60,000; Full time

Job summary

Azurity Pharmaceuticals in Dublin seeks an Associate, Annotator / PMRC Submission Support to prepare, annotate and submit marketing assets into the MLR review system, ensuring all claims, references, fair balance and supporting documents are complete and reviewer-friendly.

You will liaise with designers, copywriters and brand teams, maintain version control, track submissions, and assist post-approval processes including OPDP/FDA submission preparation as required.

Qualifications

• MLR submission workflow and regulatory awareness; knowledge of FDA regulations and European territories is a plus.
• Degree or higher in life sciences, pharmacy, medicine, regulatory affairs, healthcare or related field.

Responsibilities

• Prepare, annotate and submit marketing assets into the MLR review system.
• Annotate claims, references, product information, fair balance, safety language and data points.
• Ensure submissions are complete, structured, and aligned with internal conventions and system requirements.
• Liaise with designers, copywriters, brand teams and reviewers to resolve missing references or formatting issues.
• Track status of submissions, approvals and resubmissions; maintain version control and asset labelling.

Skills

MLR submission

annotation

reference management

Vodori/Veeva

version control

asset tracking

claims support

document QC

campaign addenda

approval workflows

Education

Degree in life sciences/pharmacy/medicine/regulatory affairs/healthcare/basic sciences

Tools

Vodori/Veeva

Job description

Azurity Pharmaceuticals in Dublin seeks an Associate, Annotator / PMRC Submission Support to prepare, annotate and submit marketing assets into the MLR review system, ensuring all claims, references, fair balance and supporting documents are complete and reviewer-friendly.

You will liaise with designers, copywriters and brand teams, maintain version control, track submissions, and assist post-approval processes including OPDP/FDA submission preparation as required.