Pharma Submissions & Annotations Associate

Azurity Pharmaceuticals - Ireland; Dublin; On-site; EUR 45,000 - 65,000; Full time

Job summary

Azurity Pharmaceuticals is seeking an Associate, Annotator / PMRC Submission Support to prepare, annotate, and submit marketing assets into the MLR workflow. You will verify every claim and reference, ensure compliance with FDA and territorial regulations, and coordinate with design and brand teams to produce audit-ready submissions.

The role focuses on accuracy, version control, and timely submissions across campaigns, with close collaboration among reviewers, designers, and copywriters to

Qualifications

• Experience with FDA promotional regulations for pharma marketing.
• Experience in regulatory review across territories including Europe.
• Ability to annotate and submit marketing assets into MLR systems.

Responsibilities

• QA output from internal teams to ensure compliance with territory regulations.
• Prepare promotional assets for MLR submission across multiple channels.
• Annotate claims, references, product information, fair balance, safety language and data points.
• Ensure submissions are complete, structured and aligned with naming conventions and system requirements.
• Create master submissions and addenda for campaign assets and tracking.

Skills

MLR submission & annotation

Reference management

Vodori/Veeva

Version control

Asset tracking

Claims support

Document QC

Campaign addenda

Approval workflows

FDA regulatory knowledge

Education

Degree in life sciences, pharmacy, medicine, regulatory affairs, healthcare, communications or related fields

Tools

Vodori/Veeva

Job description

Azurity Pharmaceuticals is seeking an Associate, Annotator / PMRC Submission Support to prepare, annotate, and submit marketing assets into the MLR workflow. You will verify every claim and reference, ensure compliance with FDA and territorial regulations, and coordinate with design and brand teams to produce audit-ready submissions.

The role focuses on accuracy, version control, and timely submissions across campaigns, with close collaboration among reviewers, designers, and copywriters to