Associate, Annotator / PMRC Submission Support

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 a privately held, specialty pharmaceutical company that focuses on innovative products that meet the needs of underserved patients. As an industry leader in providing unique, accessible, and high-quality medications, Azurity leverages its integrated capabilities and vast partner network to continually expand its broad commercial product portfolio and robust late-stage pipeline. The company’s patient-centric products span the cardiovascular, neurology, endocrinology, gastro-intestinal, institutional, and orphan markets, and have benefited millions of patients. For more information, visit www.azurity.com.

Azurity Pharmaceuticals is proud to be an inclusive workplace and an Equal Opportunity Employer. Azurity's success is attributable to our incredibly talented, dedicated team that focuses on benefiting the lives of patients by bringing the best science and commitment to quality into everything that we do. We seek highly motivated individuals with the dedication, integrity, and creative spirit needed to thrive in our organization.

Azurity roles are office based and are generally require individuals to be in office Tuesday through Thursday with Monday and Friday as optional days.

About The Role

The Associate, Annotator / PMRC Submission Support will prepare, annotate and submit marketing and promotional assets into the MLR review system, ensuring every claim, reference, fair balance element and required supporting document is complete, accurate and easy for reviewers to assess.

Key Responsibilities

• QA output from the internal creative team to assess if it complies with territory promotional regulations.
• Prepare promotional assets for MLR submission across social, web, email, video, banner ads, print, sales materials, and digital campaigns.
• Annotate claims, references, product information, fair balance, safety language, data points and required source materials.
• Ensure submissions are complete, clearly structured and aligned with internal naming conventions, job numbers and Vodori/MLR system requirements.
• Create master submissions and addenda for campaign assets where appropriate, including individual post, ad or asset-level tracking.
• Check that all required materials are included before submission, including final copy, layouts, references, prescribing information, ISI/fair balance, and supporting documentation.
• Liaise with designers, copywriters, brand teams and reviewers to resolve missing references, unclear claims or formatting issues before submission.
• Track status of submissions, comments, approvals, resubmissions, and final approved assets.
• Maintain version control and ensure approved assets are stored, labelled, and accessible for downstream use.
• Support post-approval processes, including OPDP/FDA submission preparation where required.

Required Skills And Experience

MLR submission, annotation, reference management, Vodori/Veeva, version control, asset tracking, claims support, document QC, campaign addenda, approval workflows. A priority is working knowledge of FDA promotional regulations for pharma marketing but experience of regulations in additional territories, including European territories would be a distinct advantage

Preferred Qualifications

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