Associate, Annotator / PMRC Submission Support
Azurity Pharmaceuticals - Ireland
Salary undisclosed
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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.
#LI-Hybrid
About this role
Azurity Pharmaceuticals is seeking an Associate to manage the quality assurance and regulatory submission of promotional materials across multiple channels and markets. You would prepare, annotate, and submit marketing assets—ranging from social media and email to video and print—into the MLR review system, ensuring every claim, reference, and compliance element meets territory regulations before it reaches reviewers. The role demands precision in tracking claims against source materials, managing fair balance and safety language, and maintaining version control across campaigns.
This position suits someone with working knowledge of FDA promotional regulations and ideally experience with European regulatory requirements as well. You'll need hands-on familiarity with Vodori or similar MLR systems, reference management, and document QC workflows. The day-to-day involves coordinating with creative teams, copywriters, and brand managers to resolve missing references or formatting issues, then tracking submissions through approval cycles and into post-approval processes. A background in life sciences, pharmacy, regulatory affairs, or healthcare communications is preferred.
Based in Dublin, the role is hybrid with Tuesday–Thursday office attendance required. It's a full-time position at a specialty pharma company focused on underserved patient populations across cardiovascular, neurology, endocrinology, and other therapeutic areas.
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Pay for this role
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