Regulatory Affairs Associate

3 weeks ago

Dublin, Ireland Xeolas Full time

Dublin, Ireland - Permanent Full Time Role

Xeolas Pharmaceuticals is a proudly Irish-owned specialty pharmaceutical company based in Dublin, with a team of over 70 professionals. We develop and manufacture innovative, patient-friendly pharmaceutical products for international markets. As we expand our in-house capabilities, we are seeking a skilled Regulatory Affairs Associate to support our regulatory publishing and submission activities.

Role Overview

The Regulatory Affairs Associate will play a key role in supporting the preparation, publishing, and submission of regulatory documentation for both new applications and lifecycle maintenance of existing products. This position offers an excellent opportunity to contribute to a growing regulatory function within a dynamic and innovation-driven organization.

Reporting To

Regulatory Affairs Manager

Key responsibilities

- Support the compilation of regulatory dossiers for EU and Rest of World (ROW) submissions.
- Assist in the preparation and submission of variations, responses to regulatory queries, and other regulatory documentation.
- Support with administrative tasks such as CPP, GMP and MIA request.
- Perform operational tasks related to document authoring, including formatting, editing, reviewing, publishing, and archiving (both paper and electronic).
- Conduct quality reviews of submission documents to ensure accuracy, completeness, and compliance with regulatory standards.
- Manage project workflows throughout the submission lifecycle, ensuring timelines are met and proactively addressing issues or resource needs.
- Review of R&D documents for under development projects.
- Stay informed of evolving regulatory requirements and submission standards.
- Undertake additional tasks as assigned by the Regulatory Affairs Manager.

Qualifications & Experience

- Bachelor's degree in Health Sciences or a related field, or equivalent relevant experience.
- 1-3 years of experience in the pharmaceutical regulatory industry.
- Solid understanding of regulatory affairs principles, applicable regulations, and guidance documents.
- Strong attention to detail, organizational skills, and ability to manage multiple priorities.

Apply for this Job

Please send a cover letter and your cv to

#J-18808-Ljbffr

  • Regulatory Affairs Specialist

    4 weeks ago

    Dublin, Ireland Xeolas Full time

    Dublin, Ireland - Permanent Full Time RoleXeolas is an Irish-owned speciality Pharmaceutical company located in Dublin, Ireland with 80+ employees.We develop and manufacture innovative patient friendly pharmaceutical products for international markets.We are now seeking an experienced Regulatory Affairs Specialist as we expand.Overall Role ObjectiveThe...

  • Head of Regulatory Affairs, Europe

    4 weeks ago

    Dublin, Ireland Scholar Rock Full time

    Overview Scholar Rock is a biopharmaceutical company that discovers, develops, and delivers life-changing therapies for people with serious diseases that have high unmet need. As a global leader in the biology of the transforming growth factor beta (TGFβ) superfamily of cell proteins, the clinical-stage company is focused on advancing innovative treatments...

  • Head Of Regulatory Affairs, Europe

    4 weeks ago

    Dublin, Ireland Scholar Rock Full time

    OverviewScholar Rock is a biopharmaceutical company that discovers, develops, and delivers life-changing therapies for people with serious diseases that have high unmet need.As a global leader in the biology of the transforming growth factor beta (TGFß) superfamily of cell proteins, the clinical-stage company is focused on advancing innovative treatments...

  • (10/19/2025 A) Regulatory Affairs Specialist

    3 weeks ago

    Dublin, Ireland Xeolas Full time

    Dublin, Ireland - Permanent Full Time Role Xeolas is an Irish-owned speciality Pharmaceutical company located in Dublin, Ireland with 80+ employees. We develop and manufacture innovative patient friendly pharmaceutical products for international markets. We are now seeking an experienced Regulatory Affairs Specialist as we expand. Overall Role...

  • Sr Mgr Regulatory Affairs

    3 weeks ago

    Dublin, Ireland Regeneron Ireland Full time

    At Regeneron, we're advancing science and medicine to improve lives. We're seeking a talented Regulatory Affairs Manager to join our team and play a pivotal role in supporting EU regulatory activities for oncology drug development. This is your chance to contribute to groundbreaking clinical development programs while collaborating with global experts and...

  • Senior Director, Regulatory Affairs

    4 days ago

    Dublin, Ireland Perrigouk Full time

    Select how often (in days) to receive an alert: Senior Director, Regulatory Affairs - CMC, Regulatory Operations & Lifecycle Management Location: London, GB, SW11 7BW Chatillon Cedex, FR, 92320 Ghent, BE, 9050 Dublin, IE, D02 TY74 At Perrigo, we are driven by our mission to Makes Lives Better Through Trusted Health and Wellness Solutions, Accessible to All....

  • Regulatory Affairs Analyst

    4 weeks ago

    Dublin, Ireland Gofundme Full time

    OverviewGoFundMe is hiring a Regulatory Affairs Analyst to interpret regulatory changes and ensure our products, policies, and communications comply with all relevant laws and standards.This includes preparing reports, documentation, and responses to regulatory agencies while collaborating across teams to integrate compliance into product planning.Join us!If...

  • Regulatory Affairs Analyst

    3 weeks ago

    Dublin, Ireland Gofundme Full time

    OverviewGoFundMe is hiring a Regulatory Affairs Analyst to interpret regulatory changes and ensure our products, policies, and communications comply with all relevant laws and standards.This includes preparing reports, documentation, and responses to regulatory agencies while collaborating across teams to integrate compliance into product planning.Join us!If...

  • Regulatory Affairs Analyst

    1 week ago

    Dublin, Ireland GoFundMe Full time

    Overview GoFundMe is hiring a Regulatory Affairs Analyst to interpret regulatory changes and ensure our products, policies, and communications comply with all relevant laws and standards. This includes preparing reports, documentation, and responses to regulatory agencies while collaborating across teams to integrate compliance into product planning. Join...

  • Senior Director, Global Regulatory Affairs Liaison – Pediatric Center Of Excellence

    4 weeks ago

    Dublin, Ireland Gilead Sciences, Inc. Full time

    At Gilead, we're creating a healthier world for all people.For more than 35 years, we've tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer – working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe.We continue to fight against the world's biggest health challenges, and our...