▷ (Apply Now) Regulatory Operations Associate

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 70+ employees. We develop and manufacture innovative patient friendly pharmaceutical products for international markets. We are now seeking an experienced Regulatory Operations Associate as we bring in-house publishing.

Overall Role Objective

The Regulatory Operations Associate will report directly to the Regulatory Affairs Manager and will have a range of responsibilities focused on ensuring the accurate and timely submission of electronic regulatory documents for existing licensed products for life cycle maintenance and new submissions.

Reporting To

Manager Regulatory Affairs

Key responsibilities of Regulatory Operations Associate

- Provide support for submissions and other documents by performing necessary tasks including photocopying, scanning and printing, assembly, dispatch and coordinating resources for submissions
- Responsible for all aspects of publishing submissions and/or submission components for internal review and signoff, and for submission to regulatory authorities. This includes all operational tasks associated with or in support of authoring (formatting, editing, reviewing, publishing, production (paper and electronic), and archiving (paper and electronic), as applicable
- Preparation of published output for either paper or electronic formats ensuring high-quality documents in adherence with regulatory guidelines and internal processes within established time lines
- Maintain submission components associated with a regulatory submission, paper and/or electronic, as required. This may include, but is not exclusive to, setting up templates, updating procedures, and project tracking
- Assemble electronic and paper Regulatory Submissions and packages for European, US Food and Drug Administration, the European Medicines Agency and other international regulatory authorities using Lorenz software
- Perform quality review on submission documents to ensure accuracy and completeness.
- Responsible for managing project workflow throughout the submission process, including prioritizing project objectives, and overseeing progress of projects with other team members, ensuring timeframes and deadlines are met and identifying and relaying issues and resource needs when required
- Provide technical support and guidance on eCTD publishing tools and software
- Stay updated on changes in regulatory requirements and submission standards
- Train and mentor staff on eCTD publishing processes and best practices

Key Skills / Experience Requirements

- B.Sc. or related degree in Health Sciences or equivalent relevant experience and training.
- 3-5 years pharmaceutical regulatory industry / regulatory operations experience
- Experience working with current eCTD standards is required
- Understanding of applicable regulations and guidelines documents

Apply for this Job

Please send a cover letter and your cv to

#J-18808-Ljbffr

  • 3 Days Left! Regulatory Operations Associate

    4 weeks ago

    Dublin Pike, Ireland Xeolas Full time

    Dublin, Ireland - Permanent Full Time Role Xeolas is an Irish-owned speciality Pharmaceutical company located in Dublin, Ireland with 70+ employees. We develop and manufacture innovative patient friendly pharmaceutical products for international markets. We are now seeking an experienced Regulatory Operations Associate as we bring in-house...

  • Sr Mgr Regulatory Affairs

    1 week 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...

  • Associate Director Regulatory Affairs

    4 weeks ago

    Dublin, Ireland Quanta Consultancy Services Ltd Full time

    OverviewAssociate Director Regulatory Affairs - Ireland, Dublin - 12 Month ContractAre you looking for the chance to join a life changing pharmaceutical organisation in their mission to continuously drive innovation?We are recruiting for a Associate Director Regulatory Affairs to support the Dublin function.ResponsibilitiesDeveloping and implementing global...

  • Regulatory Affairs Associate

    2 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...

  • ▷ Urgent Search: Associate Director Regulatory Affairs

    3 weeks ago

    Dublin, Ireland Quanta Consultancy Services Ltd Full time

    Overview Associate Director Regulatory Affairs - Ireland, Dublin - 12 Month Contract Are you looking for the chance to join a life changing pharmaceutical organisation in their mission to continuously drive innovation? We are recruiting for a Associate Director Regulatory Affairs to support the Dublin function. Responsibilities - Developing and...

  • Regulatory Associate Director

    4 weeks ago

    Dublin Pike, Ireland Grant Thornton Ireland Full time

    Regulatory Associate Director page is loaded Regulatory Associate Director Apply locations Dublin time type Full time posted on Posted 4 Days Ago job requisition id JR7787 Regulatory Associate Director We are Grant Thornton. We go beyond business as usual, so you can too. Grant Thornton Ireland (GT) has nearly 3,000 people in 9 offices across Ireland, The...

  • Regulatory Associate Director

    3 weeks ago

    Dublin, Ireland Grant Thornton Ireland Full time

    Regulatory Associate Director page is loadedRegulatory Associate DirectorApply locations Dublin time type Full time posted on Posted 4 Days Ago job requisition id JR****Regulatory Associate DirectorWe are Grant Thornton.We go beyond business as usual, so you can too.Grant Thornton Ireland (GT) has nearly 3,000 people in 9 offices across Ireland, The Isle of...

  • Regulatory Associate Director

    3 weeks ago

    Dublin, Ireland Grant Thornton Ireland Full time

    Regulatory Associate Director page is loadedRegulatory Associate DirectorApply locations Dublin time type Full time posted on Posted 4 Days Ago job requisition id JR7787Regulatory Associate DirectorWe are Grant Thornton.We go beyond business as usual, so you can too.Grant Thornton Ireland (GT) has nearly 3,000 people in 9 offices across Ireland, The Isle of...

  • Regulatory Affairs Associate

    3 weeks ago

    Dublin, Ireland Xeolas Full time

    Dublin, Ireland - Permanent Full Time RoleXeolas 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 skilledRegulatory...

  • Public Regulatory Associate, Dublin

    3 weeks ago

    Dublin, Ireland BCL Legal Full time

    Overview Public, Regulatory & Investigations Associate - Dublin A leading law firm is seeking to recruit an Associate (1-5 PQE) to join its well-established Public, Regulatory & Investigations team. This role offers the opportunity to work within one of the most highly regarded public law practices in the country. The team is consistently recognised for...