Regulatory Operations Associate
14 hours ago
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
-
Head of Regulatory Affairs
7 hours ago
Dublin, Ireland Tether Operations Limited Full timeSince its inception in 2014 by pioneering Bitcoin enthusiasts, Tether has not only launched the first 'stablecoin', USD₮, but also expanded its horizons into Tether Data, Tether Power, Tether Edu, and more. Our platforms and tokens lead in liquidity, stability, and innovation, setting the foundation for the future. Tether is committed to the...
-
High Salary: Global Regulatory
20 hours ago
Dublin, Ireland Quanta Consultancy Services Ltd Full timeGlobal Regulatory & Operations Lead - Operations Lead - Ireland/Dublin Our client is a global supplier of sterile injectable pharmaceutical products. They currently market and distribute a portfolio of sterile injectable drugs. Our state-of-the-art research and development organization has a robust pipeline of products in development that we will bring to...
-
Director, Regulatory Operations
20 hours ago
Dublin, Ireland ICON Clinical Research Limited Full timeDirector, Regulatory Operations ICON plc is a world-leading healthcare intelligence and clinical research organization. We're proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development. We are currently seeking a Director, Regulatory Operations to join...
-
Regulatory Operations Manager Legal
20 hours ago
Dublin, Ireland Rippling Full timeRippling gives businesses one place to run HR, IT, and Finance. It brings together all of the workforce systems that are normally scattered across a company, like payroll, expenses, benefits, and computers. For the first time ever, you can manage and automate every part of the employee lifecycle in a single system. Take onboarding, for example. With...
-
Head of Regulatory Reporting
20 hours ago
Dublin, Ireland FK International Full timeOverview Large conglomerate bank with theDublin office acting as a gateway to access the European market. Chiefly dealing with Corporate Loans, Equities, Derivatives, etc. Managing a small team, your role here will report jointly to the CFO of Europe as well as the overall European Head of Regulatory Reporting. Youll head up a team of 4 on the reporting...
-
Finance & Operations Associate
3 minutes ago
Dublin, Ireland The Panel Group Full timeA financial services firm is seeking to hire a Finance and Operations Associate to join their team in Dublin city centre. This role involves managing the day-to-day operations of investment funds across various asset classes, including private equity, hedge funds, and real estate. The position also entails providing oversight of externally administered asset...
-
Compliance Officer
7 hours ago
Dublin, Ireland J.P MORGAN S.E Dublin Branch Full timeJob Description We are seeking to hire a regulatory Compliance professional at Associate level to join the J.P. Morgan Ireland Compliance team based in Dublin. This is a fantastic opportunity for a self-motivated, control minded individual to develop their career within a leading global financial services firm and gain broad exposure to dynamic multifaceted...
-
Senior Regulatory Affairs Specialist
14 hours ago
Dublin, Ireland Life Science Recruitment Full timeSenior Regulatory Affairs Specialist Our client, a Medical Device Multinational, currently seeks a Senior Regulatory Specialist to join their team. The Senior Regulatory Affairs Specialist will develop strategies and submissions for complex projects and issues related to regulatory documents, submissions, investigations, product development planning, and...
-
Associate Director Quality Operations
20 hours ago
Dublin, Ireland Grifols, S.A Full timeWould you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and...
-
Healthcare Senior Associate
20 hours ago
Dublin, Ireland BCL Legal Full timeDefendant Healthcare Senior Associate - Dublin A highly ranked Healthcare firm in Dublin are seeking to recruit a defendant clinical negligence senior associate. As part of the firm's growth the team are looking for an ambitious senior associate to join their Dublin office. The Role · You will be joining a well-regarded defendant clinical negligence...
-
Senior Associate QC
20 hours ago
Dublin, Ireland Life Science Recruitment Ltd Full timeSenior Associate Quality Control 12 Months AS33795 Were currently recruiting for an exciting opportunity with an award-winning Pharmaceutical organization based in Dublin. This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do. Senior Associate Quality Control will be someone with a...
-
Commercial Attribute Sciences
14 hours ago
Dublin, Ireland Amgen SA Full timeOverview: Commercial Attribute Sciences – Associate Scientist This job specification outlines the general responsibilities associated with the role of Associate Scientist within the Commercial Attribute Science (CAS) Dept. of Process Development at Amgen Dun Laoghaire (ADL). This role will be responsible for supporting activities related to the three...
-
Dublin, Ireland Davy Full timeAbout us From day one, you’ll notice there is something special about working at Davy. Our success is built on nearly 100 years of forging strong relationships with our clients and developing the careers of Ireland’s future business leaders. Established in 1926, the Davy Group sits at the heart of wealth and capital in Ireland, providing a broad range...
-
Operational Lead
7 days ago
Dublin, Ireland TEAM HORIZON Full timeTeam Horizon is seeking a Operational Lead to serve as primary production process owner responsible for New Production Introduction, lice cycle management projects and or CAPEX projects and established process improvements projects. This role requires in depth technical and operational knowledge of aseptic drug product manufacturing processes ; parts/...
-
Operational Lead
7 days ago
Dublin, Ireland Team Horizon Full timeTeam Horizon is seeking a Operational Lead to serve as primary production process owner responsible for New Production Introduction, lice cycle management projects and or CAPEX projects and established process improvements projects. This role requires in depth technical and operational knowledge of aseptic drug product manufacturing processes ; parts/...
-
▷ [Urgent Search] Risk Associate
20 hours ago
Dublin City Centre, Ireland FRS Recruitment Full timei'm currently working with a client seeking to add a Risk Associate to their financial services team. My client is based in the city centre and this role offers hybrid working. Responsibilities: - Manage and enhance risk frameworks and registers. - Perform 2nd line control testing and identify improvements. - Provide risk insights to senior leadership...
-
Dublin, Ireland Deloitte Ireland LLP Full timeDeloitte is the biggest professional services Firm in the world, and making an impact is more than just what we do: it's why we're here. We're driven to create positive progress for our clients, community, people, and the planet. This sense of purpose inspires us to work to the highest standards, to tackle the challenges that matter. D eloitte has been...
-
Senior Operations Manager
20 hours ago
Dublin, Ireland FRS Recruitment Full timeCurrently recruiting for a Senior Operations Manager for my client who are a manufacturing company based in Dublin. The successful candidate is required to have a working knowledge of all duties in the specific areas of personnel management, production and delivery operations, quality control, sales and customer service, raw material and inventory...
-
Pension Support, Senior Associate
20 hours ago
Dublin, Ireland Davy Full timeAbout us From day one, you’ll notice there is something special about working at Davy. Our success is built on nearly 100 years of forging strong relationships with our clients and developing the careers of Ireland’s future business leaders. Established in 1926, the Davy Group sits at the heart of wealth and capital in Ireland, providing a broad range...
-
Senior Associate Quality Control
14 hours ago
Dublin, Ireland Life Science Recruitment Full timeSenior Associate Quality Control AS3646 12 Months Dublin We’re currently recruiting for an exciting opportunity with an award-winning Pharmaceutical organization based in Dublin. This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do. Duties: 1. Plan and perform analyses with great...