Regulatory Affairs Manager - Submissions Team

County Dublin Engineering & Life Sciences

Ref: 11703

Regulatory Affairs Manager - Submissions Team Are you a results and performance driven Regulatory Affairs professional with 4 to 5 years of experience in submissions looking to move the next big step in your career? Are you also a leader by nature, with strong attention to detail and positive and proactive approach to business looking to manage your own team? Look no further, here is the opportunity you have been dreaming about! This is a one of a kind chance to work and grow within a well-established pharmaceutical company operating globally. Their submission team is growing fast and they need someone like you who can join them and work within a fast-paced and international environment, manage the submissions process and achieve long term account goals in line with the company vision and values. This is a permanent full-time position based in Dublin. What will you do in this job? You will manage and oversee the coordination of regulatory submissions assigned to the RA submissions team You will ensure that the documentation compiled by your team is complete and complies with the regulatory requirements. You will be tracking the submission process by communicating efficiently with the relevant stakeholders and local service providers. You will ensure timely responses to regulatory agencies queries raised during the process. You will ensure that Marketing Authorisation Applications are current and compliant. You will ensure that Change Control requests are assessed and regulatory impact assessment is performed with respect to regulatory requirements. You will assist new business development through audit. What do you need to be successful in this job? You have 4-5 years of submission experience, ideally with some management/supervisory experience. You have strong working knowledge of regulatory requirements and procedures required, with a solid understanding of EU regulations which includes a good understanding of eCTD requirements. You have a solid knowledge of IT tools specific for in RA and pharmaceutical sector (as eCTD, databases, change control management etc.) What's in it for you? A competitive salary. A benefits package which includes pension and health care contribution, bonus, etc. Time to rest, with 23 days of paid annual leave. And... much more! The Next Step for you: Interested in this role? Please send your CV to SIMONA MORELLI at Next Generation Recruitment by clicking on the Apply button! Not ready to apply just yet? Meet with our recruiters here or get some inspiration to update your CV there. Next Generation specialise in Life Science, Engineering, Supply Chain & Operations, Data Science, Digital Marketing, and IT. Next Generation will never share your data outside of our organisation without your prior written consent; all our calls are recorded for training and quality purpose. Please read our Data Protection Policy on our website.

Process Specialist

Dublin Engineering & Life Sciences

Ref: 11702

Process Specialist If you are a spectacular Process Improvement Specialist who wants to take the next step working at an amazing company then keep reading! Are you looking to grow your career further in the Pharmaceutical Industry? My client is continually growing and they are currently looking for someone to join their Production team. Within this role you will be part of the Process Improvement Team where you will play a key role in process investigations, identifying any issues and delivering on process improvement projects. This is a permanent role based in Dublin. What will you do in this job? Responsible for investigations into any process issues Proactively stay ahead of process issues arising by continually working on process improvements Lead any changes that may arise from planned improvements Support product release timelines SME for production area on any projects that may arise What do you need to be successful in this job? Relevant degree in a Science or Engineering related discipline. 3+ years of relevant process improvement experience within the Life Science industry. Experience in a GMP Manufacturing facility 6 Sigma experience or other continuous improvement methodologies required The Next Step for you: Interested in this role? Please send your CV to Emma Wickham at Next Generation Recruitment by clicking on the Apply button! Not ready to apply just yet? Meet with our recruiters here or get some inspiration to update your CV there. Next Generation specialise in Life Science, Engineering, Supply Chain & Operations, Data Science, Digital Marketing, and IT. Next Generation will never share your data outside of our organisation without your prior written consent; all our calls are recorded for training and quality purpose. Please read our Data Protection Policy on our website.

Laboratory Operations Manager

City of Cork Engineering & Life Sciences

Ref: 11701

Environmental Laboratory Operations Manager Could this Laboratory Operations Manager role be your next dream job? Due to ongoing expansion and a recent acquisition my client, a contract testing laboratory, is growing their environmental laboratory team and they are looking for someone to step into a Laboratory Manager position. You will be responsible for mentoring a team of analysts to achieve a high quality service for their clients This is a permanent job based in Cork. What will you do in this job? Mentoring and coaching a team of analysts Ensure efficient testing turnaround for clients Play a key role in client engagement Be the go to person for prioritising of work, managing timelines and any issues that may arise Managing laboratory resources Scheduling analysts daily/weekly activities Point of contact for INAB audits and any customer audits Sign off for certs of analysis What do you need to be successful in this job? You have a minimum BSc. in a Scientific related discipline 5 years of experience with 2+ years in a people management role You have knowledge of ICP-MS, GC-MS or LC-MS The Next Step for you: Interested in this role? Please send your CV to Emma Wickham at Next Generation Recruitment by clicking on the Apply button! Not ready to apply just yet? Meet with our recruiters here or get some inspiration to update your CV there. Next Generation specialise in Life Science, Engineering, Supply Chain & Operations, Data Science, Digital Marketing, and IT. Next Generation will never share your data outside of our organisation without your prior written consent; all our calls are recorded for training and quality purpose. Please read our Data Protection Policy on our website.

Senior Accountant

Tipperary Sales & Operations

Ref: 11685

Senior Accountant - FMCG - County Tipperary Are you a qualified accountant with 3 to 4 years of experience in the FMCG industry looking for a challenging opportunity? Are you ambitious, positive, professional and a leader by nature? Have you been dreaming about working with a leading organization in the food industry and growing and developing your skills even further within a dynamic role and a fast-paced environment? If so, it is time to take action and get in touch with me! My client, a well-recognised organization in the FMCG industry is looking for a qualified Senior Accountant who would join their Finance team in County Tipperary. Responsibilities: Prepare and review monthly management accounts to the highest standards on time, ensuring accuracy and appropriate supporting details are in place. Prepare and review the weekly production pack plus variance analysis for management purposes. Review standard costing versus actual costings for all products. Communicate and post intercompany recharges and reconcile intercompany accounts. Prepare and submit all regulatory, tax and statistical returns on a timely basis. Liaise and assist Head of Finance in the preparation of annual Budgets. Stock control & stock reconciliations for multiple stock locations. Assist in the preparation of Grants & R&D TC claims. Lead & develop the AR/AP team, closely managing the team's performance and professional development. Requirements: ACA/ACCA/CPA/CIMA qualified accountant with 3-4 years of experience in the FMCG industry Demonstrated leadership ability to oversee and develop the accounting administration team Highly proficient in Excel Knowledge of Insight a distinct advantage Payroll experience is an advantage The Next Step for you: Should this position be of interest to you please forward your CV to Simona Morelli at Next Generation Recruitment via the Apply button. Next Generation are specialists in recruiting for roles in Data Science, Digital, Engineering & Life Sciences, IT, Supply Chain & Operation, Engineering and Procurement.

Environmental Chemists (Organic & Analytical) - Cork and Shannon

County Cork Engineering & Life Sciences

Ref: 11698

Environmental Chemists (Organic and Analytical) Ready to move into your next role as an Environmental Chemist and looking to grow your career in an Environmental Laboratory? Look no further, this is the job for you! I am currently working on a number of chemist roles within an expanding contract laboratory. Following a recent acquisition, the laboratory team is growing and they need someone like you to join them. These are permanent roles with positions based in both Cork and Shannon. What will you do in this job? Analytical testing of water, effluent, wastewater, etc. Analysis includes LC-MS, GC-MS, ICP-MS among other techniques Method developments and validations Troubleshooting of instruments and methods What do you need to be successful in this job? You have 2 years of experience in a similar role You have experience with LC-MS, ICP-MS or GC-MS You have a degree in a scientific related discipline The Next Step for you: Interested in this role? Please send your CV to Emma Wickham at Next Generation Recruitment by clicking on the Apply button! Not ready to apply just yet? Meet with our recruiters here or get some inspiration to update your CV there. Next Generation specialise in Life Science, Engineering, Supply Chain & Operations, Data Science, Digital Marketing, and IT. Next Generation will never share your data outside of our organisation without your prior written consent; all our calls are recorded for training and quality purpose. Please read our Data Protection Policy on our website.

Supply Chain Project Manager - Product Launch

Dublin Supply Chain & Procurement

Ref: 11562

A leading global bio-pharmaceutical has undergone significant expansion at local , regional and global level primarily through product development and organic growth . Alongside this expansion the organisation has under gone significant transformation within their global supply chain processes and as result are looking to hire a senior supply chain project manager to join their global supply chain team This role will report into Associate Director of Global Supply and will focused on driving and managing multiple global projects in relation to new product introduction and product launch. A key part of this role will be internal stakeholder management at senior level of the organisation in relation to supply chain project manager across all functions at a global level across NPI and global product launch . Another key focus of this role will be lead continuous improvement projects across all areas of the global product launch as the organisation transitions towards internal manufacturing within their global supply chain . This position will also require the individual will also to work cross functionally with their current contract manufacturers to ensure all global product launch processes are fit for purpose. Ideally degree qualified with 6-8 years supply project management experience at a global or regional level ideally within the life science sector. Strong project management experience is essential . Strong product launch experience would be an advantage. A project management qualification is a distinct advantage. The Next Step for you: Should this position be of interest to you please forward your CV to Sarah Mac Mullan from Next Generation Recruitment or alternatively call on the main line on 00 353 1662 9120 Next Generation are specialists in Engineering, Data Science, Digital, Finance, IT Contract, IT Permanent, Life Sciences, Supply Chain, Procurement and Operations Applications are in strict confidence. Next Generation will never share your data outside of our organisation without your prior written consent; all our calls are recorded for training and quality purpose. Please read our Data Protection Policy on our website.

Senior IT Recruiter

Dublin Careers at Next Generation

Ref: 11691

Ready to move into your next role as a Senior IT Recruiter? Next Generation is a small but mighty 13 years old recruitment agency; we focus on two main areas: IT and Life Science. Right now, we need a Senior IT Recruiter to join our team. You will join another amazing recruiter on this desk. I'm not going to give you their name; if you're a half-way decent recruiter, you'll find it in under 20 seconds. Bonus point if you add their name to your application. This is a permanent part-time job and our office is based in Dublin right by St Stephen's green. Maybe you enjoyed the lock-down and don't want to be working 5 days a week anymore or maybe you're returning to work and 3-4 days a week seems like the perfect work-life balance. Whatever the reason, we need an IT Recruiter starting with us in September! What will you do in this job? You will sell! Yes, in recruitment we're always selling something, right? You will generate your own book of business through traditional business development and inbound sales strategies. You will build relationships with your client's hiring managers in order to help them hire the best team possible. You will leave no stone unturned to find the best candidates for the role and you will guide them throughout the recruitment process all the way to giving them a good luck phone call before their 1 st day. What do you need to be successful in this job? You have 3-5 years of experience as a recruiter on the agency side. You are an IT recruiter. If you can barely turn your PC on, we'll cope, but we really need you to have experience recruiting for technical roles on the Irish market. This is a hands-on 360 recruiter role so BD, sourcing, and recruiting are core parts of the job. What's in it for you? A competitive salary with quarterly incentives and a strong commission structure. Flexibility to work remotely or from the office, we have laptops and VoIP phone, so no pandemic will stop us! Time to rest, with the 22 days of paid annual leave + your birthday off! A career development path. A marketing team to support your inbound sales effort. We care about our colleague's wellness, so we have an Employee Assistance Programme (EAP) a Wellness Programme and an Education scheme. We make commute easier with the Tax Saver schemes and the Bike to work scheme (and secure bike parking). And... much more! (but a lot of it was office-based, so we're rethinking everything) The Next Step for you: Interested in this role? Please send your CV to Chloe Morisson at Next Generation Recruitment by clicking on the Apply button! Not ready to apply just yet? Meet with our recruiters here or get some inspiration to update your CV there. Next Generation specialise in Life Science, Engineering, Supply Chain & Operations, Data Science, Digital Marketing, and IT. Next Generation will never share your data outside of our organisation without your prior written consent; all our calls are recorded for training and quality purpose. Please read our Data Protection Policy on our website.

Head of Product Development

Dublin Digital

Ref: 11697

Could this Head of Product Development role be your next dream job? Are you looking to grow your career in the media production industry? Look no further, this is the job for you! You will be a vital part of the digital innovation team, helping my client grow their digital revenue by delivering innovative commercial products and assisting them with your technical expertise. This is a permanent and full-time position based in Dublin. What will you do in this job? You will be responsible for developing industry-leading digital products. You will effectively communicate and collaborate with the ad ops, web development T&I team, and sales teams to deliver unique digital campaign opportunities You will lead commercial brainstorms from a technical perspective and thoroughly investigate, and test third-party digital market offering. You will assist the ad ops team in optimising overall performance. What do you need to be successful in this job? You have a minimum of 3 years of experience in product development, if it is with a publisher or a media agency, that would be amazing. You will have experience of delivering highly impactful digital products. You will have advanced knowledge of advertising operations, analytics and product development. You will have a proven web development experience. You will have exceptional technical understanding and prowess. What's in it for you? A competitive salary with exceptional bonus. Pension contribution. Do you enjoy travelling? Then there would be occasional travel-associated, once the pandemic is over. The Next Step for you: Interested in this role? Please send your CV to Varun Reddy at Next Generation Recruitment by clicking on the Apply button! Not ready to apply just yet? Meet with our recruiters here or get some inspiration to update your CV there. Next Generation specialise in Life Science, Engineering, Supply Chain & Operations, Data Science, Digital Marketing, and IT. Next Generation will never share your data outside of our organisation without your prior written consent; all our calls are recorded for training and quality purpose. Please read our Data Protection Policy on our website.