Regulatory Affairs X4 Waterford And Tipperary

Hartley People

Tipperary, Waterford

Hartley People are currently recruiting for a Regulatory Affairs Advisor on behalf of our client based in Tipperary. The Role: Ownership/regulatory responsibility for a portfolio of products for nominated client and be responsible for close liaison with the Management/ other key personnel of the relevant business unit in the definition of product strategies in line with timeframes for approval. Maintenance of marketing authorisations for nominated client via a range of regulatory activities including submission of variationapplications and MA renewals. Communication with the appropriate competent authority to answer questions and obtain timely approval for changes. Implementation and communication of MA changes. Ensuring all compliance activities are correctly managed. Generation and maintenance of prescribing information, patient information leaflets and packaging components, including artwork management in line with regulatory requirements. Maintain sound knowledge of European regulatory requirements, regulations and guidelines to provide advice and expertise internally for matters related to client products. Provision of guidance/technical support in the preparation of EU CTD dossiers applications. Works collaboratively with other department colleagues to share best practice and information and to ensure a consistent approach with both Competent Authority & within company. Support other team members with the maintenance of the Quality Management System and ISO 9001, including generation and review of SOPs, reports and other quality documentation. The Person: • B.Sc. or pharmacy primary degree. • Greater than 3 years experience of human medicinal product Regulatory Affairsin the Pharmaceutical Industry. • Experience with electronic submissions. • Strong commercial awareness and an innate ability to assess the commercial implications of decisions and advice. • Experience in the preparation and submission of new applications, variations and renewals for multiple EU markets. • Experience in the management of DCP’s, Centralised or other European procedures. • Excellent written and oral communication skills. • Ability to project manage across a diverse and complex portfolio of products and priorities. • Ability to get on with people, to influence people both internally and externally and to achieve objectives. • Above average attention to detail and solid interpersonal, communication and organisational skills required. • Excellent attention to detail with Client Care an integral part of your work ethic. • Confidentiality and discretion. • Motivated self-starter. • Ability and desire to progress and represent the company in an exemplary manner. Regulatory Affairs Manager - Waterford. The Role Provide support for the change management process including governance and QPI metric reporting. Provide direct support for change management including regulatory assessments, change governance, monthly QPI metric reporting. Facilitate global regulatory assessments using a structured process and through engagement with international regulatory professionals and international change committees. Primary contact for regional change and also support change management. Serve as a local focal point for change requests of the various regions, along with requests for information supporting global product registrations. Provide direct support for international requests regarding registration maintenance, renewal, addition of new products or SKU’s. Help strengthen global change management network and process through proactive engagement with international peers and key stakeholders. Provide training as required to both international and domestic groups in support of the whole process. The Person Bachelors Degree in Engineering or Scientific disciplines (Chemistry, Biology, Microbiology or a related technical field. A minimum of 5 years experience in medical devices/pharma, ideally in Regulatory Affairs, R&D Quality or Operational Quality. Previous Regulatory Affairs experience is essential preferably in the medical device area. Self starter and a motivated individual. Hartley People are currently recruiting for a Regulatory Affairs Manager on behalf of our client based in Tipperary. The Role: Oversee all regulatory activities and projects within defined time schedules and in accordance with internal procedures, agreed deadlines and legislative requirements. Manage and lead assigned regulatory projects including management of budget, time-lines and submission planning. Proactively communicate regulatory strategy, key issues and any other critical topics to Managing Director. Take the lead in health authorities interaction and relationship building. Supporting pharmacovigilance activities, EVMPD, Medical Information, clinical and non-clinical work (includes writing / review of clinical overview and clinical summary documents. Management of training and mentoring of junior regulatory employees to ensure they are competent and confident in providing service excellence within the sector. Identify opportunities for business development based on a comprehensive knowledge of the sector. Continuously assess regulatory framework to ensure that the company is providing the most up to date and relevant service to clients. The Person: B.Sc. Minimum or pharmacy primary degree. A minimum of 7-10 years experience of cross-functional Regulatory Affairs in the Pharmaceutical Industry. In addition to pharmaceutical sector experience, pharmacovigilance and or medical devices would be a distinct advantage. Excellent project management skills with the ability to oversee multiple projects simultaneously. A proactive approach with the ability and experience to manage a diverse team of professionals. A proven track record in communicating with top level management and competent authorities. Solid understanding and experience of electronic Common Technical Document eCTD submissions. Strategic thinking as well as hands-on experience with different registration procedures. Demonstrate professionalism and leadership at all times. Hartley People Recruitment work to the highest ethical standards within our industry and we value the trust that you place in us when you send your CV. We can provide a full consultation in confidence and we guarantee that your CV will not be sent to any of our clients without your prior consent. For immediate consideration please call Sara on 051-878813 or email your CV in response to this job posting sarabrennan@hartleypeople.com. Hartley People also recruit for similar roles such as Regulatory Specialist, Compliance Auditor, Compliance Officer, Regulatory Officer, Regulatory Manager, Senior Regulatory Manager, Regulatory Assistant.

2960 days ago