Regulatory Affairs Manager
Hartley People
Tipperary, Cork, Kilkenny
Hartley People are currently recruiting for a Regulatory Affairs Manager on behalf of our client based in Tipperary. Remuneration: Negotiable depending on experience. Contact: Hartley People Recruitment (Pairic Doyle. 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. If you meet the criteria for this position, we will provide a full consultation in confidence and we guarantee that your CV will not be sent to any of our clients without your consent. For immediate consideration please call Sara Brennan on 051-878813 or email your CV in a word document to sarabrennan@hartleypeople.com.
3088 days ago