Gold Buckinghamshire, UK
Job Title: Regulatory Affairs Consultant Location: Buckinghamshire Rate: £52 - £68 p/h Term: Initial 12 Months Hours: 37 Key Skills: EMEA, Medical, Pharmaceutical, Drug Development, MRP, CP, Regulatory Affairs, Requirements, EU, SmPC, LOC, CRO, GRL, Commercialization An experienced Regulatory Affairs Consultant is required to join my client to advise project teams on applicable regulatory issues, project specific issues and issues related to regional regulatory climates. You must have a breadth of regulatory experience in Drug Development & commercialization - therapeutic areas, products, development. Working from site, this is a truly fantastic opportunity for the right person. If this sounds like an opportunity for you, please read on! The Role: So, what will you be doing as a Regulatory Affairs Consultant? Drive the understanding of central & national regulatory requirements Develop and ensure effective implantation of regional regulatory strategy and tactics in support of the global development plan Provide input for developing & updating the Target EU SmPC Maintain & establish strong relationships with Regulatory Agencies Act as the Primary contact with EMEA. Prepare team, manage, conduct and facilitate meetings with Regulatory agencies. Ensure that protocols are developed in alignment with regional registration strategies to support registration and labelling Ensure the timely MAA availability Responsibility for the submission and acceptance of MAA What are we looking for in our next Regulatory Affairs Consultant? Degree Educated in a Medical or Pharmaceutical discipline Possess a breadth of regulatory experience in drug development & commercialization Posses strong experience with EU regulatory procedures - CP, MRP Experience of working in Project teams My client is keen to get this position filled ASAP, so if you feel you have the skills, experience and desire to provide exceptional Regulatory Affairs experience, this is the opportunity for you! If you are interested in joining a well-established, internationally renowned, globally recognised organisation working with experts in their field, hit that apply button now! This advert was posted by Gold Group - one of the UK's leading niche recruitment consultancies. We span a variety of specialist industries and are the recruitment company to help you find your next career opportunity. We pride ourselves on our commitment to candidates and stick to our ethos of finding the right role for the right person. Services advertised by Gold Group are those of an Agency and/or an Employment Business. Please be aware that we receive a high volume of applications for every role advertised and regularly receive applications from candidates who exceed the job credentials. We will only contact you within the next 14 days if you are selected for an interview. Gold Group is an equal opportunity & diversity employer.