Bionical Emas is the only CRO to combine Clinical Development, Early Access Programs and Clinical Trial Supply, delivering a unique, seamless approach to bring life-changing medicines to patients around the world. With clients, staff and offices around the globe, we offer a varied and international experience. Our clients range from smaller biotech’s to large global pharmaceutical companies, all with different needs and expectations. As a business, we have invested heavily in ensuring we have the systems, processes, and people, to deliver for the very varied requirements of our clients. The culture of Bionical Emas is friendly, flexible and supportive, where all staff are encouraged to grow, develop and exceed their expectations. The roleWe are looking for a Regulatory Manager to join our Clinical Development Regulatory team. The role is regionally based in the UK. This is an intermediate level role into the Regs Team, with potential to develop a career within Bionical Emas.
Main responsibilities• Manage day-to-day regulatory affairs activities to ensure compliance with regulatory obligations and requests• Provide advice on EU regulatory strategy and requirements for investigational and marketed products to pharmaceutical and biotechnology clients• Provide regulatory advice in support of global clinical study programmes with a particular emphasis on identifying areas for harmonisation of regional requirements• Lead/participate in specific projects as directed by the SVP Regulatory Affairs• Lead/participate in client meetings and liaise with clients regarding ongoing projects• Prepare, coordinate and review documents in order to support regulatory submissions for both investigational and commercial medicinal products• Liaise with regulatory authorities including the organisation of agency meetings and associated briefing materials• Ensure compliance with EU regulatory requirements including contribution to client and/or Bionical-Emas quality systems • Manage Bionical-Emas employees and vendors who are engaged in regulatory service activities on behalf of clients or Bionical-Emas
Key things we are looking for• Life Sciences Graduate/Drug Development Experience • Good Communication skills• Diligent team player, with Attention to Detail• Experience working in regulatory affairs either within a CRO environment (preferred) or within the pharmaceutical industry• Ability to work independently, or as part of a Project Team• Clinical Trial experience advantageous
Make a difference At Bionical Emas, we are committed to supporting our clients and our staff, so that they can bring life-changing medicines to patients around the world. Join Bionical Emas on our mission to make a difference.