Senior Regulatory Affairs Specialist

We have an exciting opportunity to work for an international organization leading the way in product development and regulatory consulting. You'd be joining an innovative, well-known company with a breadth of expertise across the regulatory space. As a Senior Consultant/ Specialist, you are responsible for supporting client projects in the realm of 'Clinical Regulatory Activities' please see below for more info:Responsibilities:Provide strategic, technical, and regulatory advice/services in the area of clinical development of medicinal products, across a wide range of therapeutic areas.Offer support/advice across a broad range of regulatory activities Produce drug development plans, data gap analyses, and international regulatory strategies from a Clinical perspective.Contribute to technical authorship and review of development regulatory documents.Lead multi-jurisdiction programs of work and deliver consulting services within your respective area of expertise Represent in regulatory agency interactions and provide regulatory solutions to agency objections Requirements:MSc degree or higher in a life sciences10+ years in drug development and regulatory affairs Expertise in authoring and reviewing of regulatory documents; development regulatory documents; Regulatory Strategy Plans, Clinical and Drug Development Plans, Clinical Trial Applications, Pre-INDs, INDs, Scientific Advice and Meeting Briefing Documents, Orphan Drug and Paediatric plans/applications, Protocols, Investigator Brochures, IMPDs, CSRs, Marketing Authorisation Applications, New Drug Applications, Biologic License ApplicationsExperience in negotiation with multinational regulatory authorities including, as a minimum, European, UK, as well as US authorities.