Regulatory Biologics Consultant
Primary Responsibilities:Interact with global regulatory authorities (EMA and other EU/worldwide health authorities as necessary) to manage the lifecycle of on-market biosimilars. This involves the following areas:Marketing Authorisation Maintenance * Create global regulatory strategies relating to changes to marketing authorisations to support specified business needs. * Coordinate the preparation of initial applications to regulatory agencies and responses to agency questions according to required timelines following procedures. * Coordinate the submission of regulatory applications with Submission Management colleagues. * Liaise with regulatory authorities to facilitate the prompt review and approval of applications. * Follow company procedures concerning archiving of correspondence to and from regulatory agencies and recording submission related milestones in the company’s regulatory database. * Assist in the administration of Change Management Procedure, acting as change owner where appropriate.Periodic Safety Reports * Coordinate regulatory actions relating to the preparation/review of Periodic Safety Reports as required under the relevant SOP(s).Launch or Cessation of Marketing Notifications * Coordinate regulatory actions required upon launch or cessation of marketing as required under the relevant SOP(s)General * Develop and maintain constructive working relationship with Health Authority contacts. * Accountable for ensuring or contributing to Global Regulatory Strategies and implementation plans (including core labels, risk registers) developed for assigned project/s. * Ensures regulatory contributions achieve the objectives in the strategy, achieve agreed standards, and minimize resource demands while maximizing overall project delivery time and probability of success and facilitating post filing activities. * Ensures business compliance and implementation of and adherence to Regulatory standards.Skills & Qualifications: * Degree in Pharmacy, Biology, Chemistry, Pharmacology or related life sciences. If you are interested in this role or would like to have a confidential career discussion regarding other Regulatory Opportunities. Please contact me: or +441753 589673The recruiter has stated that all applicants for this job should be able to prove they are legally entitled to work in the EU/UK. SRG is a trading name of Science Recruitment Group Ltd an Employment Business/Agency.