The Role:Perform conformance assessment between manufacturing documents and in-market dossiers filed with Europe and Emerging Markets Europe local Health Authorities, focusing on Module 3.Committed...
Develop regulatory strategy in conjunction with Clinical LeadCo-ordinate mock-up product information and packaging for products prior to marketing approval.Provide regulatory review and approval of marketing materialsTo coordinate changes for registered productsLiaise directly with EMA and similar regulatory bodiesEnsure appropriate change control is in place and executed for packaging changes Liaise with distributors, operations and purchasing etc regarding changesSupport regulatory filing activitiesSupport regulatory variations and communications with regulators/manage incoming questions etcSkills/Experience Required:
BSc. or MSc. in Pharmacy, Chemistry or related Science.Experience within Regulatory affairs functionExperience in local Regulatory Affairs/RegistrationUnderstanding of Sterile Manufacturing environment.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 589626
The 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.