Descriptionlmw is seeking for an dynamic and experienced Regulatory Affairs Manager on behalf of its client, a leading pharmaceutical company based in Pallini.Responsibilities: Contributing to the accomplishment of the Regulatory Affairs function objectives Managing regulatory activities of the company In charge of technical assessments of projects (Auditing and Screening) and the ompilation of eCTD format Dossiers in cooperation with R&D Department Filling European submissions (DCPs, MRPs), supporting partners submissions and responding to deficiencies Managing the life cycle of the registration and post approval of the products Developing a knowledge of the RA on the development side of generics and added value medicines Communicating with the Authorities Across EU, MENA and other markets Reviewing and summarizing technical data for milestone assessments Handling of responses to DL’s liked to initial submissions, variations or renewals Preparing of m1 of the CTD dossier and compilation of modules 1-5 of the eCTD dossier (using specific eCTD software) Submission of eCTD dossier and relevant packages via specialized Common European Submission Portal Preparing of submissions including CMC variation filling Maintaining RA database for new and existing projects Requirements BSc Degree in Chemistry, Biology or relevant field (MSc and PhD shall be considered advantage) 7+ years of experience in Regulatory Affairs / CMC within a Pharmaceutical organization. Fluent in English with excellent MS 365/Office skills Knowledge of CMC and global regulatory guidelines Personal Assets: Effective communication and relationship management Team working spirit, capable of handling tasks efficiently and under minimal supervision Ability to work equally well independently or a member of a team Ability to deliver high quality work, in a timely manner and under specific deadlines BenefitsThe company offers competitive remuneration, private insurance and continuous learning and development opportunities within and a very dynamic and fast paced environment.Apply for this job