We are growing, grow with us! Are you looking for a dynamic company with daily new challenges and opportunities? Then, Pharmalex is your career opportunity. Pharmalex is one of the leading service companies for the Pharmaceutical Industry globally and is specialized in all aspects of drugs and medical devices approval, market development, and effective product maintenance.Manager Regulatory Affairs Your Job:General guidance (consultancy) of PharmaLex staff and customers regarding Regulatory Submissions & Labeling.Participation in the preparation, revision, and compilation of informative texts for healthcare professionals and patients (SmPC, PIL, Labeling).Presenting seminars and lectures PharmaLex-internally, for customers, and for professional audiences.Responsible for the planning, filing, and prosecution of approval projects.Creation, revision, editing, and maintenance of regulatory documentation.Planning and expediting approval projects using internally available or client-based software tools.Communication with the client and the Health Authorities.Coordination of project teams with internal and external staff and RegNet Partners.Contribution to optimizing departmental internal processes.Active contribution and distribution of department relevant expertise.If applicable, support in preparation, quotation, and invoicing for Regulatory Affairs Projects in close cooperation with the respective Team Lead.Your Profile:University degree in pharmacy or other natural sciences.Proven experience (+4 years) in evaluation, preparation, and compilation of quality documentation and/or experience in regulatory processes (registration procedures, renewals, variation procedures) with special emphasis on quality aspects.Ability to implement tactical goals of customer or internal projects within daily work.Structured, analytical, systematic, and independent manner.Capability of supervision, prioritization, and processing of parallel projects and tasks.High service orientation.Ability to manage internal and external (client) relationships on operational as well as client's team lead level.Excellent team player.Professional written and spoken communication skills with internal and external customers, colleagues, and supervisors.Experienced user of the MS-Office package, Adobe Acrobat, and database systems.English language fluency, written and spoken.Agencies only by prior agreement for the specific job opportunity.#J-18808-Ljbffr
