компания "johnson & johnson" johnson & johnson (medical devices division) is looking for a strong candidate with communication and interpersonal skills, team-oriented for regulatory affairs specialist role based in moscow. main responsibilities: perform registration and certification/declaration processes for new innovative biological medicine according to eaeu procedure: planning of the submission strategy in cooperation with global regulatory affairs (gra), local functions (marketing, supply chain/planning, bq, pv, etc. in russia and cis) and regulatory director russia & cis; communication with different local and global functions on the eaeu regulatory requirements; preparation of dossier for submission according to eaeu requirements; execution and follow-up of all stages of eaeu re-registrations, starting from dossier submission up to registration certificate obtaining, including package materials and package insert leaflet preparation, normative document preparation, communication with ha, etc.; communication with regulatory contacts in gra for obtaining necessary documents and materials, negotiations in case of any specific cases/issues; ensure that relevant local issues are identified as potentially impacting ra strategy, and this risks are highlighted to gra and local team; perform registration and certification/declaration processes for medical devices: documents request from manufactures include working with manufacturers’ databases, share points or other manufacturers’ sources; registration dossier preparation; ensure timely registration of new product and obtaining of relevant licenses; review product registrations for accuracy and completeness of documentation; cooperation with outsourcing companies; responsible for accurate documentation of new products for submissions to authorities; local ra attendance; dossiers archiving; participation in gmp inspections; communication with regulatory contacts in hq and gra for obtaining necessary documents and materials, negotiations in case of any specific cases/issues;. develop relationships: participation in conferences and seminars organized by state authorities involving in registration process; requirements: higher education (pharmaceutical, general medicine, chemistry, biomedical) 2 + years of experience in regulatory affairs in pharmaceutical area is preferably eaeu legislation knowledge and in-hands experience will be a significant advantage knowledge of english language, sufficient for business communication purposes result-oriented, initiative, proactive team player good communication skills (collaborative approach), open-minded we offer: competitive salary & annual bonus medical and life insurance meal allowance fitness compensation mobile allowance opportunities for professional development and growth
Адрес
Москва