Työnimike: Regulatory Officer

Työnkuvaus:
Description of unit: Regulatory compliance-team belongs to Project management and regulatory affairs-platform in Research and Development. Regulatory compliance team's major task is to take care of regulatory affairs of Orion's specialty products in lifecycle management phase but team member's assist also development phase submissions in all business areas. In addition, regulatory compliance team gives instructions and participates in the development of Orion regulatory database. Description of position: Main task is keeping Orion regulatory database up-to-date and produce database lists as needed. You will also compile marketing authorization documents, write administrative documents, prepare, review and do submission of marketing authorization application documents. You will be doing archival of original Orion documents (e.g. GMP certificate, CPPs, manufacturing authorization, trade register), and copy and distribute the documents as needed. Your duty is to take care of notarization and legalization of official documents in the public notary and embassies as needed. Furthermore, independent coordination of head office originated tasks in subsidiaries, CROs, and suppliers is expected. You will assist in cross-functional working process development projects and assist regulatory affairs organization in audit preparations. Requirements: We expect you to have process-oriented thinking, interest in working cross-functionally and have good collaboration skills. Ideally, you should have both a company-wide view, but to be able to work accurately and pay attention to details. Experience in regulatory affairs is needed, as well as basic knowledge of project management and regulatory databases. Personal skills include time management and personal leadership. Good written and spoken English are also a prerequisite. We offer: We offer you a possibility for a demanding but independent work with a wide view to various internal and external organizations. Supportive working environment and training as needed. We build well-being - together we do work that we are proud of!

Työnantajan nimi: Orion-yhtymä Oyj Orion Pharma

Työnantajan osoite: 02100 ESPOO

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Työn lyhyt kuvaus: Systeemisuunnittelijat

Maa: Suomi

Alue: Helsinki-Uusimaa

Sopimuksen kesto: Tilapäinen

Sopimuslaji: Kokopäiväinen

Lähde työtarjous:
MOL/Työ- ja elinkeinoministeriö, Julkiset työvoimapalvelut, Suomi