Manager, Regulatory Affairs (m/w/d)

at  Astellas

Algemene informatie
Vacatureadvertentie
Manager, Regulatory Affairs (m/w/d)
Locatie
Duitsland
Functie/Business Area
Regulatory Affairs
Afdeling
Regulatory Affairs
Werkcategorie
Arbeidsovereenkomst voor onbepaalde tijd
Functiebeschrijving
Manager, Regulatory Affairs (m/w/d)

AUSBILDUNG/QUALIFIKATION:

Abgeschlossenes Studium der Pharmazie (Approbation als Apotheker/in) od. der Naturwissenschaften od. vergleichbar
Idealerweise mehrere Jahre Berufserfahrung in der Zulassung von Arzneimitteln

ESSENTIAL KNOWLEDGE & EXPERIENCE:

Relevant experience in drug approval, comprehensive knowledge of the associated processes and requirements.
Strong communication, influence, planning, and problem-solving skills enabling the establishment of close relationships with all relevant stakeholders.
Willingness and ability to collaborate in interdisciplinary and multicultural teams to ensure effective workflow.
Willingness to continuously undergo topic-related training to stay updated on the latest developments in the field and adhere to the legal and regulatory foundations.
Excellent proficiency in English, both written and spoken.

EDUCATION/QUALIFICATION:

Completed degree in Pharmacy (Pharmacist license) or in Natural Sciences or equivalent.

National Processes: Responsibility for the application and maintenance of approvals by conducting all national processes in the national, MRP-DCP, and central procedures, including variations, PSUSA procedures, risk minimization measures, renewals, and indication expansions.
Document Creation and Approval: In charge of creating, updating, and approving Summary of Product Characteristics (SmPCs), Patient Information Labelling (PILs), training materials, and mandatory texts in accordance with national and European regulations.
Artwork Management and Product Information Texts: Ensuring the initiation and approval of printed product information texts through Artwork Management, including proofreading and monitoring implementation in production.
Regulatory Review and Approval: Taking on the regulatory review and approval of product information and promotional materials in accordance with Astellas guidelines and the legal requirements of the country, including the German HWG.
Participation in Project Teams and Strategic Consulting: Actively participating in global and local project teams/brand teams to provide regulatory guidance and evaluation. Responsible for obtaining and modifying approvals, including launch preparations for new products or indication expansions. Close collaboration with RA-EMEA working groups and projects for successful study planning and implementation.