Zur Stelle:For our client, a Swiss global pharmaceutical group, based in the region zürich, we are looking for a highly motivated Regulatory Affairs Director 100 % to lead regulatory affairs activities for our new products.
• Lead the RA activities for innovative new products
• Be the primary contact for major topics related to Health Authority interactions
• Coordinate support from relevant internal GRA sub-functions, external consultants and vendors.
• Manage timelines and resources to achieve stated objectives, ensuring tracking tools and regulatory databases are maintained and up-to-date.
• Work in close collaboration with Partner Business functions to integrate all aspects of global regulatory strategy.
• Drive GRA contribution to establish and maximise potential of the product
• Ensure strategic submissions on plan
• Develop regulatory strategy to deliver Target Product Profile (TPP) label
• Provide regulatory input for differentiation versus current and future competition
• Ensure GRA delivery of LCM related activities
• Ensure that the interactions between Regulatory and other departments are managed optimally to enable achievement of program targets
• Contribute to the development and implementation of processes and procedures relevant to the operations of the regulatory function and its interactions with internal stakeholders.
• MBS, BA in a relevant scientific discipline, or BSN/BSc in Nursing. MA/MS or PhD in life sciences or chemical engineering, or PharmD preferred.
• At least 10 years’ experience in pharmaceutical regulatory affairs
• Direct experience interacting with national Health Authorities
• Excellent knowledge of the process for developing and launching products in the EU and internationally, including direct experience with the Centralised Procedure
• Fundamental understanding of the contents of product dossiers and critical attributes of medicinal products for registration
• Excellent verbal and written communication skills in English.
• Experience in leading a regulatory group or cross-functional team
• Prior involvement in US registrations or other registrations outside of the EU.
• Well known in regulatory community in the EU with good Health Authority contacts.
• Understanding and speaking German and/or French is a strong asset
Walter P. Hölzle is looking forward to receiving your application.
Per sofort oder nach Übereinkunft
Ausbildung / Erfahrung
Berufsleute mit mehrjähriger Erfahrung
Kontakt / Ansprechpartner
Hölzle, Buri & Partner Consulting
Schweiz / Kanton Zürich
Branche(n) / Rubrik
Chemie / Pharma / Kunststoff / Lebensmittelindustrie / Diagnostics - Regulatory / Regulatory Affairs Manager / Regulatory Affairs Officer
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4586 - 395864