Chef de Partie (m/w) 100%

Regulatory Affairs Director 100 % - Stellenbeschreibung 395864

Stelleninserat von Hölzle, Buri & Partner Consulting

04.11.2020 / Arbeitsort: Region Zürich


Telefon: 041 727 67 87
Jobs in Region Zürich


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.


Stellenbeschreibung

Key responsibilities

• 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.

Requirements

• 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.


Antrittsdatum

Per sofort oder nach Übereinkunft


Ausbildung / Erfahrung

Berufsleute mit mehrjähriger Erfahrung


Kontakt / Ansprechpartner

Hölzle, Buri & Partner Consulting
Baarerstrasse 2
6300 Zug

Diese Stelle betreut: Walter P. Hölzle
041 727 67 87
Mail


Website

Region(en)

Region Zürich

Schweiz / Kanton Zürich


Branche(n) / Rubrik

Chemie / Pharma / Kunststoff / Lebensmittelindustrie / Diagnostics - Regulatory / Regulatory Affairs Manager / Regulatory Affairs Officer


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