Norgine

About Norgine

Interim Principal Regulatory Affairs Executive - Austria, Germany and Switzerland Reporting to; Regulatory Affairs Manager - Austria, Germany and Switzerland Location; Wettenberg, Germany OR Vienna, Austria Tenure; Full time; Maternity cover MAIN PURPOSE: The Principal Regulatory Affairs Executive is responsible for preparing high quality documentation for all regulatory submissions; liaising with relevant departments to ensure regulatory requirements for these submissions are met; proactively communicating with regulatory authorities in order to expedite approval of these submissions in Austria Germany and Switzerland. The Principal Regulatory Affairs Executive may also be responsible for planning regulatory submissions, mentoring and/or supervising the work of junior Regulatory Affairs staff, and may be required to lead cross-functional project teams as required. KEY RESPONSIBILITIES & ACCOUNTABILITIES: To prepare and submit high quality documentation for all regulatory submissions, following current best practice standards To liaise with relevant internal departments and external contacts to ensure regulatory requirements for these submissions are met and to proactively communicate with regulatory authorities in order to expedite approval of submissions To provide regulatory advice and support to other areas of the Company To prepare and maintain product labelling for appropriate markets in cooperation with local regulatory and commercial contacts To coordinate changes in the registration texts and packaging material with all related tasks To anticipate and resolve complex regulatory issues To actively participate as primary regulatory resource in cross-functional project teams To prepare and review plans for submissions within agreed timelines and ensuring alignment with agreed strategy To identify and provide information for incorporation in the Regulatory databases as appropriate To provide information on expenditure against budget for inclusion in periodic financial reports To maintain the paper and electronic filing systems for assigned products/countries, following Records Retention procedures To interact with industry trade associations and external consultants as necessaryActing in a capacity on behalf of Norgine GmbH/ Wettenberg, Marpha GmbH/ Wettenberg, Germany; Norgine Pharma GmbH/ Vienna, Austria and Norgine AG/ Lucerne, Switzerland. Requirements: Ability to communicate clearly in German and English Good degree in a relevant life science subject or equivalent Considerable regulatory experience, specific local regulatory knowledge of Switzerland, Austria and Germany and general knowledge of worldwide regulatory requirements (including GMP, GLP and GCP) Proven expertise in Swiss regulatory requirements A full strategic understanding of the drug development principles and processes Awareness, understanding and an ability to interpret the ICH guidelines relevant to his/her technical/functional responsibilities, specifically those related to developing a Target Product Profile and delivering a product at the end of the development process Demonstrates an ability to analyse and summarise data to a high level Awareness of external regulatory environment Focuses on customer needs, follows up on commitments and requests Excellent interpersonal skills Excellent verbal and written communication skills Works cooperatively within a team and leads team as appropriate Able to work effectively without supervision

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Company Info

Legal Form: GmbH

Company Type: Private

Company Size: 51 - 250

Revenue: 100 - 500 billion (USD)

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Hiring Locations: 24

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