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Kategorie:

Regulatory Manager

Alternativen:
Regulatory Manager
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Regulatory Manager

medizin pharmakologie

Sonstiges



Our client is a successful medium-sized pharmaceutical group located in southern Switzerland. Its major strategy focuses on the development and registration of innovative pharmaceutical products, like Cancer Supportive Care, etc. To reinforce its Research and Development Department team, we are currently looking for an experienced:


Regulatory Manager


Responsibilities include:

- Provide scientific and strategic regulatory advice on development programs
- Review CMC, clinical and preclinical reports and other key technical documents
- Write and compile regulatory submissions
- Implement registration procedures
- Interact with regulatory authorities worldwide
- Manage the regulatory aspects of product’s life cycle
- Interact with other internal functions (preclinical, clinical and statistics, drug safety, manufacturing, business development, strategic marketing) providing regulatory inputs
- Interact with regulatory consultants

The successful candidate will ideally have the following qualifications:

- Strong scientific background (e.g. University Degree in Chemistry, Pharmacy, Biology)
- At least 10 years of relevant international regulatory experience within a pharmaceutical company, a
- regulatory Agency or a CRO
- Significant experience of interactions and negotiations with Agencies worldwide (FDA, EMA, PMDA, etc.)
- People management skills
- Flexibility, autonomy and a high level of initiative
- Fluency in English
- Good computer skills in Windows environment
- Knowledge of the e-CTD environment
- Willingness to travel internationally

Offered:

- attractive working and salary conditions
- pleasant working environment in a highly motivated team
- a long term career perspective

If you feel you fulfill the requisites please send your CV in English to recruiting@helvetia-hr.com For more information please don’t hesitate to contact: Ms Julija Ivanova at + 41 76 422 7595 Helvetia Medicum GmbH Personnel International AG Badenerstrasse 760, 8048 Zürich Tel. +41 43 811 72 48 Fax +41 43 811 72 49
Email: julija.ivanova@helvetia-hr.com

  Arzt algemeinmedizin (100%) || Arzt/Ärztin Allgemeinmedizin oder  




Our client is a successful medium-sized pharmaceutical group located in southern Switzerland. Its major strategy focuses on the development and registration of innovative pharmaceutical products, like Cancer Supportive Care, etc. To reinforce its Research and Development Department team, we are currently looking for an experienced: Regulatory Manager Responsibilities include: - Provide scientific and strategic regulatory advice on development programs - Review CMC, clinical and preclinical reports and other key technical documents - Write and compile regulatory submissions - Implement registration procedures - Interact with regulatory authorities worldwide - Manage the regulatory aspects of product’s life cycle - Interact with other internal functions (preclinical, clinical and statistics, drug safety, manufacturing, business development, strategic marketing) providing regulatory inputs - Interact with regulatory consultants The successful candidate will ideally have the following qualifications: - Strong scientific background (e.g. University Degree in Chemistry, Pharmacy, Biology) - At least 10 years of relevant international regulatory experience within a pharmaceutical company, a - regulatory Agency or a CRO - Significant experience of interactions and negotiations with Agencies worldwide (FDA, EMA, PMDA, etc.) - People management skills - Flexibility, autonomy and a high level of initiative - Fluency in English - Good computer skills in Windows environment - Knowledge of the e-CTD environment - Willingness to travel internationally Offered: - attractive working and salary conditions - pleasant working environment in a highly motivated team - a long term career perspective If you feel you fulfill the requisites please send your CV in English to recruiting@helvetia-hr.com For more information please don’t hesitate to contact: Ms Julija Ivanova at + 41 76 422 7595 Helvetia Medicum GmbH Personnel International AG Badenerstrasse 760, 8048 Zürich Tel. +41 43 811 72 48 Fax +41 43 811 72 49 Email: julija.ivanova@helvetia-hr.com


tags: sonstiges regulatory manager medizin pharmakologie


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