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Regulatory Science Vice President

Genève - GE - 1202

Regulatory Science Vice President

Qualifications
Ph.D. or advanced degree in life sciences & significant scientific and management work experience in a highly technical regulated sector.

Professional experience
Significant scientific and management experience in a highly technical regulated sector, including direct experience in the US FDA GxP total quality management environment. Experience in strategic development of regulatory science proposals, design and conduct of GxP development programs, preparation of written submissions for and interaction with US FDA. Project management experience in a matrix organization developing tobacco and/or emerging tobacco products.

Diplomas and education
Ph.D. or advanced degree in life sciences.

Linguistic and computer skills
Excellent level of English

Behavioral skills
Get Things Done, Empower People, Challenge Status Quo, Act Responsibly

Objectives of the position
The US Food and Drug Administration (FDA) is implementing significant new regulations for ENDS, Reduced Risk and Conventional Products based on scientific approaches, standards and processes developed for food, pharmaceutical and medical devices over the past 35 years. These significantly increase the complexity, standards and scope of work needed for product evaluation leading to approval to market in the US. If not properly addressed, these will become barriers to maintaining the current portfolio and introducing any new or modified products into the US. FDA’s systematic scientific approach is substantially influencing product standards, time-to-entry and competition in the marketplace, and is shaping expectations of tobacco regulators globally.

Objectives of the position
The US Food and Drug Administration (FDA) is implementing significant new regulations for ENDS, Reduced Risk and Conventional Products based on scientific approaches, standards and processes developed for food, pharmaceutical and medical devices over the past 35 years. These significantly increase the complexity, standards and scope of work needed for product evaluation leading to approval to market in the US. If not properly addressed, these will become barriers to maintaining the current portfolio and introducing any new or modified products into the US. FDA’s systematic scientific approach is substantially influencing product standards, time-to-entry and competition in the marketplace, and is shaping expectations of tobacco regulators globally.

Responsibilities
The purpose of this position is deliver regulatory science expertise supporting JTI’s growth and development plans for ENDS and Reduced Risk Products in the US, and more specifically to:
Develop and broaden JTI’s senior scientific presence, network, preparation and engagement with FDA to advance corporate and regional product initiatives in the US;
Drive and support regulatory science programs to meet strict new FDA requirements for ENDS, Reduced Risk, Nicotine Replacement Therapy (NRT) and Conventional Products;
Provide senior regulatory science expertise and engagement to JTI`s HQ and regional entities, essential to progress product initiatives in FDA’s technical and process-driven environment; and
Oversee corporate programs to ensure compliance with FDA`s developing regulation and standards affecting design, development and testing of ENDS and reduced risk products.

This position works collaboratively with SRA, Reduced Risk Products, HQ and regional functions, and the market - based on JTI’s corporate initiatives and priorities - to fulfill regulatory science requirements for evolving ENDS and RRP products evaluation and compliance leading to pre-market approval by the FDA.

About JT International
JTI is a leading global tobacco company operating in over 120 countries worldwide. One of the fastest growing international industry players over a ten year period, we market world-renowned brands such as Winston, Camel, Mild Seven, LD, Sobranie and Glamour.

Location : Geneva
References announcement : Fanny Givel
Contact applications : Fanny Givel : fanny.givel@jti.com
Visit : 9
Stellenangebot Details
Arbeitsort 1202 Genève
Fachbereiche
Organisationsbereiche
Funktionen
Ausbildung
Anstellungsart
Arbeitspensum 100%
Stellenantritt 09.01.2019
Stellenanbieter
JT International SA

Merryweather Laurie
Rue Kazem-RADJAVI 8
1202 Genève

Kontaktdaten

Merryweather Laurie
laurie.merryweather@jti.com

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