Regulatory Affairs Manager -CMC

Februar 2018

nicht angegeben

CH-Schweiz

nicht angegeben

13.02.2018

117307_1518516989

Projektbeschreibung
We are currently searching for a Regulatory Affairs Manager CMC to join a busy and dynamic team and support projects for new and marketed products.

The position is permanent and based in Geneva.

Your tasks:


Key tasks:

review and writing CMC documentation (CTD sections, IMPD or briefing books etc.) for Health Authority submissions for small molecules and biological products.

Manage global and regional submissions such as clinical trial applications, new marketing authorization applications, lifecycle management activities and responses to Health Authority questions.

Provide leadership on regulatory interactions on CMC related topics, lead preparation of meetings with regulatory agencies and ensure CMC regulatory issues impacting global regulatory strategy for proposed CMC filings are considered.

Proactively participate in design of global regulatory strategies for the development of therapeutic and diagnostic products in adherence to regulatory guidelines,

Represent Global Regulatory CMC on interdisciplinary project teams; partner with Regulatory, Quality, Research, Manufacturing, Nonclinical and Clinical teams - Assist during regulatory agency inspections.

Participate in regulatory intelligence activities; monitor regulatory guidelines and trends

Requirements:

Life science degree.

several years of experience in regulatory affairs role in the pharmaceutical/biotechnology/life science industry including both development and commercial pharmaceutical products

writing experience of CMC regulatory documents, proven participation to EMA CP application or FDA BLA.

Ability to work independently (with minimal supervision) as well as work in a team environment with changing timelines and priorities.

Demonstrated verbal and written communication skills.

Ability to multi-task, pay close attention to detail, and follow projects through to completion.
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