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REGULATORY AFFAIRS PROJECT MANAGER
Référence :

550

Lieu :

Non précisé

Descriptif :

We are looking for REGULATORY AFFAIRS PROJECT MANAGER in order to further advance towards our goal of positioning Servier as a significant and dynamic player in Oncology.

Internationally recognized for our expertise in Cardiology, Rheumatology and Diabetes Therapeutic Areas, we decided in 2014 to focus on the reinforcement of our Oncology effort, to contribute in a major way to the fight against Cancer. Consequently, we decided to dedicate 50% of our Research efforts (which represent 25% of our global turnover) to Oncology and more precisely in the areas of immune-oncology, apoptosis and cancer cell signaling.

To succeed in that exciting challenge, we are looking for highly motivated TALENTS!

The Regulatory CMC team is currently hiring a project leader with biologics regulatory CMC experience and good knowledge on current regulatory guidelines.

You will be responsible for global CMC submission activities in biologic field (cell therapy, genic therapy), especially for oncology drug. You will drive regulatory strategy for projects under development or marketed products, including identifying required content to ensure compliance.

You will represent Global Regulatory CMC on interdisciplinary project teams and take part into transverse projects on pharmaceutical and industrial development in close collaboration with structures in charge of product development and manufacturing.

Pharmacist, PHD, or engineer, you have strong experience with:
• The different techniques used during the development of new biologics drugs
• Writing the quality part (Module 3) of Marketing Authorization Applications (MAA) registration files or prepare the Investigational Medicinal Product Dossier ( IMPD) or Investigational New Drug ( IND)
• Preparing Chemistry Manufacturing and Control (CMC) documentation for Health Authorities submission, and the answers to the questions from Heath Authorities

- You are perfectly fluent in English and have strong communication skills as you will interact with internal and external Partners

Join us NOW!

About Servier
Joining Servier means working in a stimulating environment and contributing to an innovative, research-based and people-oriented organization.
Servier is the leading French independent pharmaceutical company, located in 144 countries with 21 000 employees and a turnover in 2015 of about 4 billion euros.
25% of Servier’s annual turnover is reinvested in Research & Development, reflecting the company’s dedication to its mission of innovation and discovery for improved treatment of unmet medical needs.

Organized as a foundation, we guarantee our independence from the stock exchange. As our late founder Doctor Jacques Servier said: “a company is a group of human beings, so it has no price”.
Servier is well known for its attention to the wellbeing of the staff, with particular importance placed on career evolution within the Group, and to an agreeable and productive working environment.

To know more, visit www.servier.com

About Servier Oncology
Our journey in oncology started in the 90s with Muphoran, a chemotherapy drug used to treat melanoma. In 2014, we launched Pixuvri in multiple relapsed or refractory aggressive non-Hodgkin B-cell lymphomas. On April 27th, 2016, we received marketing approval for LONSURF® (trifluridine/tipiracil) in the field of advanced metastatic colorectal cancer.

Currently, there are eight new molecular entities in clinical development for oncology respectively in breast, lung and other solids tumors as well as various leukemias and lymphomas.

This portfolio of innovative cancer treatments is being developed with various partners worldwide, and includes different class of anti-cancer drugs such as cytotoxics, kinase inhibitors, apoptosis inducers, immune and cell therapies.

To know more, visit http://servier-oncology.com

To apply and for more details about the positions (ref.550) :marie-caroline.de-langlais@servier.com

Contact :

SERVIER
 






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