regulatory compliance expert in Corsier-sur-Vevey

posted
contact
Adrien Koralsztein, Randstad Merck Aubonne
job type
temporary
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job details

posted
location
corsier-sur-vevey, vaud
sector
administration
job type
temporary
reference number
129085-38963
contact
adrien koralsztein, randstad merck aubonne
phone
058 432 75 88

job description

Our client, a renowned biotech company, is looking for its future Regulatory Compliance Expert.

As part of the Site Regulatory Compliance group, you will support the site in the commercial registration process for new biotech products and major variations.

In this role you will coordinate the site review of quality (CMC) sections. You will also support the site in the timely answer to the questions from the Health Authorities (FDA, Japan PMDA, EMA…), in collaboration with the Global Regulatory Affairs functions.

qualification

•Degree in a Life Science or related discipline (minimum MSc or equivalent degree), higher degree preferable (e.g. PhD in a scientific discipline)

•You have at least 3-5 years of experience in the pharmaceutical industry

•You have at least 3-5 years of experience in global CMC regulatory affairs, and quality assurance / compliance

•Experience with life-cycle management activities in at least two regions (e.g. Europe, USA, or International)

•Experience in preparation and management of regulatory documentation, normally a full international submission (new product application) or a large variation

•Good knowledge in biotechnological sciences, manufacturing of biologics and related regulatory guidelines (cGMPs, 21 CFR, etc.)

•Able to search, understand and interpret regulatory intelligence information

•Autonomous, highly adaptable, able to collaborate and deliver in a matrix environment

•Excellent written and spoken communication skills in English

If you recognize yourself in those lines, don't wait a minute and apply to your next opportunity!