Senior CMC Regulatory Manager - Pharmaceutical consulting company - Mu
Nr ref.: /JOBS.pl
We are on the market for over 10 years and work with international pharmaceutical clients across Europe. US, Asia and Australia providing them with the best quality consulting within regulatory affairs. In our company we have experts from preclinical development to post-marketing and full life-cycle management for drugs, combination products, borderline products and medical devices.
Our work would not be possible without our motivated employees with great professional and personal skills. Due to our constant development now we are looking for a senior CMC consultant who can work autonomous and within a team.
If this sounds appealing to you, please contact Aine Uusvel from Meet via email or via phone . The applications will be handled with discretion.
As Senior CMC Regulatory Affairs Manager you have the following tasks:
· Lead and advise strategic planning on CMC and regulatory affairs related topics
· MAA first/new launches (worldwide) and post-approval variations
· Response to authorities' deficiency letters
· Author, assesse and supervise CMC international regulatory documents:
· Create briefing packages for scientific advice meetings
· Provide project management and working group leadership
Ideally we are looking for candidates with the following qualifications:
· Extensive of experience within EU or global regulatory affairs
· Good CMC knowledge, experience with dossier writing
· German and English business fluent
· High client focus approach
Full job description and company details are available upon application, apply below. This position is being dealt by Aine Uusvel at Meet, please call on . You can also e-mail us directly at to discuss in confidence.
Meet are good people who are great at recruitment. We're proud to partner with the industries leading Pharmaceutical, Biotechnology, Medical Device, Marketing Communications and Contract Research Organisations (CROs) worldwide, helping them to find and secure the best global talent available. We pride ourselves on our open, friendly approach and are here to guide you through the recruitment process every step of the way.