Senior Regulatory CMC Manager
Posted on Sep 4, 2020 by RM IT Professional Resources AG
Senior Regulatory CMC Manager vacancy for a globally operating Basel based company in the pharmaceutical sector.
- Experience with drug and biopharmaceuticals, chemistry, biotechnology, analytics and pharmaceutical technology
- Knowledge of drug development process is advantageous
- Familiarity with evaluating data from a wide range of scientific disciplines
- Superb written and spoken communication plus negotiation skills along with a sense of effective planning as well as organizational and interpersonal skills
- Finished Degree in Chemistry, Pharmacy, Biochemistry, Biotechnology, Biology or a in a similar field, an higher or advanced Degree in either one of these is a plus
- Languages: English, fluent in written and spoken,
- Assisting with the implementation of global CMC submission activities like planning, authoring, reviewing, coordination and submission for assigned projects and products
- Leading, Managing and Formulating global CMC regulatory strategies focusing on innovation and maximizing the business benefit in balance with regulatory compliance
- Creating high quality strategic project documentations and presentations such as project plans, strategic documentation, lessons learned and more
- Preparing CMC responses to health authority question during the development, registration as well as product stages
- Working on first-class CMC documentation for HA submissions in regards of support and guidance, applying arranged CMC global regulatory strategies, assuring technical congruency and regulatory compliance while meeting agreed timelines and e-publishing requirements during the project life cycle
- Analysing and identifying required documentation for world-wide submissions and negotiating the delivery of approved technical source documents in accordance with project timelines
- Establishing and maintaining good and deep working relationships with partners an customers
Does this Spark your interest? Then take the next step by sending us your CV as a Word document and a contact telephone number on which you are reachable during working hours.
Going the Extra Mile.
As a preferred recruitment agency for Swiss banks, international insurances, finance service providers, software and pharma companies, we acquire exciting positions since 1998 in Zurich, Bern, Basel and other regions in Switzerland every day.
Due to work permit restrictions we unfortunately can only consider applications from EU or Swiss citizens as well as current work-permit holders for Switzerland.
New to Switzerland? In case of a successful placement, we support you with:
- All administrative questions
- Finding an apartment
- Health- and social insurance
- Work permit and much more
Thank you for your interest. By applying, you give us the permission to internally store and process your data for the application process. We strictly comply with the applicable data protection laws.