Beschreibung
Junior GPRM/RegCMC Manager vacancy for a globally operating Basel based company in the pharmaceutical sector.Your experience/skills:
- Experience within the drug or biopharmaceutical environment, regulatory work experience is preferred
- Familiarity with chemistry and biotechnology analytics and pharmaceutical technology
- Knowledge of the drug development process is advantageous
- Capability to critically evaluate data from a wide range of scientific disciplines
- Strengths include strong interpersonal skills and good negotiation skills
- Academic degree the Science field like Chemistry, Pharmacy, Biochemistry, Biotechnology, Biology or any other equivalent education, an advanced degree is desirable
- Languages: English, fluent in written and spoken, German skills are desired
Your tasks:
- Authoring high-quality CMC documentation for HA submission, applying agreed CMC global regulatory strategies
- Assuring technical congruency and regulatory compliance as well as meeting agreed upon timelines and e-publishing requirements
- Preparing CMC responses to health authority questions during development, registration and product lifecycle
- Identifying the required documentation for global submissions and negotiating the delivery of approved technical source documents according to project time lines
- Participating as a member in the global team by contributing to the regulatory strategy as well as identifying the key issues and lessons learned
- Establishing and maintaining sound working relationships with partners and customers
Start:
Duration: 05MM+
Location: Basel, Switzerland
Ref.Nr.: BH17181
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.