Regulatory Affairs CMC Associate Manager


Premium Job From RM IT Professional Resources AG

Recruiter

RM IT Professional Resources AG

Listed on

14th October 2021

Location

Basel

Type

Contract

Start Date

15.11.2021

This job has now expired please search on the home page to find live IT Jobs.

Regulatory Affairs CMC Associate Manager vacancy for a globally operating Basel based company in the pharmaceutical sector.

Your experience/skills:Regulatory experience combined with experience in drug or biopharmaceuticals is preferredWorking knowledge of chemistry or biotechnology, analytics or pharmaceutical technologyAbility to critically evaluate data from a broad range of scientific disciplinesA thorough understanding of regulations, guidelines for NCEs and product life cycle maintenance as well as know-how of the drug development process is desirableDegree in Chemistry, Pharmacy, Biochemistry, Biotechnology, Biology or equivalentLanguages: English, fluent in written and spoken, German is beneficial

Your tasks:Authoring high-quality CMC documentation for HA submission, applying agreed CMC global regulatory strategies, assuring technical congruency and regulatory compliancePreparing CMC responses to health authority questions during development, registration and product lifecycleIdentifying the required documentation for global submissions and negotiate the delivery of approved technical source documents in accordance with project timelinesAnalyzing content, quality or timeliness issues with source documents, or any other potential authoring issuesContributing to the regulatory strategy, identifying the critical issues and lessons learned

Start: 11/2021

Duration: 12MM+

Location: Basel, Switzerland

Ref.Nr.: BH17642

Does this spark your interest? Then take the next step by sending us your CV 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 questionsFinding an apartmentHealth - and social insuranceWork 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.

You are currently using an outdated browser.

Please consider using a modern browser such as one listed below: