Global Program Regulatory Manager (GPRM), Oncology


Premium Job From RM IT Professional Resources AG

Recruiter

RM IT Professional Resources AG

Listed on

4th May 2021

Location

Basel

Type

Contract

Start Date

asap

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

Global Program Regulatory Manager for a globally operating Basel based company in the pharmaceutical sector.

Your experience/skills:2+ years of regulatory experience, spanning activities in early development and Phase I-IV, preferably with a strong knowledge and regulatory operational expertise of EU regulatory affairs- additional knowledge of other regions is an assetScientific knowledge and any additional drug development experience in discovery research, CMC, preclinical pharmacology, toxicology, clinical development or other experimentally based disciplineOutstanding interpersonal, communication, negotiation, problem solving skills and ability to work in a global environmentAdvanced degree in a related scientific field with requisite demonstrated experience and capabilityLanguages: English, fluent in written and spoken

Your tasks:Providing input into global regulatory strategy for early development compoundContributing to regulatory innovations, such as novel therapeutic approaches, indications or endpoints, or any innovative regulatory pathwaysHelping with identifying regulatory issues, gaps, and tradeoffs affecting optimal and timely submission and approvalWorking in a high-performing multi-disciplinary Team to ensure submission of Clinical Trial Applications (CTAs) and Investigational New Drugs (INDs), and CTA/ IND related maintenance activities such as amendments, annual safety reporting, Investigator BrochuresParticipating in regulatory activities in planning early Health Authority (HA) interactions and in negotiations with HA to address queries on INDs and CTAs

Start: 06/2021

Duration: 09MM+

Location: Basel, Switzerland

Ref.Nr.: BH 16970

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 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: