Senior GPRM/RegCMC Associate Director
Posted on Feb 12, 2021 by RM IT Professional Resources AG
Senior GPRM/RegCMC Associate Director vacancy for a globally operating Basel based company in the pharmaceutical sector.
- Expertise in regulatory development as well as submission and approval processes in major regions for drugs and medical devices preferably including digital devices
- In-depth knowledge of drug development with experience in leading teams in health authority negotiations and in making regulatory submissions
- Familiarity with working in a highly matrixed organisation across groups and divisions while managing expectations
- Practice with digital endpoint technologies such as SaMD, ePRO, eCOA and sensors for medical devices or consumer grade is preferred
- Strengths include leadership, communication, collaboration as well as writing and problem solving skills
- Degree in a science based discipline with essential experience and demonstrated capability, an advanced degree such as MD, Ph. D or PharmD is preferred
- Languages: English fluent in written and spoken, additional languages are an asset
- Representing an integral part of the RA Innovation group and ensuring compliance with global regulatory requirements as well as adherence to regulatory internal policies and processes
- Providing regulatory leadership on digital endpoint development in order to support drug development teams in alignment with company approach
- Developing high quality regulatory strategy and health authority engagement plans as well as supporting HA interactions, including preparing and finalising briefing books, rehearsals for HA meetings and responses to HA questions
- Assisting with key regulatory submissions including CTAs, INDs, 510Ks, PMA, IDEs, NDAs, drug dossiers and device clearance planning processes
- Identifying requirements, issues, gaps, and trade-offs affecting optimal and timely registration and clearance while providing input on the Development Core Data Sheet and Core Data Sheet for digital-technology supported drugs
Location: Basel, Switzerland
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.
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