Global Program Regulatory Manager
Posted on Oct 13, 2021 by RM IT Professional Resources AG
Global Program Regulatory Manager vacancy for a globally operating Basel based company in the pharmaceutical sector.
- 4+ years of experience in regulatory and drug/biologic development spanning activities in Phases I-IV in the following areas: Innovation in regulatory strategy
- Experience in a global/Matrix environment or cross- functional teams in the pharmaceutical industry
- Hands on Experience in leading regulatory submissions and approvals in at least one major region
- Ability to achieve timely submissions/approvals and to adhere to regulatory requirements
- Strong knowledge of regulatory submission and approval processes in one or more major regions as well as experience in HA negotiations
- University degree with requisite experience and demonstrated capability, advanced degree such as MD, Ph D, PharmD is preferred
- Languages: English, fluent in written and spoken, Additional language is an asset
- Implementing regulatory strategy and managing operational activities for assigned regions as well as RFP across assigned regions
- Providing input into global regulatory strategy and contributing to Regulatory Functional Plan (RFP) and Seed Document, or their equivalents, including identificating of gaps or risks in global strategic plan for assigned regions
- Working with RA GPT representative or GTAL to plan and facilitate presentations to the Companies regulatory boards on regulatory strategy
- Developing and implementing regulatory readiness with other line functions and Country Pharma
- Functioning as Organizations and key opinion leader, and ensuring integration with global regulatory readiness with RA GPT representative or GTAL
- Leading rehearsals for HA meetings or with RA GPT representative and GTAL
Location: Basel, Switzerland
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.
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