Regulatory Affairs Regional Director (m/f) - Pharmaceuticals
Regulatory Affairs Regional Director will play a strategic role in the process of launching new products on the European market by regulatory affairs support including drug master file submissions, drug product dossier registrations and regulatory intelligence research. He or she will closely cooperate with HQ in China, management in Poland and other EU affiliates as well as company's strategic partners to review and approve documents for submission.
Client Details
Our Client is global player on the pharmaceutical market with the distinctive portfolio in cardiology field and strong pipeline in biosimilar products. The company has strong market presence in Asia & Pacific and US therefore a strategic decision has been taken to expand the European market with Poland as key country in further regional business development.
Description
- Perform scientific and technical oversight of development and regulatory documentation
- Ensure adherence to schedule for maintenance of approvals
- Liaise with the Agency, monitor the progress of regulatory submissions, respond to queries and ensure that registration approvals are granted without undue delay
- Serve as the Regulatory Affairs Subject Matter Expert for the EU business including evaluation of new and updated EU policies/guidelines
- Provide regulatory support during customer audits and regulatory inspections of the facilities in China
- Provide training to regulatory staff across the group
- Cooperate with other departments such as Manufacturing, Product Development, Quality Control and Quality Assurance
- Conduct regulatory due diligence including evaluation and review of documentation for compliance with product licenses
- Provide input into project plans pertinent to regulatory activities
- Work with regulatory contract partners in EU covering PV and lab testing
Profile
- Perform scientific and technical oversight of development and regulatory documentation
- Ensure adherence to schedule for maintenance of approvals
- Liaise with the Agency, monitor the progress of regulatory submissions, respond to queries and ensure that registration approvals are granted without undue delay
- Serve as the Regulatory Affairs Subject Matter Expert for the EU business including evaluation of new and updated EU policies/guidelines
- Provide regulatory support during customer audits and regulatory inspections of the facilities in China
- Provide training to regulatory staff across the group
- Cooperate with other departments such as Manufacturing, Product Development, Quality Control and Quality Assurance
- Conduct regulatory due diligence including evaluation and review of documentation for compliance with product licenses
- Provide input into project plans pertinent to regulatory activities
- Work with regulatory contract partners in EU covering PV and lab testing
Job Offer
- Great career prospects and chance to build a start-up company with possibilities to roll-out in the European Union
- Opportunity to work in an international environment with a real impact on the commercial decisions and input into planning and implementing strategies
- Attractive compensation package
- Entrepreneurship-like company culture
Location: Warsaw
Contract type: Na czas nieokreślony
About Michael Page
Michael Page is a leading professional recruitment consultancy specialising in the recruitment of permanent, contract and temporary positions on behalf of the world's top employers.
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