Head of International Regulatory Affairs and Compliance
Vor 6 Tagen
We are seeking a highly experienced and skilled Head of International Regulatory Affairs and Compliance to join our team at Ironwood Pharmaceuticals. This is a critical role that will lead our global regulatory strategy and ensure compliance with all applicable regulations.
Key Responsibilities- Develop and Implement Regulatory Strategy: Develop and lead the implementation of regulatory strategies for assigned projects and products across all phases of product development, ensuring timely development of regulatory strategy and operating plans.
- Lead Cross-Functional Teams: Participate in or lead departmental and cross-functional task forces and initiatives, demonstrating ability to anticipate risks and develop solutions to identified risks.
- Regulatory Intelligence and Compliance: Monitor and share regulatory intelligence, ensuring compliance with all applicable regulations and guidelines.
- Team Management: Directly manage a team of regulatory affairs experts, overseeing functional budget and ensuring effective team performance.
- Stakeholder Management: Communicate with internal and external stakeholders, including members of the leadership teams, to ensure cross-functional alignment and effective collaboration.
- Project Management: Plan and direct projects, providing technical background, inspiration, leadership, and consultation to cross-functional colleagues and members of the global regulatory project team.
- Regulatory Input: Provide regulatory input to patient-centered outcomes research, market access/HTA strategy and submissions.
- Regulatory Affairs Expertise: Demonstrate a solid understanding of current EU regulations and guidance, political and legal climate, and industry practices to assist in meeting organizational goals.
- Education: Master's degree in a science field such as Biology, Chemistry, or Pharmaceutical sciences.
- Experience: At least 15+ years of pharmaceutical industry experience, inclusive of 10 years of global Regulatory Affairs experience or a combination of 8+ years of global Regulatory Affairs and related experience.
- Track Record: Demonstrated recent successful Regulatory Affairs track record in the development, submission, and registration of new drugs (biologics, innovative medicines, drug/device combination products, etc.) in the EU and international countries.
- Skills: Strong working knowledge regarding the selection, development, and evaluation of Clinical Outcome Assessments (COAs), as well as excellent leadership abilities and communication and interpersonal skills.
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International Regulatory Affairs Director
Vor 6 Tagen
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Regulatory Affairs Director
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Basel, Basel-Stadt, Schweiz Stratpharma AG VollzeitStratpharma AG, a rapidly expanding pharmaceutical company, is seeking a highly skilled Global Regulatory Affairs Associate to join their dynamic team. This is an exciting opportunity to be part of a company that is experiencing significant growth and expansion globally.This is a highly successful company with a strong track record of innovation and...
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Quality and Regulatory Affairs Manager
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Basel, Basel-Stadt, Schweiz Stratpharma AG VollzeitStratpharma AG, a leading pharmaceutical company, is seeking a highly skilled Quality Assurance and Regulatory Associate to join their team. This is a challenging global role that will work closely with the International Quality Assurance and Regulatory Director in managing the company's global quality assurance and regulatory functions.This is a highly...
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Director Regulatory Affairs, E
vor 4 Wochen
Basel, Basel-Stadt, Schweiz Proclinical VollzeitProclinical is seeking a dedicated and experienced Director of Regulatory Affairs. This role involves hands-on regulatory activities for a range of products, with the aim of achieving successful registration and life-cycle management. The successful candidate will provide operational and strategic regulatory input to cross-functional teams, ensuring...
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Global Head of Quality Operations
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Global Regulatory Compliance Specialist
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Head of Clinical Operations and Strategy
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Basel, Basel-Stadt, Schweiz BeiGene VollzeitJob DescriptionAbout the RoleThe Senior Manager of GMP/GDP Quality Compliance will play a critical role in ensuring the regulatory compliance status of BeiGene and its vendors. This position requires a strong understanding of global regulatory and health authority requirements, as well as excellent communication and interpersonal skills.Key...
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Regulatory Compliance Specialist
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Head of Clinical Operations and Strategy
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Quality Assurance and Regulatory Associate
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Basel, Basel-Stadt, Schweiz Stratpharma AG VollzeitStratpharma AG, a leading pharmaceutical company, is seeking a highly skilled Quality Assurance and Regulatory Associate to join their team. This is an exciting opportunity to work closely with the International Quality Assurance and Regulatory Director in managing the company's global quality assurance and regulatory functions.This is a highly successful...
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Director of Quality Assurance and Compliance
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Executive Director of Quality Management
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Director of Quality Assurance and Compliance
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Basel, Basel-Stadt, Schweiz Visonio Consulting GmbH VollzeitJob DescriptionJob Title: Director of Quality Assurance and ComplianceCompany: Visanio Consulting GmbHLocation: Basel, SwitzerlandJob Type: Full-timeIndustry: Building Automation, Sensors, and Software SolutionsAbout Us: Visanio Consulting GmbH is a leading provider of innovative solutions in the field of building automation, sensors, and software. We are...
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Basel, Basel-Stadt, Schweiz Randstad (Schweiz) AG VollzeitJob DescriptionWe are seeking an experienced Head of Quality Assurance and Management Technology to oversee the quality assurance and control for hardware and software products.The ideal candidate will be responsible for ensuring compliance with European and international standards, managing quality processes across the product lifecycle, and leading a...
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Basel, Basel-Stadt, Schweiz Randstad (Schweiz) AG VollzeitJob DescriptionWe are seeking an experienced professional to lead our quality assurance and management technology team. The ideal candidate will have a strong background in quality management and a proven track record of ensuring compliance with European and international standards.The successful candidate will be responsible for overseeing the quality...
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Global Program Clinical Head
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Section Head of Process Chemistry and Catalysis
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Basel, Basel-Stadt, Schweiz Roche VollzeitAbout the RoleWe are seeking a highly experienced and skilled Section Head of Process Chemistry and Catalysis to lead our Process Chemistry & Catalysis department within the Synthetic Molecules Technical Development team at Roche.Key ResponsibilitiesLead a team of scientists and associates responsible for end-to-end process chemistry, from route design to...
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Head of Analytical Sciences
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Basel, Basel-Stadt, Schweiz Roche VollzeitAbout the RoleAt Roche, we are committed to developing innovative therapies that improve the lives of patients. As a key member of our team, you will play a critical role in driving the development of safe, effective, and innovative biopharmaceuticals.Key ResponsibilitiesLead a high-performing team of analytical scientists and technicians, providing guidance...
