Global Senior Director of RA/QA

JR United Kingdom; City Of London; On-site; GBP 90,000 - 140,000; Full time

Job summary

Une entreprise dynamique et en croissance dans le domaine pharmaceutique recherche un Directeur Senior Mondial en RA/QA pour diriger ses initiatives en matière de qualité et de réglementation. Le candidat idéal possédera une solide expérience dans les affaires réglementaires au sein de l'industrie biotech/pharmaceutique, ainsi que des compétences avérées en leadership et en communication. Ce rôle stratégique implique de travailler en étroite collaboration avec plusieurs départements pour garantir l'approbation rapide des produits et le respect des réglementations en évolution.

Qualifications

• Expérience forte dans l'Assurance Qualité/Réglementation dans le secteur Biotech / Pharmaceutique.
• Compréhension approfondie des réglementations globales (FDA, EMA, ICH).
• Compétences en gestion et leadership, mentorat d'équipe nécessaire.

Responsibilities

• Développer et mettre en œuvre des stratégies efficaces d'Assurance Qualité et de Réglementation.
• Gérer et encadrer une équipe de professionnels réglementaires.
• Coopérer avec des équipes transverses pour assurer la conformité réglementaire.

Skills

Leadership

Communication

Regulatory Affairs

Quality Assurance

Education

Bachelor's or advanced degree in a scientific or medical field

Job description

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Global Senior Director of RA/QA, london (city of london)

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Client:

Mantell Associates

Location:

london (city of london), United Kingdom

Job Category:

Other

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EU work permit required:

Yes

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Job Views:

3

Posted:

16.06.2025

Expiry Date:

31.07.2025

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Job Description:

Mantell Associates is partnered with a rapidly growing CDMO, who is looking to expand their team with the addition of a Global Senior Director of RA/QA.

Global Senior Director of RA/QA - Responsibilities:

• Develop and implement effective Quality Assurance & Regulatory strategies by maintaining Policy and Intelligence
• Manage and mentor a team of regulatory professionals, providing guidance and leadership to ensure adherence to global regulations and internal policies
• Be at the forefront of new and developing regulations and guidelines
• Collaborate with cross-functional teams, including clinical development, medical affairs, and quality assurance, to ensure regulatory compliance and timely product approval
• Responsible for providing an overview of QA/RA Policy to stakeholders and staff
• Monitor and interpret changes in global regulations and communicate the impact on the company's products and operations
• Ensure submission publishing is well executed and on time
• Engage and support all relevant staff to support M&A activities
• Proactively manage a Regulatory Affairs network externally and internally

Global Senior Director of RA/QA - Requirements:

• Bachelor's or advanced degree in a scientific or medical field
• Strong experience within Quality Assurance/Regulatory Affairs in the Biotech / Pharmaceutical space, including leadership experience
• Thorough understanding of global regulations (FDA, EMA, ICH) and their impact on product development and approval
• Strong leadership and management skills, with the ability to mentor and develop a team of regulatory professionals
• Excellent communication and interpersonal skills, with the ability to interact effectively with internal and external stakeholders
• Proven track record of Global Regulatory Processes

Mantell Associates is a specialist Pharmaceutical and Life Sciences headhunting firm. For more information on this role, please contact us at 44 (0)20 3854 7700.