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Regulatory Affairs Manager - Pharmaceutical Manufacturing at PE Global
London, United Kingdom
Job Descrption
• Acquire and maintain required approvals for clinical trials and marketing of medicinal products.
• Ensure timely regulatory compliance with approvals.
• Supervise regional regulatory leads and/or support staff as needed.
• Advise the Global Regulatory Team (GRT) on regional considerations in strategy development.
• Participate in various teams (GRT, GDT, CST, LWG, Regional Teams).
• Act as a contact with regulatory agencies and communicate outcomes to GRT and senior management.
• Participate in core regulatory activities and contingency planning.
• Review and approve promotional and non-promotional materials.
• Manage product lifecycle and distributor markets per national agency requirements.
• Plan and manage regulatory submissions for clinical trials and marketing applications.
• Implement product-related regulatory strategies and processes.
• Provide regulatory guidance on regional mechanisms to optimize product development.
• Collaborate on regional... product label development and support label negotiation activities.
• Advise on regulatory implications and requirements for global clinical development plans.
Requirements:
• Master's degree (scientific area).
• EU experience is essential, oncology experience would be ideal.
• Experience working with policies, procedures, and SOPs.
• Knowledge of relevant legislation and regulations relating to medicinal products.
• Awareness of the regulatory procedures in region for MAs, CTAs, post approval changes and amendments, extensions, and renewals.
• Knowledge of drug development and cultural awareness.
Please note PE Global cannot assist in sponsorship for any candidate. Any candidate applying to the role should have a valid visa to live and work within the UK for at least the next 12 months
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