Manager, Regulatory Affairs

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Skills you'll use

What you'll do

• _Tasks may include but are not limited to:_
• Provide expert regulatory advice and contribute to regulatory project work
• Ensure accurate compilation, management and tracking of submissions
• Participate in business development activities preparing regulatory sections of proposals and feasibility reports, regulatory costing and budgets and attend bid defense meetings to meet business needs
• Develop department work practices and other company initiatives
• Liaise with the Regulatory Affairs Director to plan, organise, compile progress and submit regulatory submissions on a timely basis,
• Coordinate & manage regulatory & ethics committee submissions and maintain approvals throughout EMEA, Asia Pacific and Latin America regions
• Stay abreast of changing regulatory legislative requirements and ensure maintenance of the regulatory intelligence database
• Contribute towards the preparation of technical documentation such as IMPDs and IBs which may involve chemical, pharmaceutical, toxicological, pharmacological and clinical aspects of specified regulatory submissions
• Review and make recommendations on all relevant documentation e.g. labels, patient information sheets, diary cards etc…to ensure compliance with ICH GCP & country specific requirements

Who can apply

• Clearly, proven leadership and organizational management skills are essential attributes
• Strong planning, strategizing, managing, monitoring, scheduling, and critiquing skills
• Excellent written and verbal communication skills to clearly and concisely present information
• Strong interpersonal skills in a fast-paced, deadline oriented, and changing environment
• Excellent ability to handle multiple tasks in a fast-paced and constantly changing environment
• Ability to exercise sound judgment and make decisions independently
• Excellent self-motivation skills
• Proficiency in all MS-Office applications including Microsoft Word, Excel, and PowerPoint
• Expert knowledge of ICH GCP and the EU Clinical Trials Directive/National regulations (CTAs, Amendments, Urgent Safety Measures, End of Trial Notifications)
• Expert knowledge of drug development

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