Manager, Regulatory Affairs

Job Summary

The Manager, Regulatory Affairs provides project representation and input to projects awarded to WCT for all stages of the drug development cycle and ensures the smooth running of the Regulatory Affairs Department.

Responsibilities

• 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
• Effectively communicate status of submissions with the Sponsor, Project Manager, CRAs, Medical Scientific Affairs staff
• Comply with SOPs, ICH GCP and national regulations as applicable
• Foster professional working relationships with internal and external contacts at the local and international levels to ensure expeditious submission/approval of regulatory dossiers
• Provide training, coaching and mentoring to junior members of staff, may be required to line manage junior members of staff
• Deputised for the Regulatory Affairs Director as required
• Perform other duties as assigned.
• The duties and responsibilities listed above are representative of the nature and level of work assigned and are not necessarily all-inclusive.

Other Skills and Abilities

• 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

Requirements

• Bachelors Degree in Chemistry or Life Sciences, Nursing or equivalent experience
• Previous experience within the pharmaceutical/CRO industry
• Promotion to the next level is not automatic based on years of experience.
• Personnel are evaluated on proven competency, level of responsibility, and ability to work independently.

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