Regulatory Affairs Manager

Clinigen is a rapidly growing global specialty pharmaceutical services business with a unique combination of services across the pharmaceutical lifecycle. We currently have over 1,000 employees headquartered in the UK with global offices in the US, EU (Belgium, Germany, France), Asia Pacific and South Africa. Clinigen is growing rapidly and is positioned well for an exciting future of continued expansion.

To support our growth, we are currently seeking a detailed orientated, collaborative and client facing Regulatory Affairs Manager. You will be responsible for regulatory submissions and maintenance of Global Marketing Authorisation's for allocated projects. You will provide support and advice relating to the regulation of Managed Access programs to internal customers and external Clinigen clients whilst providing support and guidance in the collection, interpretation and dissemination of Regulatory Affairs Intelligence.

Key Responsibilities:

Operational

• Regulatory responsibility for allocated projects on global licensed products within Clinigen Healthcare Ltd including applications for marketing authorizations in new territories, maintenance of existing licenses, variations to existing licenses, transfer of licenses to Clinigen
• Responsible for the provision of regulatory support for allocated Managed Access programs
• Responsible to support the development of regulatory strategies and provision of regulatory advice internally
• Represent Clinigen professionally in external meetings in a variety of contexts (regulatory authorities, conferences, business meetings)

Departmental

• Provide coaching and mentoring in specific areas of expertise to junior members of the department
• Ensure proper filing of regulatory submissions and correspondence either internally or via external contractors
• Create and maintain allocated SOPs for Regulatory Affairs

Regulatory Intelligence and Compliance

• Ensure that all regulatory activities comply with current Regulatory Agencies requirements and guidelines
• Assist in establishing and maintaining the Regulatory Intelligence repository for the supply of unlicensed medicines up to date.
• Ensure that Regulatory Intelligence updates are effectively communicated within the company to help ensure regulatory compliance and proper planning
• Proactively build/strengthen contact with external stakeholder (Regulatory Agency, external experts, etc.) to help achieve strategic goals and objectives

Requirements

• Bachelor's Degree (or preferably higher degree) in Life Sciences or scientific discipline
• Minimum 4 years’ experience within pharmaceutical industry/CRO.
• Ideally a minimum of 2 years in a client facing role
• Good knowledge of European Regulatory Affairs with experience in one of the following: clinical trials, MAA procedures, post marketing maintenance
• Demonstrate ability to deliver results to the appropriate quality and timelines
• Proven ability to successfully manage regulatory submissions
• Proven ability to provide advice and training in areas of regulatory affairs
• Excellent organizational and project management skills
• Outstanding written, verbal and interpersonal communications skills
• Excellent ability to handle multiple tasks in a fast-paced and constantly changing environment

Interested? We would love to hear from you, please apply today for consideration.