Job Description

Our client a specialist in the pharmaceutical industry is currently recruiting a Regulatory Affairs Manager for their Centurion Office.

Purpose of the Job:

• Responsible for regulatory submissions and maintenance of Global Marketing Authorisations for allocated projects.
• Provide support and advice relating to the regulation of Managed Access programs to internal customers and external clients.
• Provide support and guidance in the collection, interpretation, and dissemination of Regulatory Affairs Intelligence.

Essential functions and responsibilities:

Operational

• Regulatory responsibility for allocated projects on global licensed products within the business including applications for marketing authorizations in new territories, maintenance of existing licenses, variations to existing licenses, and transfer of licenses to the business.
• Responsible for the provision of regulatory support for allocated Managed Access programs.
• Responsible for supporting the development of regulatory strategies and provision of regulatory advice internally.
• Represent the company 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.
• In case of line management responsibilities: Manage direct line reports and/ or external consultants. Provide the necessary training and support to ensure that they can fulfill their roles.
• 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 stakeholders (Regulatory Agency, external experts, etc.) to help achieve strategic goals and objectives.

Personal Development

• Develop and maintain effective external business relationships.
• Develop and maintain effective business relationships within the organisation.
• Participate fully in the Companys Personal Performance and Development process.
• Undertake training and development relevant to the job.
• Adopt safe working practices in line with current Company procedures and undertake appropriate training in Health and Safety.
• Keep up to date with and implement new legislation as and when required.

Required qualification and working knowledge:

• Bachelor's Degree (or preferably higher degree) in Life Sciences or scientific discipline.
• Minimum 4 years of experience within the 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 communication skills.
• Excellent ability to handle multiple tasks in a fast-paced and constantly changing environment.

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