Ardern Healthcare Limited is a rapidly-growing global specialty medical and pharmaceutical company with a unique combination of businesses focused on delivering the right medicine to the right patient at the right time to improve the quality of people’s lives around the world. The company consists of complementary businesses that focus on key areas of global medicine supply: clinical trial, unlicensed and licensed medicines. Our businesses can operate efficiently in a complex global regulatory environment and can ensure that precious medicines are delivered securely and effectively, wherever they are needed throughout the product lifecycle.
Ardern Healthcare Limited is a rapidly growing company that has a great future ahead. To sustain our growth we are always on the lookout for highly motivated, ambitious and committed individuals to join our highly successful team.
The role is responsible for regulatory submissions and maintenance of Global Marketing Authorisations for allocated projects
The Key responsibilities for this role are:
Regulatory responsibility for allocated projects on global licensed products within Ardern Healthcare Limited including applications for marketing authorizations in new territories, maintenance of existing licenses, variations to existing licenses, transfer of licenses to Ardern Healthcare Limited
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 Ardern Healthcare Limited professionally in external meetings in a variety of contexts (regulatory authorities, conferences, business meetings)
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 are able to fulfil 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 stakeholder (Regulatory Agency, external experts, etc.) to help achieve strategic goals and objectives
Develop and maintain effective external business relationships
Develop and maintain effective business relationships with key Ardern Healthcare Limited staff
Participate fully in the Company’s Personal Performance and Development process
Undertake training and development relevant to the job.
Adopt safe working practices in line with current Company procedures and to undertake appropriate training in Health and Safety
Keep up to date with and implement new legislation as and when required
The successful candidate will have the following:
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 followings: 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
If this role is of interest to you please send a recent copy of your CV to us and a member of the Talent Acquisition team will be in touch.
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