Clinigen Group plc is a rapidly-growing global specialty pharmaceutical and services 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 Group consists of five synergistic businesses focused in three areas of global medicine supply: clinical trial, unlicensed and licensed medicines. Our group of complementary 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. Through five businesses, Clinigen Clinical Trial Services, Idis Managed Access, Idis Global Access, Link Healthcare and Clinigen Specialty Pharmaceuticals, we provide patient access to our own and other pharmaceutical companies’ products, whether to meet unmet medical needs or for use in clinical trials. We are currently 500+ people, headquartered in Burton-on-Trent in the UK, with offices in London, Weybridge, Surrey, the US, Australia, China, Japan, South Africa and Singapore. With a customer services team who speak over 19 languages between them, our clients from all over the world find us easy to do business with, while physicians and pharmacists find us a valuable source of information about how to access the medicines they need for their patients.
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 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)
- 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 Clinigen Group 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 upload a recent copy of your CV and a member of the Talent Acquisition team will be in touch.