Regulatory Affairs Professional (closed)
Regulatory Affairs Professional - my client is seeking a regulatory professional to join their team at either Associate or Senior Associate level. This great opportunity has become available at top innovator pharmaceutical organisation in the Neurosciences and Cardiovascular therapy areas. This is a diverse regulatory affairs role which will afford you with experience across the product life cycle, including the opportunity to develop your strategic drug development experience, new MAA filings as well as life cycle maintenance of the established portfolio.
Responsible for gaining regulatory approvals, supporting and maintaining marketing authorisations , line extensions, new formulations and Health Authority responses. The successful candidates will provide regulatory support for all assigned pharmaceutical products for all countries in the European, Middle East, Africa and West Asia (EMEA) region.
You will provide regulatory support and advice to the commercial divisions. Liaise with Global R&D and affiliate departments on regulatory issues, as well as European commercial, Medical Affairs and pricing and reimbursement groups.
You will keep abreast of emerging legislation and highlight the potential impact on the business.
Providing operational support to Global or regional based project teams, the ideal candidate will bring to this role a high level awareness of the EU and broader EMEA regional regulatory environment. Your expertise in your own particular specialism will be second to none and will help you devise regulatory strategies and technical solutions to keep the company ahead.
The successful candidate will have some regulatory experience gained in either pharma, generics or CRO environment but the capacity to learn is most important for this position.