Törzskönyvezés, beadás, forgalomba hozatali engedély, termék életciklus, drug regulatory affairs
Your new company
We are looking for an experienced Regulatory Lead to handle global projects for our pharmaceutical partner.
Your new role
oversee the product lifecycle management activities of the company (mostly generic & biosimilar products); closely work together with regulatory teams within the company (with regards to Clinical Trial Applications, Marketing Authorisations, labelling, etc.) and represent & advocate Regulatory Affairs on strategic meetings
take part in the development of Regulatory Affairs strategies for new products, from early stages of development until lifecycle management
act as point of contact for competent authorities, including but not limited to EMA, national regulatory authorities and FDA; coordinate and lead communication with them
provide input from RA aspect to other departments within the company, as needed; provide supervision and professional support to RA colleagues as needed
track and follow up on EU and national regulations that might influence the effective life of products
What you’ll need to succeed
an MSc (or higher) degree in Life Sciences
at least 5 years’ working experience within Regulatory Affairs – worked with EMA, familiar with most processes
strong written and verbal English skills, fit for negotiation
ability to handle complex regulatory issues and prioritise activities; able to think strategically, consider multiple factors at once
project management and analytical skills; strong communication skills
What you’ll get in return
stable, well-established company, offering professional development and training
excellent benefits package – company car, medical services, insurance, etc.
focus on work-life balance and hybrid working conditions in the long run as well
What you need to do now
If you have the required professional background and interested in this role, click on the „Apply” button.
Talk to a consultant
Talk to Altmann Vivien, the specialist consultant managing this position, located in Budapest