A global clinical stage Biotech are looking are looking to expand their Regulatory affairs team in Germany.
Looking at novel therapy's in their therapeutic area, they have attracted interest of key pharma players for collaborations and partnerships. In this role you will gain exposure to many Regulatory aspects and beyond!
This role is great for someone who has scientific curiosity and team spirit mentality, as you will be expected to contribute on global project teams and not be afraid to let your voice be heard.
In this role, you will be advising other departments on Global Regulatory guidelines, ensuring smooth communication during pivotal development stages. You will be responsible for the writing and compilation of RA submissions including IND, CTA and BLA's.
3 years in Regulatory Affairs
Innovative product experience is essential
Strong knowledge and understanding of EMA and FDA regulations in Clinical Development
Biologic experience is preferred
Open minded and team spirit mentality
Able to navigate in a dynamic environment