Global Regulatory Team Lead
Pioneering the development and delivery of transformative therapies for over 30 years, evolved from a tiny start-up with just a handful of employees to one of the worlds leading biotech companies.
As a Global Regulatory Team Lead you will be responsible for provide Global Regulatory Strategy.
- Management and conduct of the Global regulatory activities for assigned projects in line with regulatory requirements.
- Preparing, compiling, reviewing and processing the regulatory submissions including both pre-approval and submissions such as Clinical Trial Applications (CTA)/Investigational New Drug (IND), amendments, annual reports, study protocols, study reports, investigator brochures, safety reports, etc.
- Coordinating and consulting with other concerned functions on the content, and assembly of regulatory documentation an ensuring consistency.
- Creating timelines and tracking deliverables to timelines to ensure that all submissions are submitted on time.
- 6/8 years of regulatory experience with basic regulatory knowledge of EU and US.
- Ideally experience in Big/Major pharma.
- IND/ Clinical Trial Applications (CTA) experience, NDA/ BLA/MAA experience is a plus.
- Can demonstrate solid oral communication and writing skills in English.
Are you interested and want to apply for this role, feel free to contact me. This position is for immediate starting, open to wait 1 calendar month. No possibility for sponsorship, due start date.