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  • Location

    Netherlands

  • Job title:

    Global Regulatory Team Lead

  • Sector:

    Pharmaceutical

  • Job ref:

    50135

  • Start Date:

    2023-02-13

Global Regulatory Team Lead

The company
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.

Role Description
As a Global Regulatory Team Lead you will be responsible for provide Global Regulatory Strategy.

 Responsibilities 
- 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.

Requirements

- +/- 3 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.

Other Information 
Are you interested and want to apply for this role, feel free to contact me.