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Global Regulatory Affairs Lead (Oncology)

SIRE Life Sciences®

Amsterdam, zagranica

SIRE Life Sciences®

Global Regulatory Affairs Lead (Oncology)

Location: Amsterdam
Global Regulatory Affairs Lead (Oncology)


The company
Our client is one of the largest biopharmaceutical clients in the world. Every day, they are working towards their main goal: to find and develop innovative medical solutions to prevent, treat and cure diseases and disorders.

Please note that this is a remote, part-time job opportunity (24-32 hours/week).


Role description
Within this role, you will be responsible to lead the Global Regulatory Team and to develop and maintain the Global Regulatory Strategy and Plan for oncology.

Responsibilities
Co-lead and/or lead the Global Regulatory Team for assigned asset(s) in our client’s oncology portfolio.
Collaboratively develop and maintain the Global Regulatory Strategy and Plan.
Act as a liaison to internal/external business partners.
Support multi-disciplinary matrixed project teams adhering to regulatory requirements for programs and products.
Review the workflow for complex regulatory documents for regulatory submissions to assure that they are complete, organized, of high quality, and compliant with applicable health agency regulations.
Prepare, contribute to and/or archive routine regulatory submissions (e.g., responses to health authority questions, DSUR, PBRER).

Requirements
Relevant education, combined with 4+ years of experience working in the pharma/biotech industry, 3+ from that in regulatory affairs.
Experience with leading or supporting the preparation of (s)BLA/(s)NDA/MAA, INDs/CTAs, or Health Authority meeting briefing documents and negotiating with a national/regional health authority.
Proven understanding of the clinical development of drugs and/or novel biologics products.
Ability to work in electronic document management systems, e.g., Veeva vault.
A professional level of written and spoken English.
Excellent stakeholder management skills.  

Other information
Are you interested in this or another role? Please do not hesitate to contact me by applying to this position.
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SIRE Life Sciences®

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