Head of Regulatory Affairs

My client is a listed clinical phase biotechnology looking for a strong & established Head of Regulatory to join their growing organisation.

As a Head of Regulatory you will have the following responsibilities:

• Provide leadership and hands on management of Regulatory Affairs their clinical and preclinical development portfolio, including CMC.
• You will work as the interface between my client and the regulatory authorities, through the entire life cycle of the medication, from early development to commercialisation
• You’ll serve as the contact for the regulatory authorities and manages the documentation required for all steps of development and commercialisation

Interested? For this position you’ll need the following education, experience and skills:

• BSc or higher academic degree, including MD and PharmD
• You have at least 8+ years’ experience in regulatory affairs, supporting clinical development programs of NCEs and/or biologics
• NDAs, INDs, CTA,NTA, PRIME ODD, MAA, regulatory advice meetings and other relevant regulatory submissions
• You have strong project and people management skills

Please apply by filling in your details below or reach out directly to me via email on to discuss further.