Hobson Prior are looking for a Senior Manager Regulatory Affairs to join a brilliant pharmaceutical establishment on a permanent basis located in Amsterdam. Our client is focused on providing the best remedies to protect both the health and wellbeing of others.

Please note that to be considered for this role you must have the right to work in this location.

Key Responsibilities:

• For this role, you will guide the interactions with health authorities to approve CMC methods and data needs to enable successful agreement on allocated products/projects.
• Offer training and leadership to less experienced members of the EU CMC regulatory team.
• Forecast both when and how regulatory concerns may affect the business and conscientiously and quickly advise project teams and management accordingly.
• To assist in the production of internal international and local SOPs and guidance papers, you will partake in the CMC process initiatives.
• Any other assigned duties.

Requirements:

• Must be an EU citizen or currently reside in Amsterdam.
• Acquaintance with small molecule dosage forms, ideally sterile and oral tablet projects, as well as with biological products which would be beneficial.
• Familiarity with assisting in early and late phase clinical development projects with prior involvement in IMPD planning for clinical trial applications.
• Know-how of eCTD needs and familiarity with planning of CMC documentation for new product EU MAAs such as Module 3, Module 2 QOS, Module 1 Quality associated administrative documents.
• Past involvement in assisting post-approval variations for CMC changes.
• Know-how of EMA and ICH regulatory CMC/Quality regulations applicable across the product lifecycle.
• Former involvement with age-suitable paediatric formulation regulations and needs, as well as assist in planning CMC sectors for PIPs.

Apply now:

If you are interested in learning more or applying to this exciting opportunity then please click "Apply" and upload a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist directly, please select "Contact me" at the top of this page.

Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.