Regulatory Affairs' CMC Consultant

Hobson Prior are currently working with a world-wide pharmaceutical organisation who are driven to help improve and prolong life. Our client is seeking a Regulatory Affairs Consultant to join them on a contract basis in Darmstadt.

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

Job Responsibilities:

• Preparation of Quality Reference Files before launch of the medicinal product (Primary project activity).
• Nitrosamine Risk Assessments for BOPPs; preparation of risk assessments, overview of submitted reports and planning of necessary testing activities.
• Evaluation, compliance check and gap analysis of a registration dossiers from external partners intended for in-licensing (Due Diligence).
• Support to answer deficiency letters from Health Authorities.
• Evaluation and reviewing of upcoming changes related to initial launches or initial proactive global harmonization of compliance status.

Requirements:

• Operational / hands on CMC Writing experience (3-4 years) for Pharma products (generics a plus).
• Technical dossier expertise (eg. analytical / qualification) either leading or reviewing / participating in compliance gap analysis and closure.
• Experience in regulatory registration processes for initial submission and maintenance activities (incl. in EU DCP/MRP, Latin America).

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.