Hobson Prior are looking for a Regulatory CMC Manager to join a leading pharmaceutical organisation who are focused on developing and offering therapy options for patients with rare diseases. you will play a key role in bridging CMC-related development and RA submission activities from pharmaceutical development to life cycle.

Job Responsibilities:

• Work and co-operate with our CMC Leads in a dynamic team.
• You are strongly able to align CMC strategies for our products with the RA department.
• Ensure effective communication between CMC Leads and RA-department as well as Quality Management.

Key Skills:

• Strong communication and presentation skills in English and German.
• IT skills (MS Office, Adobe Acrobat, alternatively MS-Project).

Requirements:

• Natural science/scientific background (HTL, FH, university) and several years of professional experience in below fields.
• Profound knowledge of GMP and CMC regulations/guidelines.
• Experience in writing / reviewing IMPDs and CTDs (Module 3).
• Knowledge of RA procedures and submissions.
• Practical experience in CMC development of small molecules, oral solid dosage forms or parenteral products (injectables, lyo) - synthesis, formulation, manufacturing, analytics.

Apply now:

If you are interested in learning more or applying to this exciting opportunity, please complete the form below and attach a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist, please request a call back 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.