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Job Details

CMC Regulatory Manager - Germany

Company: Barrington James Clinical
Reference: CRBG - CMC
Closing Date: 23 Feb 18
Type: Full Time
Salary (£): On Application

Job Summary:

Call Carlos Biggemann on +44(0)1293 776644 or email me for more details


Your responsibilities

Responsibility for late-stage CMC development projects with a focus on process validation and market preparation

Plan and track CMC (Chemistry, Manufacturing and Controls) activities regarding timelines, resources and costs

Support external production during CMC process development, scaling-up, stability batch manufacturing, compatibility testing and process validation

Preparation and periodic adaption of CMC project plans based on feedback of relevant project team members

Provide input for periodic updates on project status, including budget analysis

Clinical trial supply management for (pre-)clinical studies

CMC contact for internal teams (R&D, Pre-clinical and Clinical Development, Regulatory Affairs, QM) and external vendors, CMOs and laboratories

Your qualification

University degree in Pharmacy, Chemistry, Biology or similar Life Sciences

At least 3+ years of professional experience in project management within the pharmaceutical industry

Knowledge of pharmaceutical product development processes and regulatory procedures (EU/USA), especially in the area of CMC development of biologics

Excellent project leadership skills and the ability to drive and coordinate topics with multiple stakeholders

Skilled in the use of risk and project management tools, e.g. MS Project, and the ability to identify and resolve key technical CMC issues during project development

Familiarity with MS Office (Excel, PowerPoint, Word)

Excellent conflict management capabilities

Strong communication and presentation skills

Fluent in English and German, both written and spoken

Apply for this job: CMC Regulatory Manager - Germany

Contact Information:

Address:  Head Office
Victoria House Consort Way Horley Surrey
Tel:  01293 776644
Fax:  01293 822333
Website:  Visit Our Web Site

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