Associate Director/Director, CMC - FDA Experience (Central/Eastern Europe)

Associate Director/Director, CMC - FDA Experience (Central/Eastern Europe)

Allucent

Remote, Europe

Description

We are looking for an Associate Director/Director, Chemistry Manufacturing and Controls (CMC) to join our A-team (hybrid*/remote). As a Associate Director/Director, CMC at Allucent, you are responsible for assisting clients with Chemistry Manufacturing and Control (CMC) and related pharmaceutical development activities of drug, biologic or medical device products. Responsibilities may include analysis/review of drug substance synthesis, pre-formulation and formulation evaluation, analysis of manufacture, scale-up and process validation, providing support of analytical methods development and validation, and evaluation of packaging and labeling components. The CMC Associate Director/Director leads and/or participates in Health Authority (HA) communications including correspondences, teleconferences, and meetings. The CMC Associate Director/Director reviews, provides advice on, or authors CMC-related regulatory content for HA submissions, reports, protocols, and other scientific documents.  

In this role your key tasks will include:

• Reviews and/or writes regulatory/scientific documents or sections thereof, with efficiency, accuracy, and independent thought
• Contributes significantly to strategic/CMC discussions and associated documents/reports regarding drug, biologic, or device development
• Guides the writing of regulatory/scientific documents written by other project team members
• Has advanced scientific knowledge of HA Regulatory Guidance and Regulations
• Interacts with various HAs, including leading HA meetings and participating as a subject matter expert; assists in preparation of meeting and briefing documents, and preparing responses to inquiries 
• Contributes significantly to strategic/CMC discussions and associated documents/reports regarding drug, biologic, or device development issues with primary emphasis on scientific aspects
• Has advanced understanding of electronic common technical document (eCTD) format and requirements of regulatory submissions 
• Prepares product development plans and/or strategies from early development through Phase 4 
• Provides strategic advice in evaluating impact and necessary filing requirements and strategies for drug product post-approval changes/variations   
• Actively supports staff learning & development within the company 
• Provides guidance and advises Project Leads, and/or Project Teams 
• Adherence to project budgets and contracts including scope and scope changes, timeline deliverables and active management of resources 
• Manages projects as a Consulting Technical Lead as assigned  
• Leads and/or participates in meetings with clients 
• Provides mentorship to team members 
• Acts professionally with peers and clients, knows business etiquette 

Requirements

To be successful, you will possess:

• Requires a B.S., R.Ph., M.S., Ph.D., or equivalent degree, in a scientific area, and equivalent combination of relevant experience in drug, biologic, or device development 
• Scientific and regulatory knowledge of drug, biologic, or device development 
• Critical thinking and analytical skills, as well as strong written and verbal communication skills in English 
• Strong computer skills, including SharePoint, Word, Excel, and PowerPoint 
• Quality focus 
• Emotional intelligence and decision-making skills 
• Innovative, creative, and practical thinking including problem-solving skills 
• ≥ 10 years’ post-degree of directly relevant experience in drug, biologic, or device development desirable

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