We have a current opportunity for an Associate Director, Regulatory Affairs-CMC on a 13-month contract basis. The position will be based in Chicago, IL. For further information about this position please apply. We are only able to place candidates on a W2.
Job Summary:
The Associate Director of CMC Regulatory Affairs will be responsible for creating CMC regulatory development plans and for successful execution against those plans. The Associate Director must be articulate and influence decision-making with key internal and external stakeholders while managing tight timelines.
Job Responsibilities:
- Serve as Global Chemistry, Manufacturing and Controls (CMC) regulatory leader for products at various stages of development
- Prepare Global CMC part of INDs, NDAs, MAAs, IMPDs, CTAs, annual reports, and other regulatory documents
- Develop and create CMC regulatory strategy for integrated development plans long-term planning at a cross-functional level for product, consistent with the corporate and project objectives
- Provide CMC regulatory expertise to Technical Operations and Quality teams
- Review and approve technical documentation
- Provide guidance to teams in support of clinical trial supply for local and global clinical trials
- Engage with regulatory agencies on CMC project-related matters as requested
- Identify regulatory CMC issues proactively that will impact programs and provide strategies to address them and communicate to the project team
- Provide insight and guidance on implementation of regulations with respect to the preparation and submission of CMC regulatory documentation
Requirements:
- B.S. in a scientific discipline required, BS in chemistry, pharmaceutical sciences or similar discipline preferred
- Diverse technology experience (small molecules, biologics, parenteral and oral dosage forms)
- Must have 8-10 years pharmaceutical industry experience in regulatory affairs with at least 5 years dedicated to CMC regulatory affairs matters; international experience highly preferred
- In-depth knowledge of drug development, US and global CMC guidelines and regulations
- Positive attitude, energetic and proactive
- Competencies: Functional Leadership skills, Negotiation skills, Teamwork & Collaboration, Attention to Detail, Self-Starter, Problem Solving, Organizational skills, Adaptability, Professionalism, Written and Verbal Communications, Analytical skills.
