Senior Specialist Regulatory Affairs CMC (m/w/d)

MSD

6d • Hybrid

About The Position

We are looking for a Senior Specialist Regulatory Affairs CMC (m/w/d) to join our team in the innovative research location in Schwabenheim (near Mainz). Scope of the position is supporting the studies and documentation for the CMC part of the dossier needed to gain new registrations of Animal Health pharmaceutical products throughout the world. This position is a full-time and temporary contract for 12 months.

Requirements

• Minimum B.S. in pharmacy, chemistry, or science degree
• Experience in preparing CMC sections in the Common Technical Document format
• Experience in preparing US supplements, and EU variations
• Experience critically reviewing detailed scientific information
• Good understanding of related fields (manufacturing, analytical, quality assurance, and R&D)
• Strong written and verbal communication skills in multicultural settings
• High level of professionalism
• Proficient in English

Responsibilities

• Collaborate cross-functionally with manufacturing, quality, technical support, R&D, in close coordination with the main project responsible CMC AD
• Work with the project team, CORAs and the CMC AD to ensure all important CMC
• Support the development and maintenance of standard processes and systems to maintain regulatory information to support regulatory compliance. This may involve participating in complex projects related to these processes or systems
• Maintain and foster current in depth knowledge and experience applying the EMA, FDA, VICH, and other country specific CMC/Quality related guidelines to pre- and post-approval CMC submissions
• Providing documentation to countries including creating and maintaining the corresponding documents and binders in Alexx submissions
• Supporting “senior” team member (CMC AD) during LOQ-A phase by e.g., tracking
• Supporting the CMC project team member in various project activities such as Gap & Risk assessment, kick-off meetings (CORAs)
• Checking submitted or registered status with CORAs and compiling variations needed for countries before launch in case relevant changes happened during registration in US or EU to ensure compliance
• Participate on new product development teams as well as other types of teams

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees