Modis has a Regulatory CMC Senior Associate opportunity available in Kalamazoo, MI. You will support all regulatory CMC (Chemistry, Manufacturing and Controls) aspects of an assigned product portfolio associated with Company business objectives, veterinary drug development projects, regulatory change management and/or routine registration maintenance. You will also participate on sub-teams to achieve consensus for regulatory issues. This is a direct hire opportunity.
Regulatory CMC Senior Associate responsibilities include:
• Develop regulatory CMC filing strategies for global pharmaceutical dosage forms.
• Support CMC activities for new product development teams and post-approval manufacturing changes or site transfers.
• Prepare responses to global Health Authority queries including FDA/CVM.
• Maintain knowledge and awareness of emerging global biopharma and pharmaceutical CMC regulations and assist in the development of Company regulatory positions and strategies.
• Develop strong working relationships with both Company manufacturing sites and contract manufacturing interfaces for assigned portfolio.
• Develop a knowledge of CMC regulatory science.
• Work with VMRD Pharmaceutical Sciences to ensure appropriate alignment and sharing of best practices.
• Review/author regulatory assessments for CMC activities and contribute to development and execution of submissions for post approval CMC manufacturing compliance.
• Minimum of a Bachelor degree/ Master degree with six years of analytical, manufacturing, and regulatory experience with biologics, biopharmaceutical or pharmaceutical products. Experience with an animal health portfolio and understanding of GMPs for sterile and non-sterile manufacturing preferred.
• Strong technical background and excellent communications skills required. Excellent written and oral communication skills
• Must have the ability to work within teams, including collaborating with colleagues, maintaining partnerships with other departments, serving on cross-functional teams, as well as cross divisional teams (Co-development).
• Demonstration of an ability to handle several projects simultaneously under minimal supervision will be a key attribute of the successful candidate. Excellent organization, prioritization, and time management skills – can work effectively under pressure
• Candidates with experience in a regulatory liaison role working directly with FDA (CVM) or other global Health Authorities in the area of biological, biopharmaceutical or pharmaceutical registration and compliance is highly desirable.
• Experience in using problem-solving skills to propose and evaluate regulatory solutions to CMC issues and manage the preparation of contingency plans to meet the objectives of the Business in a highly competitive market. Good negotiating skills.
• Must be able to apply high level informatics and document management skills within a matrix, cross divisional environment.
• Must demonstrate integrity in all areas of the work environment; assess business and scientific ethics for all regulatory decisions and strategic plans.
• Previous experience with microbiological techniques, biopharmaceutical manufacturing, analytical methods, aseptic processing, and Animal Health products is highly desirable. Experience in genetic engineering, bioprocessing, protein analysis, microbiology, and development activities for products in support of the preparation and submission of regulatory CMC dossiers to meet global business objectives and Health Authority requirements preferred.
• Position may require some travel less than 10%
If you are interested in this Regulatory CMC Senior Associate opportunity in Kalamazoo, MI. then please click APPLY NOW.
Equal Opportunity Employer/Veterans/Disabled
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The Company will consider qualified applicants with arrest and conviction records.