Regulatory CMC Senior Associate II

Zoetis • Kalamazoo, MI

23h

About The Position

The successful candidate will support all regulatory CMC aspects of an assigned product portfolio associated with Zoetis business objectives, veterinary drug development projects, regulatory change management and/or routine registration maintenance. Responsibilities will include, but not limited to: 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 Zoetis regulatory positions and strategies. Develop strong working relationships with both Zoetis manufacturing sites and contract manufacturing interfaces for assigned portfolio. Provide regulatory support and serve as a technical liaison on Development teams in their efforts to deliver a quality CMC technical section that will meet global requirements for registration, approval and launch of a new product. Develop a knowledge of CMC regulatory science. Work with VMRD Pharmaceutical Sciences to ensure appropriate alignment and sharing of best practices. Other: Previous experience with microbiological techniques, biopharmaceutical manufacturing, analytical methods, aseptic processing, and Animal Health products is highly desirable. Position may require some travel less than 10%.

Requirements

• Minimum of a Bachelor degree with 7 years of analytical, manufacturing, and regulatory experience with biologics, biopharmaceutical or pharmaceutical products.
• Strong technical background and excellent communications skills required with regulatory experience highly preferred.
• Candidate will review/author regulatory assessments for CMC activities and contribute to development and execution of submissions for post approval CMC manufacturing compliance.
• 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).
• The candidate will also participate on sub-teams to achieve consensus for regulatory issues.
• Must have the ability to establish and maintain appropriate timelines to meet submission milestones and manage operational resources for specific projects/products to ensure delivery of submission-ready dossiers and documents on time in accordance with global RA CMC expectations/standards.
• Demonstration of an ability to handle several projects simultaneously under minimal supervision will be a key attribute of the successful candidate.
• Good negotiating skills.
• 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.
• 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.

Nice To Haves

• Previous experience with microbiological techniques, biopharmaceutical manufacturing, analytical methods, aseptic processing, and Animal Health products is highly desirable.
• 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 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.
• Understanding of GMPs for sterile and non-sterile manufacturing
• Understanding of global standards for analytical testing
• Very self-directed - can work with little supervision on most tasks
• Excellent organization, prioritization, and time management skills – can work effectively under pressure
• Excellent written and oral communication skills
• Experience with an animal health portfolio

Responsibilities

• 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 Zoetis regulatory positions and strategies.
• Develop strong working relationships with both Zoetis manufacturing sites and contract manufacturing interfaces for assigned portfolio.
• Provide regulatory support and serve as a technical liaison on Development teams in their efforts to deliver a quality CMC technical section that will meet global requirements for registration, approval and launch of a new product.
• Develop a knowledge of CMC regulatory science.
• Work with VMRD Pharmaceutical Sciences to ensure appropriate alignment and sharing of best practices.

What This Job Offers

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