Associate Director - Regulatory CMC

Company Name: Zoetis

Position Responsibilities:

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. Develop regulatory CMC filing strategies for global biopharmaceutical and 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. 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 partner groups to ensure appropriate alignment and sharing of best practices.

Other:

Previous experience with EU Animal Health Regulatory process, Global Health Authority Regulatory process, microbiological techniques, pharmaceutical manufacturing, analytical methods, aseptic processing, and biopharmaceuticals is highly desirable.

Position may require some travel less than 10%.

Education and Experience:

• Minimum of a Bachelor degree with 9 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.
• Candidates with experience in a regulatory liaison role working directly with the European Health Authority 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.
• 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.

Other Attributes 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.
• Manage and adapt to change.

Base Pay Range Information:

The following base pay range reflects the anticipated base pay for this position if a selected candidate were to be located in Colorado. Base pay may vary based on location and other factors.

Base Pay Range: $137,000 - $197,000

The following base pay range reflects the anticipated base pay for this position if a selected candidate were to be located in California, NJ Remote, NY Remote, or Washington. Base pay may vary based on location and other factors.

Base Pay Range: $155,000 - $223,000

[This position is eligible for short-term incentive compensation.] [The position is also eligible for long-term incentive.]

We offer a competitive and comprehensive benefits package, which includes healthcare, dental coverage, and retirement savings benefits along with paid holidays, vacation and disability insurance.

About Zoetis:

At Zoetis, our purpose is to nurture the world and humankind by advancing care for animals. As a Fortune 500 company and the world leader in animal health, we discover, develop, manufacture and commercialize vaccines, medicines, diagnostics and other technologies for companion animals and livestock. We know our people drive our success. Our award-winning culture, built around our Core Beliefs, focuses on our colleagues' careers, connection and support. We offer competitive healthcare and retirement savings benefits, along with an array of benefits, policies and programs to support employee well-being in every sense, from health and financial wellness to family and lifestyle resources.

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