Senior Associate II / Manager I Regulatory Affairs CMC at Zoetis, Inc.
Posted in Compliance 30+ days ago.
This job brought to you by America's Job Exchange
Type: Full Time
Location: Kalamazoo, Michigan
The successful candidate will support all regulatory CMC (Chemistry Manufacturing Control) aspects of an assigned product portfolio associated with Zoetis Business Unit objectives, GMS (Global Manufacturing Support) strategies, pharmaceutical change management and/or routine registration maintenance. Develop regulatory CMC filing strategies for pharmaceutical dosage forms for global markets. Support regulatory activities for post-approval manufacturing changes or site transfers. Prepare responses to global Health Authorities queries. Maintain knowledge and awareness of emerging global CMC regulations and assist in the development of Zoetis regulatory positions and strategies. Develop strong working relationships and act as primary interface with both Zoetis manufacturing sites and contract manufacturing interfaces for assigned portfolio.
Support the regulatory strategy, preparation and submission of regulatory CMC sections in dossiers associated with all Annimal Health dosage forms, and product line extension registrations for assigned projects. Provide regulatory support and serve as a technical liaision on Development teams in their efforts to deliver a quaility CMC dossier for assigned projects that will meet global requirements for registration, approval and launch of a new product. Coordinate the compilation of documentation for CMC regulatory submissions in support of global marketing applications. Develop a knowledge of CMC regulatory science. Work with VMRD Pharmaceutical Sciences to ensure appropriate alignment and sharing of best practices.
Previous experience in pharmaceutical manufacturing, product development, Quality Assurance, or Regulatory Affairs highly desirable
Position may require some travel up to 10%
EDUCATION AND EXPERIENCE:
Bachelor Degree with a minimum of three years of technical/scientific/pharmaceutical and/or regulatory experience with global pharmaceutical registrations. Strong technical background and excellent communications skills required with regulatory experience highly preferred. Requires experience in functional pharmaceutical development activities for specific projects or products in support of the preparation and submission of regulatory CMC dossiers to meet global business objectives and Health Authority requirements. 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. Manage operational resources and global RA CMC expectations/standards for specific projects/products and ensure delivery of submission-ready dossiers and documents on time. 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 FDA (CVM) or other global Health Authorities in the area of pharmaceutical registration and/or 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:
* Understanding of pharmaceutical manufacturing processes, including GMPs
* Very self-directed - can work with little supervision on most tasks
* Excellent organization, prioritization, and time management skills can work effectively under pressure
* Working experience with one or more of the following applications and technologies: change control, document control system, Quality systems
* Experience with an animal health portfolio
* Manage and adapt to change
Zoetis is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status or any other protected classification. Disabled individuals are given an equal opportunity to use our online application system. We offer reasonable accommodations as an alternative if requested by an individual with a disability. Please contact Zoetis Colleague Services at firstname.lastname@example.org to request an accommodation. Zoetis also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must possess or obtain authorization to work in the US for Zoetis. Zoetis retains sole and exclusive discretion to pursue sponsorship for the acquisition or maintenance of nonimmigrant status and employment eligibility, considering factors such as availability of qualified US workers. Individuals requiring sponsorship must disclose this fact.