This job is archived
(Archived) Manager/ Assoc Director Regulatory Affairs CMC
Job Description
POSITION RESPONSIBILITIES:
The successful candidate will provide leadership to a small team of regulatory associates and support for the regulatory strategy, preparation, submission and compliance of regulatory CMC Quality sections of pharmaceutical dossiers associated with new product registrations in the Global Regulatory Affairs CMC team. The position will be responsible for all aspects of marketed product regulatory compliance including change management, dossier maintenance (MA renewals), new market introductions and API and drug product manufacturing site transfers.
The scope of work includes:
- Providing leadership and management oversight for a geographically diverse team of RA-CMC colleagues supporting the US and Canada, Latin America and Asia Pacific region.
- Working with the Global RA-CMC leadership team to develop harmonized work processes and strategic direction for the RA-CMC organization.
- Negotiating with regulatory agencies on CMC issues, including registration requirements, representing Zoetis and the business objectives for assigned projects.
- Coordinating the compilation of documentation for CMC regulatory submissions in support of global marketing applications.
- Providing regulatory support and serve as a technical liaision on Development teams in their efforts to deliver a quaility CMC technical section that will meet global requirements for registration, approval and launch of a new product.
- Developing a global knowledge of CMC regulatory science. The incumbent will be expected to maintain knowledge and awareness of emerging global CMC regulations and assist in the development of Zoetis positions and strategies.
- The position will work closely with multiple business lines including Manufacturing, Quality, and Marketing to fulfill Zoetis business objectives within agreed upon timelines.
- The position 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.
- The position will be responsible for preparation of responses to Global Health Authority queries including US FDA
Position may require some travel less than 10%
EDUCATION AND EXPERIENCE:
Minimum of a bachelor’s degree/ Master degree with ten years of analytical, manufacturing, and regulatory experience with biopharmaceutical or pharmaceutical products. Strong technical background and excellent communications skills required with management experience highly preferred. 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
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.
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:
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- Previous experience with pharmaceutical or biopharmaceutical development, API/ABI and drug product manufacturing, Vaccines, microbiological techniques, analytical methods, aseptic processing, and Animal Health products is highly desirable.
- 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