Manager Regulatory Affairs CMC
The successful candidate will;
- support all regulatory CMC aspects of an assigned product portfolio associated with business objectives, veterinary drug development projects, regulatory change management and/or routine registration maintenance.
- 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 regulatory positions and strategies.
- Develop strong working relationships with both 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.
- Minimum of a Bachelor degree/ Master degree
- 6 years of analytical, manufacturing, and regulatory experience with biologics, biopharmaceutical or pharmaceutical products.
- 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.
- Strong technical background and excellent communications skills required with regulatory experience highly preferred.
- 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).
- Must have the ability to establish and maintain appropriate timelines
- Demonstration of an ability to handle several projects simultaneously under minimal supervision
- Good negotiating skills.
- Experience in using problem-solving 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
- 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.
- Position may require some travel less than 10%