Regulatory CMC Senior Associate II
Zoetis
6 hours ago
Remote friendly (Kalamazoo, MI)
United States
Corporate Functions
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.
Responsibilities (including 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; assist in developing regulatory positions and strategies.
- Develop strong working relationships with Zoetis manufacturing sites and contract manufacturing interfaces for the assigned portfolio.
- Provide regulatory support and serve as a technical liaison on Development teams to deliver quality CMC technical sections meeting global requirements for registration, approval, and launch.
- Develop knowledge of CMC regulatory science.
- Work with VMRD Pharmaceutical Sciences to align and share best practices.
Other:
- Previous experience with microbiological techniques, biopharmaceutical manufacturing, analytical methods, aseptic processing, and Animal Health products is highly desirable.
- Travel may be required (<10%).
EDUCATION AND EXPERIENCE / QUALIFICATIONS:
- Minimum Bachelor’s degree with 7 years of analytical, manufacturing, and regulatory experience with biologics, biopharmaceutical, or pharmaceutical products.
- Strong technical background and excellent communications skills; regulatory experience highly preferred (review/author CMC regulatory assessments; contribute to post-approval CMC manufacturing compliance submissions).
- Ability to work in teams and on cross-functional/cross-divisional teams; participate on sub-teams to achieve regulatory consensus.
- Ability to establish/maintain timelines to meet submission milestones and manage resources to deliver submission-ready dossiers on time per global RA CMC expectations/standards.
- Ability to handle several projects simultaneously with minimal supervision.
- Good negotiating skills.
- Regulatory liaison experience working directly with FDA (CVM) or other global Health Authorities is highly desirable.
- Problem-solving skills to propose/evaluate regulatory solutions to CMC issues; manage contingency plans.
- High-level informatics and document management skills in a matrix, cross-divisional environment.
- Demonstrate integrity; assess business and scientific ethics for regulatory decisions and strategic plans.
Other Attributes Desirable:
- Experience in genetic engineering, bioprocessing, protein analysis, microbiology, and development for regulatory CMC dossiers.
- Understanding of GMPs for sterile and non-sterile manufacturing.
- Understanding of global standards for analytical testing.
- Very self-directed; excellent organization, prioritization, and time management; works well under pressure.
- Excellent written and oral communication skills.
- Experience with an animal health portfolio.
- Ability to manage and adapt to change.
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 (including 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; assist in developing regulatory positions and strategies.
- Develop strong working relationships with Zoetis manufacturing sites and contract manufacturing interfaces for the assigned portfolio.
- Provide regulatory support and serve as a technical liaison on Development teams to deliver quality CMC technical sections meeting global requirements for registration, approval, and launch.
- Develop knowledge of CMC regulatory science.
- Work with VMRD Pharmaceutical Sciences to align and share best practices.
Other:
- Previous experience with microbiological techniques, biopharmaceutical manufacturing, analytical methods, aseptic processing, and Animal Health products is highly desirable.
- Travel may be required (<10%).
EDUCATION AND EXPERIENCE / QUALIFICATIONS:
- Minimum Bachelor’s degree with 7 years of analytical, manufacturing, and regulatory experience with biologics, biopharmaceutical, or pharmaceutical products.
- Strong technical background and excellent communications skills; regulatory experience highly preferred (review/author CMC regulatory assessments; contribute to post-approval CMC manufacturing compliance submissions).
- Ability to work in teams and on cross-functional/cross-divisional teams; participate on sub-teams to achieve regulatory consensus.
- Ability to establish/maintain timelines to meet submission milestones and manage resources to deliver submission-ready dossiers on time per global RA CMC expectations/standards.
- Ability to handle several projects simultaneously with minimal supervision.
- Good negotiating skills.
- Regulatory liaison experience working directly with FDA (CVM) or other global Health Authorities is highly desirable.
- Problem-solving skills to propose/evaluate regulatory solutions to CMC issues; manage contingency plans.
- High-level informatics and document management skills in a matrix, cross-divisional environment.
- Demonstrate integrity; assess business and scientific ethics for regulatory decisions and strategic plans.
Other Attributes Desirable:
- Experience in genetic engineering, bioprocessing, protein analysis, microbiology, and development for regulatory CMC dossiers.
- Understanding of GMPs for sterile and non-sterile manufacturing.
- Understanding of global standards for analytical testing.
- Very self-directed; excellent organization, prioritization, and time management; works well under pressure.
- Excellent written and oral communication skills.
- Experience with an animal health portfolio.
- Ability to manage and adapt to change.