Regulatory CMC Manager I

POSITION RESPONSIBILITIES

The successful candidate will support all Regulatory CMC aspects of an assigned product portfolio aligned with Zoetis business objectives, including veterinary drug development projects, regulatory change management, and routine registration maintenance.

Key responsibilities include:

·       Develop global Regulatory CMC strategies for pharmaceutical dosage forms.

·       Support CMC activities for new product development teams, including post-approval manufacturing changes and site transfers.

·       Prepare responses to global health authority questions and information requests.

·       Maintain awareness of emerging global biopharma/pharmaceutical CMC regulations; support the development of Zoetis regulatory positions and strategies.

·       Build strong working relationships with Zoetis manufacturing sites and contract manufacturing partners for the assigned portfolio.

·       Provide regulatory support and serve as a technical liaison on development teams to deliver high-quality CMC sections that meet global requirements for registration, approval, and launch.

·       Develop and apply knowledge of CMC regulatory science.

·       Partner with VMRD Pharmaceutical Sciences to align approaches and share best practices.

Other

·       Prior experience with EU animal health regulatory processes and/or microbiological techniques, biopharmaceutical manufacturing, analytical methods, aseptic processing, or animal health products is highly desirable.

·       This position may require travel (<10%).

 

EDUCATION AND EXPERIENCE

·       Bachelor’s degree required, with a minimum of 3 years of experience in analytical, manufacturing, and/or regulatory activities supporting biologics, biopharmaceutical, or pharmaceutical products.

·       Strong technical background and excellent written and verbal communication skills required; regulatory experience strongly preferred.

·       Author and/or review CMC regulatory assessments and contribute to the development and execution of post-approval CMC submissions and manufacturing compliance activities.

·       Demonstrated ability to work effectively in teams, including collaboration across departments and participation in cross-functional and cross-divisional (co-development) teams.

·       Participate in sub-teams to drive alignment and consensus on regulatory issues.

·       Establish and manage timelines to meet submission milestones; manage operational resources to deliver submission-ready dossiers and documents on time in accordance with global RA CMC expectations and standards.

·       Ability to manage multiple projects simultaneously with minimal supervision is a key success factor.

·       Strong negotiation skills.

Highly desirable

·       Experience in a regulatory liaison role working directly European health authorities, FDA (CVM) and/or other global health authorities on pharmaceutical, biopharmaceutical, biological registration and compliance.

·       Demonstrated problem-solving skills to propose and evaluate regulatory solutions to CMC issues, including development of contingency plans in a competitive market.

·       Strong informatics and document management capabilities in a matrix, cross-divisional environment.

·       Demonstrated integrity and sound judgment; ability to assess business and scientific ethics in regulatory decisions and strategic plans.

 

OTHER ATTRIBUTES (PREFERRED)

·       Experience in genetic engineering, bioprocessing, protein analysis, microbiology, and product development activities supporting preparation and submission of Regulatory CMC dossiers to meet global business objectives and health authority requirements.

·       Working knowledge of GMP requirements for sterile and non-sterile manufacturing.

·       Familiarity with global standards and expectations for analytical testing.

·       Self-directed and able to work with minimal supervision.

·       Strong organizational, prioritization, and time-management skills; able to perform effectively under pressure.

·       Excellent written and verbal communication skills.

·       Experience supporting an animal health portfolio.

Demonstrated ability to manage and adapt to change.

 

 

Full time

 

 

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