Executive Director, CMC Global Regulatory Affairs

About the role

The Executive Director CMC (Chemistry, Manufacturing & Control) GRA (Global Regulatory Affairs) is sought to lead the global pharma CMC regulatory team and oversee the development and maintenance of pre- and post-approval regulatory strategies and submissions.

Responsibilities

• Evaluate workload, ensure timely staffing onboarding, and training.
• Monitor performance, provide feedback, and conduct routine staff meetings.
• Collaborate with manufacturing, quality, technical support, R&D, and marketing to meet submission milestones.
• Review regulatory submissions and provide input for timely pharmaceutical product approval and launch.
• Support the team members to work effectively with other functions to develop robust regulatory strategies and high-quality regulatory submissions.
• Develop and maintain standard processes and systems for regulatory compliance.
• Build and apply knowledge of current regulations for pre- and post-approval submissions.
• Communicate regulatory information and achievements within the company and to management.
• Actively lead or participate on various internal project teams, as needed.
• Perform other tasks as requested by management.

Education and Experience

• Bachelor’s degree in science, engineering, or relevant field (advanced degree preferred).
• Minimum 15 years of global regulatory and/or product development experience, including supervisory roles in the area of chemistry, manufacturing and controls (CMC).

Skills

• Strong written and oral communication skills.
• Excellent people, communication, and leadership skills.
• Highly organized with effective time management and attention to detail.

Preferred Experience and Skills

• Experience critically reviewing detailed scientific information to ensure information is presented clearly and conclusions are supported by data.
• Strong understanding of related fields (biopharmaceutical manufacturing, analytical, quality assurance, and R&D).
• Experience with regulatory requirements for mABs and sterile products.

Company Overview

Our Company's Global Animal Health division is a pioneer in the discovery, development and registration of vaccines and therapeutics for animals. Our focus is on pioneering research to deliver innovative global health solutions that advance the prevention and treatment of diseases in animals.

We are a global team of professionals working together to make a positive difference in animal care and the world’s food supply and have a deep sense of responsibility towards our customers, consumers, animals, society, and our planet.

We invest in dynamic and comprehensive R&D resources and a modern, global supply chain. We are present in more than 50 countries, while our products are available in some 150 markets.

Required Skills

• Biopharmaceuticals
• Confidentiality
• Global Health
• Manufacturing
• Mentoring Staff
• People Leadership
• Pharmaceutical Biology
• Pharmaceutical Regulatory Affairs
• Project Management
• Regulatory Affairs Compliance
• Regulatory Compliance Management
• Regulatory Reporting
• Regulatory Strategy Development
• Regulatory Training
• Strategic Thinking

Preferred Skills

• Current Employees apply HERE
• Current Contingent Workers apply HERE
• US And Puerto Rico Residents Only
• Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities.
• Please click here if you need an accommodation during the application or hiring process.
• Requirements

Requirements

• Equal Employment Opportunity Employer
• Ensures candidates can engage in a hiring process that exhibits their true capabilities.
• Ensures candidates can engage in a hiring process that exhibits their true capabilities.
• Ensures candidates can engage in a hiring process that exhibits their true capabilities.
• Ensures candidates can engage in a hiring process that exhibits their true capabilities.
• Ensures candidates can engage in a hiring process that exhibits their true capabilities.
• Ensures candidates can engage in a hiring process that exhibits their true capabilities.
• Ensures candidates can engage in a hiring process that exhibits their true capabilities.
• Ensures candidates can engage in a hiring process that exhibits their true capabilities.
• Ensures candidates can engage in a hiring process that exhibits their true capabilities.
• Ensures candidates can engage in a hiring process that exhibits their true capabilities.
• Ensures candidates can engage in a hiring process that exhibits their true capabilities.
• Ensures candidates can engage in a hiring process that exhibits their true capabilities.
• Ensures candidates can engage in a hiring process that exhibits their true capabilities.
• Ensures candidates can engage in a hiring process that exhibits their true capabilities.
• Ensures candidates can engage in a hiring process that exhibits their true capabilities.
• Ensures candidates can engage in a hiring process that exhibits their true capabilities.
• Ensures candidates can engage in a hiring process that exhibits their true capabilities.
• Ensures candidates can engage in a hiring process that exhibits their true capabilities.
• Ensures candidates can engage in a hiring process that exhibits their true capabilities.
• Ensures candidates can engage in a hiring process that exhibits their true capabilities.
• Ensures candidates can engage in a hiring process that exhibits their true capabilities.
• Ensures candidates can engage in a hiring process that exhibits their true capabilities.
• Ensures candidates can engage in a hiring process that exhibits their true capabilities.
• Ensures candidates can engage in a hiring process that exhibits their true capabilities.
• Ensures candidates can engage in a hiring process that exhibits their true capabilities.
• Ensures candidates can engage in a hiring process that exhibits their true capabilities.
• Ensures candidates can engage in a hiring process that exhibits their true capabilities.
• Ensures candidates can engage in a hiring process that exhibits their true capabilities.
• Ensures candidates can engage in a hiring process that exhibits their true capabilities.
• Ensures candidates can engage in a hiring process that exhibits their true capabilities.
• Ensures candidates can engage in a hiring process that exhibits their true capabilities.
• Ensures candidates can engage in a hiring process that exhibits their true capabilities.
• Ensures candidates can engage in a hiring process that exhibits their true capabilities.
• Ensures candidates can engage in a hiring process that exhibits their true capabilities.
• Ensures candidates can engage in a hiring process that exhibits their true capabilities.
• Ensures candidates can engage in a hiring process that exhibits their true capabilities.
• Ensures candidates can engage in a hiring process that exhibits their true capabilities.
• Ensures candidates can engage in a hiring process that exhibits their true capabilities.
• Ensures candidates can engage in a hiring process that exhibits their true capabilities.
• Ensures candidates can engage in a hiring process that exhibits their true capabilities.
• Ensures candidates can engage in a hiring process that exhibits their true capabilities.
• Ensures candidates can engage in a hiring process that exhibits their true capabilities.
• Ensures candidates can engage in a hiring process that exhibits their true capabilities.
• Ensures candidates can engage in a hiring process that exhibits their true capabilities.
• Ensures candidates can engage in a hiring process that exhibits their true capabilities.
• Ensures candidates can engage in a hiring process that exhibits their true capabilities.
• Ensures candidates can engage in a hiring process that exhibits their true capabilities.
• Ensures candidates can engage in a hiring process that exhibits their true capabilities.
• Ensures candidates can engage in a hiring process that exhibits their true capabilities.
• Ensures candidates can engage in a hiring process that exhibits their true capabilities.
• Ensures candidates can engage in a hiring process that exhibits their true capabilities.
• Ensures candidates can engage in a hiring process that exhibits their true capabilities.
• Ensures candidates can engage in a hiring process that exhibits their true capabilities.
• Ensures candidates can engage in a hiring process that exhibits their true capabilities.
• Ensures candidates can engage in a hiring process that exhibits their true capabilities.
• Ensures candidates can engage in a hiring process that exhibits their true capabilities.
• Ensures candidates can engage in a hiring process that exhibits their true capabilities.
• Ensures candidates can engage in a hiring process that exhibits their true capabilities.
• Ensures candidates can engage in a hiring process that exhibits their true capabilities.
• Ensures candidates can engage in a hiring process that exhibits their true capabilities.
• Ensures candidates can engage in a hiring process that exhibits their true capabilities.
• Ensures candidates can engage in a hiring process that exhibits their true capabilities.
• Ensures candidates can engage in a hiring process that exhibits their true capabilities.
• Ensures candidates can engage in a hiring process that exhibits their true capabilities.
• Ensures candidates can engage in a hiring process that exhibits their true capabilities.
• Ensures candidates can engage in a hiring process that exhibits their true capabilities.
• Ensures candidates can engage in a hiring process that exhibits their true capabilities.
• Ensures candidates can engage in a hiring process that exhibits their true capabilities.
• Ensures candidates can engage in a hiring process that exhibits their true capabilities.
• Ensures candidates can engage in a hiring process that exhibits their true capabilities.
• Ensures candidates can engage in a hiring process that exhibits their true capabilities.
• Ensures candidates can engage in a hiring process that exhibits their true capabilities.
• Ensures candidates can engage in a hiring process that exhibits their true capabilities.
• Ensures candidates can engage in a hiring process that exhibits their true capabilities.
• Ensures candidates can engage in a hiring process that exhibits their true capabilities.
• Ensures candidates can engage in a hiring process that exhibits their true capabilities.
• Ensures candidates can engage in a hiring process that exhibits their true capabilities.
• Ensures candidates can engage in a hiring process that exhibits their true capabilities.
• Ensures candidates can engage in a hiring process that exhibits their true capabilities.
• Ensures candidates can engage in a hiring process that exhibits their true capabilities.
• Ensures candidates can engage in a hiring process that exhibits their true capabilities.
• Ensures candidates can engage in a hiring process that exhibits their true capabilities.
• Ensures candidates can engage in a hiring process that exhibits their true capabilities.
• Ensures candidates can engage in a hiring process that exhibits their true capabilities.
• Ensures candidates can engage in a hiring process that exhibits their true capabilities.
• Ensures candidates can engage in a hiring process that exhibits their true capabilities.
• Ensures candidates can engage in a hiring process that exhibits their true capabilities.
• Ensures candidates can engage in a hiring process that exhibits their true capabilities.
• Ensures candidates can engage in a hiring process that exhibits their true capabilities.
• Ensures candidates can engage in a hiring process that exhibits their true capabilities.
• Ensures candidates can engage in a hiring process that exhibits their true capabilities.
• Ensures candidates can