Executive Director, CMC Global Regulatory Affairs

Job Description Join the Rahway, New Jersey Animal Health Team-

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. An experienced and dynamic 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.

• 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. This may involve leading complex projects related to these processes or systems.
• Build and apply knowledge of current regulations for pre- and post-approval submissions.
• Act as the primary liaison with regulatory authorities, including FDA CVM and US Agent.
• 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.

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

• 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).
• Strong written and verbal communication skills in multicultural settings and ability to communicate in a succinct, logical manner.
• Experience with regulatory requirements for mABs and sterile products.

Our Animal Health Division is a trusted global leader in veterinary medicine, dedicated to preserving and improving health, well-being, and performance of animals and the people who care for them. 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.

-Through our commitment to The Science of Healthier Animals®, we offer veterinarians, farmers, pet owners and governments one of the widest ranges of veterinary pharmaceuticals, vaccines and health management solutions and services. 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.

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

Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities.

As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics.

--As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities.

- For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:

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