Executive Director, CMC Global Regulatory Affairs

MSD • Rahway, NJ

2d • $231,900 - $365,000 • Hybrid

About The Position

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.

Requirements

• 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.
• Bachelor’s degree in science, engineering, or relevant field

Nice To Haves

• 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.
• Advanced degree preferred.

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. 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.

Benefits

• medical, dental, vision healthcare and other insurance benefits (for employee and family)
• retirement benefits, including 401(k)
• paid holidays
• vacation
• compassionate and sick days

What This Job Offers

• Job Type: Full-time
• Career Level: Executive