Regulatory Affairs Specialist, Americas

Lonza • Morristown, NJ

247d • $76,000 - $122,000 • Remote

About The Position

Today, Lonza is a global leader in life sciences operating across five continents. While we work in science, there's no magic formula to how we do it. Our greatest scientific solution involves hard-working individuals collaborating, generating ideas that support businesses in serving people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. And that's the kind of work we want to be part of. As a Regulatory Affairs Specialist, you will play a pivotal role in monitoring regulatory developments, ensuring compliance, and driving regulatory excellence across multiple product categories, including excipients, pharmaceuticals, food, and feed. This fully remote position is perfect for a proactive professional with strong regulatory knowledge and a collaborative approach. You will serve as a key liaison between internal teams, customers, and regulatory authorities, supporting innovation, quality, and market access through strategic compliance efforts.

Requirements

• Bachelor's degree or equivalent experience in Life Sciences, Regulatory Affairs, or a related field (advanced degree is a plus).
• Proven track record in regulatory affairs, preferably in the pharmaceutical, excipient, food, or related manufacturing sectors.
• Strong knowledge of GMP standards and regulatory frameworks (FDA, USDA, Health Canada, TGA, etc.).
• Experience with regulatory documentation, impact assessments, and customer/authority interactions.
• Demonstrated ability to translate regulatory requirements into actionable plans.
• Excellent communication skills and the ability to collaborate across cross-functional teams.
• Diligent with strong organizational and documentation skills.
• Ability to work independently in a remote environment and prioritize tasks effectively.
• Proficiency in Microsoft Office Suite and regulatory databases/tools.

Responsibilities

• Supervise and assess regulatory developments across excipient, pharmaceutical, food, and feed industries, including GMP requirements, and maintain a centralized impact database.
• Translate new regulations and industry guidelines into actionable implementation plans and ensure compliance across relevant teams.
• Evaluate change requests within the Americas region for regulatory impact and handle resulting action items effectively.
• Serve as the coordinator for the Regulatory Information Bulletin process and maintain required documentation to meet quality and regulatory standards.
• Respond to customer and authority inquiries with timely, professional, and compliant solutions to support happiness and regulatory alignment.
• Support cross-functional teams (marketing, R D, sales) with regulatory input for growth and innovation initiatives, including business impact assessments.
• Collaborate with regulatory and certification bodies to maintain vital product and site approvals (FDA, USDA, Health Canada, TGA, etc.).
• Assist with regulatory submissions, including DMF applications, amendments, annual reports, and proprietary ingredient registrations.

Benefits

• Medical and dental coverage
• 401k plan
• Life insurance
• Short-term and long-term disability insurance
• Employee assistance program
• Paid time off (PTO)
• Performance-related bonus

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Industry: Professional, Scientific, and Technical Services
• Education Level: Bachelor's degree