Regulatory Affairs Specialist, Americas (Biotech)
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.
Key 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.
Key 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.
We recognize that attracting, developing and retaining the best talent is key to our strategy and success as a company. As a result, we aim for flexibility in structuring competitive compensation offers to ensure that we are able to attract the best candidates. As required by law in this state, the quoted salary range for this remote position is $76,000.00 – $122,000.00. We use broad salary ranges that reflect the competitive market for similar jobs, provide sufficient opportunity for growth as you gain experience and expand responsibilities; while also allowing for differentiation on performance based on the breadth of our ranges, most new hires will start at the company between the lower and the middle part of the applicable range. We tailor our offers within the range based on job-related factors, including organizational needs, internal equity, market data, geographic area and the selected candidate's experience, education, industry knowledge, location, technical and/or communication skills and other factors that may prove relevant during the selection process. This range is only inclusive of base salary, and base pay is just one component of Lonza's total compensation package for employees. Full-time employees are eligible to receive a performance-related bonus, as well as a comprehensive benefits package including medical and dental coverage, 401k plan, life insurance, short-term and long-term disability insurance, an employee assistance program, paid time off (PTO), and more.
Every day, Lonza's products and services have a positive impact on millions of people. For us, this is not only a great privilege, but also a great responsibility. How we achieve our business results is just as important as the achievements themselves. At Lonza, we respect and protect our people and our environment. Any success we achieve is no success at all if not achieved ethically.
People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences. In return, we offer the satisfaction that comes with improving lives all around the world. The satisfaction that comes with making a meaningful difference.
Lonza is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a qualified individual with disability, protected veteran status, or any other characteristic protected by law.
