About the Company
Lonza is a global partner to the pharmaceutical, biotech and nutrition industries. We help our customers to enable new medicines and products that improve the lives of people globally. Lonza combines scientific insight and technological innovation to enable our customers to deliver their breakthroughs in the healthcare and life sciences sectors. Headquartered in Basel, Switzerland, Lonza is a leading global supplier of active pharmaceutical ingredients, biopharmaceuticals, and specialty ingredients.
Job Description
We are seeking an experienced Senior Regulatory Affairs Chemist with a strong focus on global compliance to join our dynamic team in West Valley City, UT. In this pivotal role, you will be responsible for ensuring that Lonza’s diverse product portfolio, including chemicals, APIs, and excipients, meets all international regulatory requirements. You will serve as a subject matter expert, providing strategic guidance on chemical regulations, registration dossiers, and post-market surveillance. This position requires a deep understanding of global chemical regulatory frameworks such as REACH, GHS, TSCA, K-REACH, and others, as well as an ability to navigate complex scientific data to support compliance initiatives.
Key Responsibilities
- Lead the preparation, submission, and maintenance of regulatory dossiers and registrations for chemical products globally (e.g., REACH, TSCA, K-REACH).
- Interpret and apply complex global chemical regulations and guidelines to Lonza's products and operations.
- Act as a primary contact point for regulatory agencies and internal stakeholders on chemical compliance matters.
- Provide expert regulatory guidance during new product development and product lifecycle management.
- Conduct regulatory impact assessments for product changes, new market entries, and evolving regulations.
- Develop and implement robust regulatory strategies to ensure timely market access and continued compliance.
- Participate in cross-functional teams to ensure regulatory requirements are integrated into product design, manufacturing, and quality processes.
- Manage and maintain safety data sheets (SDS) and labels in compliance with GHS and local regulations.
- Monitor global regulatory developments and communicate potential impacts to relevant business units.
- Train and mentor junior regulatory affairs staff on chemical compliance topics.
Required Skills
- Bachelor's degree in Chemistry, Chemical Engineering, Regulatory Affairs, or a related scientific field.
- 5+ years of experience in regulatory affairs within the chemical, pharmaceutical, or related industries.
- In-depth knowledge of major global chemical regulations (e.g., REACH, TSCA, K-REACH, GHS, CLP).
- Proven experience in preparing and submitting regulatory dossiers and registrations.
- Strong analytical and problem-solving skills with meticulous attention to detail.
- Excellent written and verbal communication skills for technical and regulatory discussions.
- Ability to work independently and collaboratively in a fast-paced global environment.
- Proficiency in regulatory information management systems.
Preferred Qualifications
- Master's or Ph.D. in Chemistry, Chemical Engineering, or Regulatory Affairs.
- Experience with biocide or agrochemical regulations.
- Certification in Regulatory Affairs (e.g., RAC).
- Experience with product stewardship and hazard communication.
- Project management experience in a regulatory context.
- Familiarity with ISO 9001 and cGMP environments.
Perks & Benefits
- Competitive salary and performance-based bonuses.
- Comprehensive health, dental, and vision insurance.
- 401(k) retirement plan with company match.
- Paid time off and company holidays.
- Life and disability insurance.
- Employee assistance program.
- Professional development and continuing education opportunities.
- On-site fitness center and wellness programs.
- Tuition reimbursement.
How to Apply
If you are interested in this position, please click the "Apply Now" button below. To ensure your application is properly considered, please prepare the following:
- An up-to-date Resume or CV
- A brief cover letter summarizing your experience and motivation
Applications are reviewed on a rolling basis. Only shortlisted candidates will be contacted for an interview.
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