About the Company
Lonza is a global partner to the pharmaceutical, biotech and nutrition industries. We help our customers to enable a healthier world by providing products and services that allow them to deliver innovative medicines and therapies. With a strong presence across five continents, our integrated solutions span the entire product life cycle, from early-stage research to patient delivery. Join us in shaping the future of health!
Job Description
We are seeking a highly skilled and experienced Senior Regulatory Affairs Chemist to join our dynamic team in Pasco, WA. This critical role focuses on ensuring global compliance for our diverse portfolio of chemical products and raw materials. You will be responsible for interpreting complex international regulations, developing robust regulatory strategies, and managing submissions to support new product development and market access. This position requires a deep understanding of chemical regulations, excellent analytical skills, and a proactive approach to regulatory challenges.
Key Responsibilities
- Lead and manage regulatory projects related to global chemical compliance, including REACH, GHS, TSCA, K-REACH, and other regional regulations.
- Prepare, review, and submit regulatory dossiers, notifications, and registrations for chemical substances and mixtures across various jurisdictions.
- Conduct thorough regulatory assessments for new and existing products, identifying potential compliance risks and recommending mitigation strategies.
- Collaborate cross-functionally with R&D, manufacturing, quality assurance, legal, and commercial teams to integrate regulatory requirements into product development cycles.
- Monitor global regulatory landscapes, track emerging legislation, and assess potential impact on company products and operations.
- Develop and maintain Safety Data Sheets (SDSs) and product labels in compliance with GHS and country-specific requirements.
- Provide expert regulatory guidance and training to internal stakeholders.
- Represent the company in discussions with regulatory authorities and industry associations as needed.
- Ensure all regulatory documentation is accurate, complete, and maintained according to internal procedures and external requirements.
Required Skills
- Bachelor's degree in Chemistry, Chemical Engineering, Toxicology, or a related scientific discipline.
- Minimum of 6 years of experience in regulatory affairs within the chemical, pharmaceutical, or related industry, with a focus on global compliance.
- In-depth knowledge of major global chemical regulations (e.g., REACH, GHS, TSCA, K-REACH, etc.).
- Proven experience in preparing and submitting regulatory dossiers and managing product registrations.
- Strong analytical and problem-solving skills with meticulous attention to detail.
- Excellent written and verbal communication skills, capable of effectively conveying complex regulatory information.
- Ability to work independently and collaboratively in a fast-paced, multi-cultural environment.
- Proficiency in regulatory software and database management.
Preferred Qualifications
- Master's degree or Ph.D. in a relevant scientific field.
- Certification in Regulatory Affairs (e.g., RAC).
- Experience with product classifications and hazard assessments.
- Familiarity with regulatory requirements for specific product categories (e.g., active pharmaceutical ingredients, specialty chemicals, etc.).
- Experience with SAP EH&S or similar enterprise regulatory management systems.
Perks & Benefits
- Comprehensive health, dental, and vision insurance plans.
- 401(k) retirement savings plan with company match.
- Paid time off, including vacation, sick leave, and company holidays.
- Life and disability insurance.
- Employee assistance program.
- Tuition reimbursement and professional development opportunities.
- On-site fitness center or wellness programs.
- Competitive compensation and performance-based bonuses.
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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