Specialist, Regulatory Affairs
John Paul Mitchell Systems
- Castaic, CA
- Permanent
- Full-time
- Develop and implement regulatory strategies and processes to ensure timely global commercialization of products in compliance with applicable regulations and standards
- Author technical documents for products to be distributed in the EU
- Prepare international documentation to support product registration internationally
- File all new product notifications and update current notifications with Health Canada
- Maintain regulatory archives and product registration databases
- Gather raw material documentation for all JPMS raw materials that could be used in JPMS products and ensure documentation is complete and up to date
- Review documentation received from Manufacturers regarding finished products and file where appropriate
- Keeping abreast of evolving regulations to support our product development and commercialization efforts
- Conduct regulatory assessments of product formulas, packaging, and labeling to ensure compliance with local and international regulations
- Collaborate with quality assurance and R&D teams to ensure compliance with applicable Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), and other relevant quality standards
- Have a strong work ethic and can-do attitude, leaving a positive impression on everyone you interact with
- Collaborate seamlessly with cross-functional stakeholders, fostering a cohesive team environment
- Strong time management skills and able to act with a sense of urgency
- Highly organized, detail oriented and efficient multitasker
- Self-starter and thrives in a fast-paced environment with minimal guidance
- Comfortable wearing many hats and moving fluidly between tasks
- Utilize relevant industry jargon and terminology consistently in both verbal and written communications
- Act and propose new ideas and solutions before asked
- You are positive, upbeat, and friendly-with a can-do attitude and a knack for solving problems
- Self-described beauty enthusiast, passionate about hair care
- Ability to manage multiple regulatory projects with concurrent or competing deadlines while working closely with other team members and departments
- Strong knowledge of federal regulations
- Working knowledge of Internation regulations
- Knowledge of product labeling and related requirements
- Strong experience and knowledge using Microsoft Word, Excel and basic operating systems
- Excellent communication skills (verbal and written)
- Strong presentation skills
- High school diploma or GED required
- Bachelor's degree in science or legal discipline preferred
- 3+ years' experience in Regulatory Affairs in US-FDA regulated product categories
- International experience and global knowledge of cosmetic legislation/registration frameworks preferred
- Experience with the preparation and submission of regulatory documents, such as product registration dossiers and technical files, as well as label review
- Previous experience using Project Lifecycle Management (PLM) systems
- The expected hourly range for this position is $38.46 - $43.46. The hourly rate is determined by various factors including geographic location, experience, skills, and education.
- Discretionary Bonus Plan: This position is also eligible for participation in the company discretionary bonus plan, based on personal performance and company results.
- Comprehensive Benefits Package: In addition to base salary, JPMS offers a competitive benefits package to eligible employees, including medical insurance, dental insurance, vision insurance, life insurance, accident insurance, critical illness insurance, disability insurance, retirement savings plans and company match, paid family leave, education-related programs, paid holidays, discretionary vacation time, and more.
$ 38.46 - $ 43.46Compensation details: 38.46-43.46 Hourly WagePIc55e02cf03ad-8012