We are hiring a diligent Regulatory Affairs Specialist to join our dedicated team at Kaztronix in New York, NY.
Growing your career as a Full-Time Regulatory Affairs Specialist is a terrific opportunity to develop vital skills.
If you are strong in attention to detail, adaptability and have the right attitude for the job, then apply for the position of Regulatory Affairs Specialist at Kaztronix today!
This role will support the Global Regulatory Affairs department to propel the hypergrowth and rapid global expansion of the brand. Someone who loves the complexity and detail orientation of global regulatory, thrives in a fast-paced environment, and excels in a passionate, collaborative culture would be successful in this role.
Responsibilities:
- Collaborate closely with business partners to support key business objectives.
- Work with cross functional teams and third parties to obtain regulatory documentation for new and existing products related to testing, production, raw materials, formulas, finished goods, supplier documentation and external certifications.
- Work closely with third party partners and commercial teams to support international registrations, authorizations and product certifications.
- Provide regulatory review of product labels, artwork, manuscripts, information, labels, claims & marketing material to ensure accuracy and compliance.
- Update and maintain Product Information Files (PIF), track documentation, and support key regulatory deliverables to support global registration timelines and product launches.
- Maintain current knowledge of global cosmetic regulations and chemical compliance through ongoing research and data management.
- Compile and organize data for annual reporting requirements and to support product registration requests and cosmetic notification projects.
- Support retailer inquiries, technical documentation requests, and general product questions from various communication platforms.
- Support internal audits and external certification/audits including Vegan and Cruelty Free.
Requirements:
- 1-4+ years of experience in global regulatory affairs- cosmetics, pharmaceuticals, or consumer goods.
- Experience with Veeva - preferred
- Well-organized and able to prioritize in a fast-paced environment, demonstrating dedication and creativity.
- Previous experience in preparing documents for relevant authority submissions (Clinical Trial, Chemistry & Manufacturing, and or Product Registration).
- Strong judgement, attention to detail and the ability to lead multiple projects simultaneously.
- Strong interpersonal, written and verbal communication and analytic skills.
- Ability to coordinate and analyze technical data and identify issues or gaps.
- Strong Microsoft Office skills, including fluency in Microsoft Excel.
- Self-motivated and committed to a team approach.
- Ability to provide innovative solutions within the boundaries of regulation.
- Bachelor's degree in scientific discipline or relevant field, or equivalent.
- Experience with OTC monograph and SPF products, preferred.
- Experience engaging with Global Health Authorities, including the FDA, Health Canada, UK/European Union and China, preferred.
Kaztronix is an equal opportunity employer and does not discriminate on the basis of race, color, national origin, sex, age, religion, disability, veteran status or any other consideration made unlawful by federal, state or local laws. In addition, all human resource actions in such areas as compensation, employee benefits, transfers, layoffs, training and development are to be administered objectively, without regard to race, color, religion, age, sex, national origin, disability, veteran status or any other consideration made unlawful by federal, state or local laws.
By applying to the position, you acknowledge that your information will be used by Kaztronix in processing your application.
Benefits of working as a Regulatory Affairs Specialist in New York, NY:
● Career Growth Potential
● Professional Development Opportunities
● Competitive salary