Regulatory Affairs Associate

Company DescriptionWeckerle Cosmetics is a premier global solutions provider in the cosmetics industry, delivering innovative contract manufacturing services for beauty products across lips, eyes, face, and body. For over 30 years, Weckerle has been a leader in cutting-edge science, advanced machine manufacturing technology, and sophisticated packaging design for leading brands. As one of the few true full-service cosmetics manufacturers, Weckerle specializes in creating tailor-made solutions, offering services ranging from formulation filling to concept realization. Headquartered in Torrance, CA, Weckerle remains committed to setting benchmarks in the global cosmetics industry.Role DescriptionThe Regulatory Affairs Associate is a full-time, on-site role located in Torrance, CA. The primary responsibilities include preparing regulatory documentation, ensuring compliance with worldwide regulatory requirements, and managing the submission of regulatory filings. This role involves collaborating with internal teams to ensure all processes meet industry standards, keeping updated with regulatory changes, and maintaining meticulous records to support audits and inspections.QualificationsStrong expertise in preparing and managing Regulatory Documentation and Regulatory SubmissionsIn-depth understanding of Regulatory Compliance and adherence to Regulatory RequirementsProven experience in Regulatory Affairs, including working knowledge of industry-specific regulations and compliance standardsExcellent organizational and attention-to-detail skills, with the ability to manage multiple projects simultaneouslyStrong written and verbal communication skillsBachelor's degree in a relevant science or regulatory disciplineFamiliarity with cosmetic or related industries is an advantageProficiency with regulatory software and tools is preferredEssential Duties and Responsibilities:       1.    Establish and maintain product dossier for each product manufactured in the Torrance facility. Collect all document of received and inspected incoming:                           Packaging and Components a.    Inspected and approved labelling and artwork b.    Track any non-conformancesc.    Store example of all product components and master in product dossier Raw Materials a.    Raw materials receiving and validation documents b.    Collect and store in product dossier all appropriate documents mandated by US MoCRA requirements and as outlined by customer claim and international distribution plans. Collect approved batch record from production and QC on each run of product.  Create Finish Good Safety data sheets with support of R&D and QCDevelop and maintain library with all appropriate document for ingredient, components and other form factors used by company based on Microsoft Dynamics AX              2.    Understand and communicate cosmetic regulations, guidelines, and standards to internal teams. 3.    Understand cosmetic and OTC regulatory requirements and support regulatory department to ensure products are in compliance with regional and international regulations4.    Understand cosmetic product labeling and packaging and support regulatory department to ensure products are in compliance with regional and international regulations5.    Manage tracking system of all inquiries, submissions, and requests for information from customers or other departments for the regulatory department.Other Duties and Responsibilities:Other duties and projects assigned by manager.Supervisory Responsibilities:This job has no supervisory responsibilities.Qualifications/Requirements:Proficiency in Microsoft Excel., Microsoft Word, and Microsoft outlook. EDUCATION:Bachelors in related discipline or equivalency.EXPERIENCE: Minimum 1 years working experience in the same field.KNOWLEDGE/SKILLS/ABILITIES:Knowledge:·             Standard, clerical office practices and procedures especially as they relate to the function of this position. ·             Working knowledge of MS Office, Word and Excel.SkillsStrong written and verbal communication skills, needed to effectively communicate with, Management, guests, customers, vendors, suppliers, etc.Ability to focus in a busy environment.Ability to manage and prioritize multiple projects. Abilities:Speak and write effectively; prepare documents that are succinct, (priority, high area of interest), and grammatically accurate; correctly apply policies, procedures, and regulations. Work effectively in a diverse community; maintain confidences, and confidentiality. Attention to detail and the ability to work on multiple tasks simultaneously, is critical for the success of this position.Physical Demands:The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this Job, the employee is regularly required to use hands to finger, handle, or feel; reach with hands and arms and talk or hear. The employee is frequently required to sit. The employee is occasionally required to stand and walk. The employee must occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this job include close vision and color vision.Work Environment·               The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.   Special Requirements:·                                 Ability to work effectively with a diverse community.