What are the responsibilities and job description for the Regulatory Affairs Specialist position at Eastridge?
Eastridge Workforce Solutions is a leading provider of workforce management solutions, committed to connecting skilled professionals with meaningful career opportunities. In partnership with a leading manufacturing company, we are seeking an experienced Regulatory Affairs Specialist to support their growing team. The Regulatory Affairs Specialist will assist the Regulatory Affairs Manager with inspections and audits, ensuring compliance. The specialist will also create and maintain essential product, drug documentation, and regulatory statements. If you meet the qualifications listed below and are excited about the opportunity to contribute to a dynamic and growing team, we invite you to apply.
Key Responsibilities:
- Assist the Manager of Regulatory Affairs during cGMP, Environmental, and Regulatory audits.
- Create and collate product master files (dossiers) and drug master files (DMF) with the assistance of the Head of R&D (or designee).
- Generate and review Product CoCs, CoAs, CoMs, BSE documents, CMR documents, RM Certificate of Analysis, Safety Data Sheets, technical documents, RM composition breakdowns, as required for local and international submissions.
- Generate Raw Material Regulatory statements, including Origin Statements, Cruelty-Free statements, Heavy Metal statements, Impurity statements, Food Allergen statements, Fragrance Allergen statements, Nitrosamine-free Statements, PFAs, Benzene, DEG/EG statements, etc.
- Review customer “No-No” lists, Special Store Prohibited lists, Prop 65, REACH-compliant statements, Certified Organic Ingredients, Global and Regional Compliance reports/statements, EU/China-compliant statements, and other global jurisdiction requirements as applicable.
- Coordinate investigations (audit findings, etc.); correspondences to regulatory audits; and registration of products and facilities with agencies.
- Ensure compliance with all SOPs and other regulatory and trade organizational requirements (e.g., FDA, EPA, OSHA, ISO 13485:2003, COSMOS/ECOCERT, etc.).
- Handle facility registrations, renewals, and document submissions to regulatory agencies (e.g., Drug and Cosmetic listings), under the supervision of the Head of Quality/Regulatory.
- Assist the Manager of Regulatory Affairs during periodic quality reviews, regulatory updates, and annual GMP training.
- Familiar with SOP generation processes, Specification controls, and Change Control programs.
- Familiar with quality management systems (QMS) in compliance with 21CFR 210, 211, and 820, and key elements of ISO 13485:2003.
- Maintain familiarity with changing global regulatory requirements.
- Perform compliance assessments and generate compliance reports for new formulas undergoing development as needed to support new product launches.
- Generate, review, and maintain reports related to Cosmos Natural, Cosmos Organic, and NOP reports for ingredients and products.
- Other duties as assigned by the Manager of Regulatory Affairs.
Qualifications:
- Minimum of a Bachelor’s degree in Life Sciences, Engineering, or a related field.
- Experience with drug, cosmetic, and medical device regulatory processes is a prerequisite.
- Familiarity with FDA requirements under 21CFR 210, 211, and 820 is a prerequisite.
- Two or more years of industry or related experience in any combination of cosmetic, medical device, food, or pharmaceutical sectors is required.
- Previous regulatory, inspecting, auditing, or manufacturing experience is a plus.
- Data analysis skills are a plus.
- Computer literacy and effective communication skills are essential.
Benefits:
- Medical, Dental, and Vision Insurance
- Life Insurance
- 401k match
Eastridge Workforce Solutions is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws. We celebrate diversity and are committed to creating an inclusive environment for all employees. Please note that Eastridge is unable to provide visa sponsorship to applicants.
Certain clients require Eastridge to perform background checks and Eastridge will consider qualified applicants with criminal histories in a manner consistent with any applicable federal, state, or local law regarding criminal backgrounds.
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