Regulatory Affairs Associate
Vor 5 Tagen
About Colgate-PalmoliveDo you want to come to work with a smile and leave with one as well? In between those smiles, your day consists of connecting with others across the world, full of stimulating discussions, and making impactful contributionsIf this is how you see your career, Colgate is the place to be Our dependable household brands, dedicated employees, and sustainability commitments make us a company passionate about building a future to smile about for our employees, consumers, and surrounding communities. We win as a global organization by continually learning and collaborating. The pride in our brand fuels a workplace that encourages creative thinking, champions experimentation, and promotes authenticity which has contributed to our enduring success. If you want to work for a company that lives by their values, then give your career a reason to smile...every single day.Job Summary (Purpose):The Regulatory Affairs Associate is responsible for delivering efficient and effective regulatory strategy based solutions, in collaboration with the Senior Manager, Regulatory Affairs, to deliver optimal business outcomes for Colgate-Palmolive South Pacific, principally Australia and New Zealand subsidiaries across all portfolios - Oral Care, Personal Care, and Home Care.This role offers potential as a Senior Regulatory Affairs Associate, dependent on experience.Main responsibilities:Provide strategic regulatory advice to the local category teams and other business functions when required.Determining the best regulatory strategy for new products and major life cycle projects.Evaluate chemicals, maintain records, and submit SIR, PIR and PID applications to ensure Australian AICIS compliance.Evaluate chemicals, maintain records and submit applications to ensure compliance with NZ EPA requirements.Provide advice, evaluate, compile and submit dossiers to the TGA (Australia) and Medsafe (NZ) to maintain current products or register new products.Oversee electrical product compliance: Assess and maintain record of compliance.Ensure and maintain GMP clearance for all manufacturing facilities.Ensure products remain compliant with all relevant government, industry and corporate requirements throughout their marketed life.Keep abreast of changes in government legislation, industry and corporate requirements that may affect the regulatory status of the company's products.Participate in cross-functional teams to ensure the timely availability of new products to the market and the ongoing success of existing products.Review and provide regulatory advice on promotional materials to ensure compliance with Australian and New Zealand advertising requirements.Review and approve product labelling.Contribute to global regulatory assessments.Collaborate and work effectively with the Regulatory Operations team on all assigned projects.Assist in the review and preparation of feedback to Trade associations and participate in trade associations and working groups as required.Provide effective Regulatory assessments (RAF) for changes to current products, or new product opportunities.Collaborate with the Asia Pacific team on projects as required.Participate in regional/global project initiatives as required.Required (Education, Knowledge required, Language skills, etc):Tertiary qualifications in chemistry, pharmacology, pharmacy or related science.Minimum 3 years experience in a regulatory role in Pharmaceutical and/or FMCG Industry.Robust knowledge of Australian TGA and NZ Medsafe requirements for OTC medicines and Medical Devices.Experience with dossier review, compilation and submission to TGA and Medsafe.Working knowledge of Australian AICIS and NZ EPA requirements.Preferred Requirements:Experience in both Pharmaceutical and Cosmetic FMCG.
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