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Job Title : Regulatory Affairs Associate
Travel Required? : Travel - up to 10% of time
Location: Sydney, New South Wales, Australia
Who We Are Colgate-Palmolive Company is a global consumer products company operating in over 200 countries specializing in Oral Care, Personal Care, Home Care, Skin Care, and Pet Nutrition.
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.
Main responsibilities : Provide strategic regulatory advice to the local category teams and other business functions when required.Determine 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.
Compensation and Benefits Salary Range: Pay is determined based on experience, qualifications, and location. Salaried employees may also be eligible for discretionary bonuses, profit-sharing, and long-term incentives for Executive-level roles.
Benefits: Salaried employees enjoy a comprehensive benefits package, including medical, dental, vision, basic life insurance, paid parental leave, disability coverage, and participation in the 401(k) retirement plan with company matching contributions subject to eligibility requirements.
Additional benefits include a minimum of 15 vacation / PTO days (hourly employees receive a minimum of 120 hours) and 13 paid holidays (vacation days are prorated based on the employee's hire date within the calendar year).
Paid sick leave is adjusted based on role and location in accordance with local laws.
Our Commitment to Diversity, Equity & Inclusion Achieving our purpose starts with our people ensuring our workforce represents the people and communities we serve and creating an environment where our people feel they belong;
where we can be our authentic selves, feel treated with respect and have the support of leadership to impact the business in a meaningful way.
Equal Opportunity Employer Colgate is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, sexual orientation, national origin, ethnicity, age, disability, marital status, veteran status (United States positions), or any other characteristic protected by law.
Reasonable accommodation during the application process is available for persons with disabilities.
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