Regulatory Affairs Specialist

3 weeks ago

Sydney, New South Wales, Australia Colgate-Palmolive Company Full time

About the Role:
We are seeking a Regulatory Affairs Associate to join our team at Colgate-Palmolive Company. As a key member of our Regulatory Affairs function, you will be responsible for delivering efficient and effective regulatory strategy solutions to support the optimal business outcomes for our South Pacific subsidiaries.

Key Responsibilities:


  • Provide strategic regulatory advice to local category teams and other business functions.
  • 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 records 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 life cycle.
  • Stay up-to-date with changes in government legislation, industry, and corporate requirements affecting the regulatory status of our products.
  • Participate in cross-functional teams to ensure timely product availability and ongoing product success.
  • Review and provide regulatory advice on promotional materials to ensure compliance with Australian and New Zealand advertising requirements.
  • Review and approve product labeling.
  • Contribute to global regulatory assessments.
  • Collaborate with the Regulatory Operations team on assigned projects.
  • Assist in reviewing and preparing feedback to trade associations and participate in trade associations and working groups as required.
  • Provide effective Regulatory Assessments (RAF) for product changes or new opportunities.
  • Collaborate with the Asia Pacific team on projects as needed.
  • Participate in regional/global project initiatives as required.

Requirements:


  • Tertiary qualifications in chemistry, pharmacology, pharmacy, or a related science.
  • Minimum 3 years of experience in a regulatory role in the Pharmaceutical and/or FMCG industry.
  • Strong 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.

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.

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