Job Title: Senior Regulatory Affairs Associate
No Relocation Assistance Offered
# 154553 - Sydney, New South Wales, Australia
About Colgate-Palmolive
Do 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 contributions!
If 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) :
Work with the immediate Manager to deliver efficient and effective regulatory strategy based solutions 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.
- 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 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 all aspects of electrical product compliance.
- Ensure and maintain GMP clearance for all manufacturing facilities.
- Ensure products remain aligned with all relevant government, industry and corporate requirements throughout their marketed life.
- Stay on top 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.
- Collaborate and work optimally 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 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 5 years experience in a regulatory role in Pharmaceutical and/or FMCG Industry.
- Attention to detail and effective communication skills.
- Robust knowledge of Australian TGA and NZ Medsafe requirements for OTC medicines and Medical Devices.
Preferred Requirements:
- Experience in both Pharmaceutical and Cosmetic FMCG.
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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.
Are you interested in working for Colgate-Palmolive? You can apply online and attach all relevant documents such as a cover letter and resume or CV. Applications received by e-mail are not considered in the selection process. Become part of our team. We look forward to your application.
Colgate-Palmolive is a leading global consumer products company, tightly focused on Oral Care, Personal Care, Home Care and Pet Nutrition. Colgate sells its products in over 200 countries and territories around the world under such internationally recognized brand names as Colgate, Palmolive, elmex, Tom’s of Maine, Sorriso, Speed Stick, Lady Speed Stick, Softsoap, Irish Spring, Protex, Sanex, Elta MD, PCA Skin, Ajax, Axion, Fabuloso, Soupline and Suavitel, as well as Hill’s Science Diet and Hill’s Prescription Diet.
For more information about Colgate’s global business, visit the Company’s web site at http://www.colgatepalmolive.com. To learn more about Colgate Bright Smiles, Bright Futures® oral health education program, please visit http://www.colgatebsbf.com. To learn more about Hill's and the Hill’s Food, Shelter & Love program please visit http://www.hillspet.com. To learn more about Tom’s of Maine please visit http://www.tomsofmaine.com.
Reasonable accommodation during the application process is available for persons with disabilities. Please contact Application_Accommodation@colpal.com with the subject "Accommodation Request" should you require accommodation.
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