Regulatory Affairs Associate 163782
Regulatory Affairs Associate 163782
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Job Description
No Relocation Assistance Offered
Job Number#163782 Sydney New South Wales Australia
Who We Are
ColgatePalmolive 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. Our products are trusted in more households than any other brand in the world making us a household name!
Join ColgatePalmolive a caring innovative growth company reimagining a healthier future for people their pets and our planet. Guided by our core valuesCaring Inclusive and Courageouswe foster a culture that inspires our people to achieve common goals. Together lets build a brighter healthier future for all.
Do you want to come to work with a smile and leave with one as well In between those smiles your day consists of working in a global organization continually learning and collaborating having 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. The pride in our brand fuels a workplace that encourages creative thinking champions experimentation and promotes authenticity which has contributed to our enduring success.
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 ColgatePalmolive 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 companys products.
- Participate in crossfunctional 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.
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. Please complete this request form should you require accommodation.
For additional Colgate terms and conditions please click here.
#LIHybrid
Required Experience:
IC
Employment Type
Full Time
