Senior Manager Regulatory Affairs/Head Regulatory Affairs, South ASEAN Hub
3 days ago
No Relocation Assistance Offered
Job Number #165875 - Selangor, Selangor, Malaysia
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. Our products are trusted in more households than any other brand in the world, making us a household name
Join Colgate-Palmolive, a caring, innovative growth company reimagining a healthier future for people, their pets, and our planet. Guided by our core values—Caring, Inclusive, and Courageous—we foster a culture that inspires our people to achieve common goals. Together, let's build a brighter, healthier future for all.
What will you do:
The Regulatory Affairs function plays a crucial role in ensuring that Company's products comply with all the relevant regulations (including compliance related to Halal certification) in the South ASEAN Hub (SAH), which comprises Malaysia, Singapore, Indonesia and Brunei, throughout the products life-cycle as well as developing and implementing approved regulatory external affairs activities and regulatory advocacies.
Responsibilities:
- Lead the South ASEAN Hub Regulatory Affairs team in managing programs and activities related to new product registrations and lifecycle management within the Colgate-Palmolive portfolio, including renewals, variations, notifications, and new license applications.
- Develop and implement regulatory strategies for new categories, claims, or business opportunities that align with both Regional and Global objectives.
- Keep key business partners well-informed about current and evolving regulatory requirements applicable to Colgate's portfolio, delivering information in a clear and comprehensive manner.
- Provide expert regulatory assessments and strategic inputs to facilitate informed decision-making, ensuring that regulatory strategies and actions effectively meet business objectives and regulatory requirements in collaboration with internal stakeholders.
- Ensure compliance with applicable regulations and standards across cosmetics, medicinal products, medical devices, and consumer goods by overseeing the South ASEAN Hub Regulatory Affairs team's submissions and the maintenance of product registration archives.
- Oversee Halal Certification processes, acting as the Halal Executive for operations in Malaysia and as the Halal Supervisor for operations in Indonesia.
- Implement the Halal Assurance System requirements for manufacturing site certification.
- Communicate in a timely manner to the internal stakeholders of new regulations or changes of existing ones that will impact Colgate.
- Direct the compilation of documents and information necessary for high-quality submissions, timely notification renewals, and annual registrations.
- Ensure timely submissions by the South ASEAN Hub Regulatory Affairs team to Competent Authorities and Notified Bodies.
- Foster strong relationships with Regulatory Authorities, Industry Associations, and Halal Certification Authorities.
- Review and approve formulations, ingredient lists, and product artworks for labeling.
- Provide Regulatory Assessments for new formulations/claims/technologies as required for the SAH.
- Ensure all regulatory documents are well-organized, of high quality, and compliant with local and regional requirements.
- Bachelor's degree in pharmacy or life sciences or relevant education. Advanced degree preferred.
- At least 5-7 years of relevant experience in regulatory affairs in FMCG/CPG companies or in pharmaceutical, medical devices or similar companies.
- In-depth understanding of registration and regulatory requirements in South ASEAN Hub.
- Understanding of Halal Certification requirements.
- Knowledge of industry practices, techniques and standards.
- Excellent computer skills, which includes working with electronic databases, eCTD software, MS Office applications, Adobe Acrobat, Internet and Intranet, Google Suite, SAP, DMS, and Authority Regulatory databases.
- Good written and verbal communicator with excellent interpersonal skills.
- Good planning and organizing skills.
- Ability to work under stress and meet deadlines.
- Fluency in spoken and written English. Knowledge of any additional language in SAH (Malaysia, Indonesia) is an advantage.
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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Petaling Jaya, Selangor, Malaysia Colgate-Palmolive Full timeAbout UsWe are Colgate-Palmolive, a caring, innovative growth company reimagining a healthier future for people, their pets, and our planet. Guided by our core values—Caring, Inclusive, and Courageous—we foster a culture that inspires our people to achieve common goals.Job RoleThe Senior Manager Regulatory Affairs/Head Regulatory Affairs, South ASEAN Hub...
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