Job Title:  Senior Manager Regulatory Affairs/Head Regulatory Affairs, South ASEAN Hub

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.
 

About Us:

We are Colgate, a caring, innovative growth company that is reimagining a healthier future for people, their pets, and our planet. Crafted by an unwavering dedication to integrity in everything we do, our strong culture of collaboration, inclusion and excellence is rooted in our core values of Caring, Global Teamwork and Continuous Improvement.

People are our greatest strength. We win together by bringing to bear the talent, diversity and creativity of each individual and collaborating and building on excellent ideas to bring them to life.

If you are the one who has a growth mindset and loves to learn, lead and encourage; likes to experiment; loves all things digital; and if you want to be a part of a company that lives by their values, then give your career a reason to smile... every single day!

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. Collaborate with Regional and Global teams to create product dossiers and necessary documentation for market readiness.

• Oversee Halal Certification processes, acting as the Halal Executive for operations in Malaysia and as the Halal Supervisor for operations in Indonesia, ensuring that all products and ingredients meet Halal standards and certification requirements.

• Implement the Halal Assurance System requirements for manufacturing site certification, organizing periodic training sessions for staff and ensuring ongoing adherence through regular refresher training and audits.

• Communicate in a timely manner to the internal stakeholders of new regulations or changes of existing ones that will impact Colgate and work with relevant stakeholders to develop Colgate strategy for compliance to new regulations.

• Direct the compilation of documents and information necessary for high-quality submissions, timely notification renewals, and annual registrations. Guide the South ASEAN Hub Regulatory Affairs team to maintain comprehensive product registration dossiers for submission to authorities.

• Ensure timely submissions by the South ASEAN Hub Regulatory Affairs team to Competent Authorities and Notified Bodies, securing prompt approvals for new products and lifecycle submissions.

• Foster strong relationships with Regulatory Authorities, Industry Associations, and Halal Certification Authorities. Actively participate and lead roles in relevant Trade Associations and Technical Working Groups when necessary.

• Review and approve formulations, ingredient lists, and product artworks for labeling, ensuring compliance with the applicable rules and regulations within the South ASEAN Hub.

• Provide Regulatory Assessments for new formulations/claims/technologies as required for the SAH and also assist the regional regulatory team to deliver and manage regulatory assessments.

• Ensure all regulatory documents are well-organized, of high quality, and compliant with local and regional requirements. Monitor updates from Competent Authorities, support Regulatory Assessments for new formulations or technologies, and play an active role in key regulatory meetings, providing timely feedback.

 Who Are We Looking For:

• 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. Experience of managing Halal Certification requirements will be an added advantage.

• Knowledge of industry practices, techniques and standards.

• Knowledge and experience with medicinal products and medical devices is an advantage.

• Excellent computer skills, which includes working with electronic databases, eCTD software, MS Office applications (working with templates, and editing and formatting complex documents), Adobe Acrobat Standard or Professional, Internet and Intranet, Google Suite, SAP, DMS, and Authority Regulatory databases and portals for managing changes and submissions.

• 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.

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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. Please complete this request form should you require accommodation.

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