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Regulatory Affairs Manager
hace 2 semanas
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Established in 1806 as a small soap and candle business in New York City, Colgate-Palmolive is now a truly global company with products sold in over 200 countries and territories under such internationally recognized brand names as Colgate, Palmolive, Softsoap, Irish Spring, Protex, Sorriso, Kolynos, elmex, Tom's of Maine, Sanex, Ajax, Axion, Soupline, Haci Sakir, Suavitel, PCA SKIN, EltaMD, Filorga and Hello as well as Hill's Science Diet and Hill's Prescription Diet.
Colgate-Palmolive is a leading consumer products company that serves hundreds of millions of consumers worldwide with brands and products across four core businesses – Oral Care, Personal Care, Home Care and Pet Nutrition.
We are committed to offering products that make lives healthier and more enjoyable, and programs that enrich communities around the world.
Every day millions of people trust our products to care for themselves and the ones they love.Our goal is to use our technology to create products that will continue to improve the quality of life for our consumers wherever they live.
A career at Colgate-Palmolive is an excellent opportunity if you seek a global experience, constant challenge, and development opportunities in an environment that respects work/life effectiveness.
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Regulatory Affairs Manager - Andean Region Travel Required?: Travel - up to 10% of time
Dat
e:
May 29, 2024
Hybrid
No Relocation Assistance Offered
# Cali, Valle del Cauca, Colombia
Who We Are
Colgate-Palmolive Company is a caring, innovative growth company that is reimagining a healthier future for all people, their pets and our planet.
Focused on Oral Care, Personal Care, Home Care and Pet Nutrition, we sell our products in more than 200 countries and territories under brands such as Colgate, Palmolive, elmex, hello, meridol, Sorriso, Tom's of Maine, EltaMD, Filorga, Irish Spring, PCA SKIN, Protex, Sanex, Softsoap, Speed Stick, Ajax, Axion, Fabuloso, Soupline and Suavitel, as well as Hill's Pet Nutrition.
We are recognized for our leadership and innovation in promoting sustainability and community wellbeing, including our achievements in decreasing plastic waste and promoting recyclability, saving water, conserving natural resources and improving children's oral health.
The Regulatory Affairs Manager - Andean Region is responsible to lead the Regulatory strategies for the Andean region in order to i) support the business development plans, ii) ensure product compliance and, iii) oversee the liaison and negotiation with the regulatory authorities and trade associations to promote Colgate interests.
Be the Technical Person/Manager overseeing the compliance of the operations (manufacturing and distribution) and products (Cosmetics and Medical Devices) in Colombia.
Be the point person with INVIMAResponsibilities:
Regulatory intelligence, regulatory strategies and external influenceProactively stay up-to-date with regulation changes in the Andean region.
Analyzes and communicates the impact to the key stakeholders (RA Community, Technology, E2E Supply Chain and Business).Deliver Regulatory training and guidance to raise organizational awareness and competency on fundamental Regulatory requirements.
Represent Colgate at the Trade Association (ANDI) and participate in selected working groups at CASIC to influence and promote convergence of the upcoming regulatory changes.
Product registration and product life cycle managementEnsure that all locally produced or imported products meet the technical and legal standards for the Region and are timely authorized for placement on the market.
Lead product registration in accordance with the requirements for the Andean region.This comprises managing the following aspects while not being limited to:
Checking that the claim supports are adequate (clinical and technical studies)
Gathering the required information to obtain registrationReviewing the artworksManage product life cycle activities for the existing products to ensure the registers are up-to-date with the formula and label revisions.
Validating the site Quality Master Plan and contributing to the internal compliance activities (i.e Internal Audits, Assessments, training, OSQ, Copacker Audits, etc.)Providing support in CAPA analysis for consumer complaintsProviding support on special projects that allow improving GMP complianceSupporting the external audits carried out by the Regulatory agency.
Ensure the compliance against the Resolution Nr as regards to the roles and responsibilities of the Technical Director for Medical Devices (numeral 2.1) i.
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Supporting the suppliers and distributors selectionParticipating in the structure of the purchasing processes for imported productsApproving procedures related to storage, packaging, dispatch and distributionEnsuring that storage conditions conform and records are availableProviding training as needed.
Act as the Responsible Person for the manufacture and distribution of Home Care products in Colombia by providing guidance and support.
Organization capabilities and process efficiency Continue to develop the Andean Regulatory Affair organization leveraging on the Leadership Principles (LIFT) and working behaviors (F.E.E.D.).
Leverage on Global Regulatory Operation capabilities to drive efficiencies. Foster a Diverse Equitable and Inclusive environment Ensure timely and effective communication.Be a strong team player with ability to network and collaborate to ensure stakeholders are informed and involved appropriatelyRequirements:
Minimum 7 years' relevant experience in a Regulatory role. In depth expertise in the regulation relevant to Cosmetic and Medical Device in the Andean Region or LATAM. Strong interpersonal and relationship-building skills; ability to engage effectively with all levels and styles of employees and managementSupervisory experience; competency to successfully lead teamsEffective communication and presentation skills, oral and written; high attention to detailStrong critical analysis and decision-makingSolid experience with leading multidisciplinary projectsSelf-starter with high degree of independenceProficiency in Microsoft Office suite or Google tools (Sheets, Slides, Documents) Our Commitment to Sustainability
With the Colgate brand in more homes than any other, we are presented with great opportunities and new challenges as we work to integrate sustainability into all aspects of our business and create positive social impact.
We are determined to position ourselves for further growth as we act on our 2025 Sustainability & Social Impact Strategy.
Our Commitment to Diversity, Equity & InclusionAchieving 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 EmployerColgate 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 contactwith the subject "Accommodation Request" should you require accommodation.
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