Regulatory Affairs Specialist
hace 4 meses
No Relocation Assistance Offered
162370 - Del.Miguel Hidalgo, Mexico City, Mexico
**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.
If you want to work for a company that lives by their values, then give your career a reason to smile and join our global team
**Position Purpose**:
This position will help to maintain product compliance during the whole life-cycle, for any category of products, regionally, as well as to deliver core dossiers for LATAM, mainly for Cosmetics and Household Products.
**Key Responsibilities**:
- Compile documents and information required for high quality and successful submissions, license renewals, annual registrations, and maintenance of product registration dossiers for authorities.
- Assist the preparation of product dossiers regionally, as well as ensure accurate archiving of all documents submitted to and received from Proficient Authorities, to accurate data timely and keep update regulatory databases and tools for products to comply.
- Update and maintain product registration and ingredients archives, databases and tracking tools.
- Stay abreast of regulations and requirements for Mexico and LatAm region, and provide guidance to business teams with strategic initiatives.
- Lead process simplification and harmonization activities to improve efficiency within the Regulatory Operations team.
- Alert Regional Regulatory Affairs manager of upcoming renewals and commitments in a timely manner.
- Report regularly the progress to the Regional Regulatory Affairs Department with relevant KPIs, particularly in terms of timelines, status of supportive data required from other functions and dossier preparation.
- Keep track of outstanding documentation, notify and advise the manager on a timely manner.
- Work closely with other regions to obtain the relevant documents and information for product dossiers.
- Assist in the preparation of Regulatory Standard Operation Procedures, and in keeping track of revision dates.
- Collect appropriate documentation in order to support regulatory submissions in other countries when products are cross border sourced.
- Artwork Approval:
- Assist the Regional Regulatory Affairs managers in the creation of ingredient list for labeling purposes
- Assist the RA managers with artwork review and approval.
- Regulatory intelligence and product advocacy activities
- Understand current regulations, guidelines and standards relevant to ensure compliance to the applicable regulatory and corporate standards/requirements (medicinal products, medical devices, cosmetic products, biocides, detergents, consumer goods).
- Ensure that the content, organization and overall quality of all regulatory documents are adequate and compliant with local/regional regulatory requirements, commitments and
- agreements.
**Experience and qualifications required**:
- BS degree in Pharmacy, Chemical Pharmaceutical or any related area.
- 3/4+ years of confirmed experience in regulatory affairs, managing formulated Products,quality or product development in the pharmaceutical, medical devices or similar industries.
- Understanding of registration and regulatory requirements of cosmetics, household products, medical devices and pharmaceutical products.
- Knowledge of industry practices, techniques and standards.
- Good written and verbal communicator with excellent interpersonal skills.
- Good planning and organizing skills. Attention to detail and sense of urgency.
- Ability to work under stress and meet deadlines.
- Fluency in spoken and written Spanish is mandatory.
- Advanced English level.
- Good skills in Portuguese language is a plus
**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 & Inclusion**
Achieving our purpose starts with our people — ensuring our workforce represents the people and communities we serve —and creating an environment where our peopl
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