Regulatory Affairs Manager

hace 4 semanas

Ciudad de México Unilever A tiempo completo

Description

: The successful candidate will co-ordinate the know-how and roll-out of VMS products in South America. Working together with internal or external stakeholders, the candidate will be responsible for the following activities.

Driving detailed business understanding on the different product notification/registration requirements for VMS in South America countries (and international markets outside South America as desirable but not mandatory). Specifically, the candidate will be responsible for:

regulatory landscape overview and regulatory management of VMS products; formulation, ingredients, raw materials, product specifications and claims review; review and approve packaging and marketing materials to comply with local regulations; support with product notification/ registration (dossier preparation for product notification), stability and shelf-life considerations, labelling requirements; liaise with internal stakeholders and authorities' officers to ensure quick and quality submission dossier for notification.

Pro-actively leading the review, impact-assessment and implementation of all applicable regulations and legal requirements (domestic market and exports) operating as a key internal subject matter expert.

Leading the reviewing and interpretation of local new and proposed rules, regulations and enforcement activities impacting the use of ingredients, safety, labeling and advertising, which may have significant impact on planned business actions and/ or proposals.

Ensuring relevant regulatory risk assessments are communicated to relevant functional experts to inform strategy on ingredients, formulations, and any advertising, brand promotion and communication.

Working cross-functionally with internal stakeholders at global and local level to ensure business objectives are met through strong regulatory strategy and partnership.

Directing the activities of external regulatory consultants who may be required as subject matter experts on specific key programs or activities.

Ensure local regulatory compliance (product license renewal, etc…) in liaison with local regulations and corporate policies, global procedures and multifunction team as directed.

Answer customer enquiries and provide best in class solution as required.

Be in direct contact with the local Health Authorities and trade associations. Conduct regulatory activities as requested, based on business needs.

Key skill, attributes and Experience

5+ years of experience in the field of VMS/ consumer healthcare products including cross-functional interactions, technical leadership is essential. Bachelor/Master degree holder in health-related science, Life Science, Regulatory Science, Food Science and Technology; Pharmacy or Medical degree desirable. Knowledge of LatAm regulations and VMS requirements as well as strong understanding of technical regulation (testing and specification) and GMP, GCP, HACCP are required. Ability to assess regulatory risks and opportunities and the impact these may have on the existing and innovation portfolio. Thorough understanding of workflow management, project management, multitasking and managing shifting priorities is required. Knowledge across a wide range of product categories (food/ food supplements/medicines) including manufacturing and technical systems is required. Ability to identify process improvement opportunities to achieve improved, more consistent results and shorter development times is required. R&D knowledge would be desirable, as well experience in Project Management and Digital Tools. Proven facilitation skills, with multitasking and problem-solving attitude. Excellent communication, presentation, and organizational skills, in both spoken and written English, and strong influencing skills. Multi-language speaker is desirable. Strong Team mindset. Ability to collaborate with multiple stakeholders both internally and externally at a global level. Self-motivated & self-starter, proactive and with a high level of initiative and persistence, with a hands-on approach and result-oriented mindset. Enterpreneurial approach and business acumen is required, with a track record of providing solutions and thinking out of the box. Strong execution capabilities with ability to handle multiple assignments and manage major projects to successful completion. Team leadership: experience in a combined global and local team dynamic across all functions.

  • Analyst, Regulatory Affairs

    hace 6 días

    Ciudad de México Olympus Corporation of the Americas A tiempo completo

    **Ubicación MEXICO, MEXICO CITY** ¿Está buscando una empresa que se preocupe por la vida y la salud de las personas, incluida la suya? Inspiremos vidas más saludables, juntos **Olympus, una empresa líder en tecnología médica, se ha centrado en mejorar la vida de las personas durante más de 100 años.** **Nuestro propósito es hacer que la vida de...

  • Senior Manager, Regulatory Affairs

    hace 4 semanas

    México Worldwide Clinical Trials, LLC A tiempo completo

    Who we are We’re a global, midsize CRO that pushes boundaries, innovates and invents because the path to a cure for the world’s most persistent diseases is not paved by those who play it safe. It is built by those who take pioneering, creative approaches and implement them with quality and excellence. We are Worldwide Clinical Trials, and we are a...

  • Regulatory Affairs Specialist

    hace 6 días

    Ciudad Juarez, México BEPC Inc A tiempo completo

    **Regulatory Affairs Specialist** - Develop and maintain regulatory strategies for the development, registration, and commercialization of **medical devices**: - Communicate with regulatory authorities to obtain timely approvals for medical devices - Review and approve labeling, marketing, and promotional materials to ensure compliance with regulations -...

  • Regulatory Affairs Analyst

    hace 3 semanas

    Ciudad de México Viatris A tiempo completo

    Regulatory Affairs Analyst (Fixed Term) page is loaded Regulatory Affairs Analyst (Fixed Term) Postuler locations Mexico City, Mexico time type Temps plein posted on Offre publiée hier job requisition id R5646189 Viatris Healthcare México S. de R.L. de C.V Chez Viatris, nous envisageons la santé non pas telle qu'elle est mais telle qu'elle devrait...

  • Quality Assurance and Regulatory Affairs Analyst

    hace 7 días

    Ciudad de México AlignTech A tiempo completo

    **Join a team that is changing millions of lives.** Transforming smiles, changing lives At Align Technology, we believe a great smile can transform a person’s life, so we create technology that gives people the confidence to take on whatever’s next. We revolutionized the orthodontic industry with the introduction of the Invisalign system, and we have...

  • Regulatory Affairs Manager

    hace 6 días

    México Emprego MX A tiempo completo

    Capital Empresarial Horizonte Empresa Mexicana especialista en Recursos Humanos y Tecnologías de la Información solicita: **Regulatory Affairs Manager** Para laborar en Ciudad de México hibrido ó REMOTO en cualquier otra Ciudad. Perfil Escolaridad: Ingeniería en Sistemas, Informática o afín. Experiência: Mínima de 3 años. Inglés: intermedio...

  • Regulatory Affairs Specialist

    hace 3 semanas

    México Groupe ProductLife A tiempo completo

    In the context of a new project, we are looking for a Regulatory Affairs Specialist to join our teams in Mexico/LATAM. Responsibilities Provide guidance and support about Mexican and Central America legislation Contribute to the regulatory activities performed. Regulatory activities include pre licensing activities, new registration (sites and medicinal...

  • Regulatory Affairs Officer

    hace 4 semanas

    Estado de Chiapas, México Groupe ProductLife A tiempo completo

    In the context of additional activities for one of our main clients, we are looking for a Regulatory Affairs Officer working from Mexico or Canada to manage post-MAA activities (Life Cycle Management) for the Canadian market. Responsibilities Management of post approval activities (Life Cycle Management) for the Canadian market Initiate change...

  • Regulatory Affairs Specialist

    hace 3 semanas

    Ciudad de México Edwards Lifesciences A tiempo completo

    Make a meaningful difference to patients around the world. From design to production, our Regulatory Affairs teams help guide our innovative technologies through complex international regulatory environments. Working in partnership with external government and regulatory authorities, and alongside diverse internal stakeholders, your close attention to...

  • LATAM Government Affairs Manager

    hace 2 semanas

    Ciudad de México Gateway Recruiting A tiempo completo

    Job Responsibilities: As a LATAM Government Affairs Manager, you have the opportunity to tap into your curiosity and collaborate with some of the most innovative and diverse people around the world. Here, you will make an impact by: Establishing, maintaining, and executing a government affairs agenda to include maintenance of a bipartisan contact network...

  • Regulatory Affairs Manager

    hace 7 días

    Ciudad de México Capital Empresarial Horizonte A tiempo completo

    Capital Empresarial Horizonte Empresa Mexicana especialista en Recursos Humanos y Tecnologías de la Información solicita: **Regulatory Affairs Manager** Para laborar en Ciudad de México hibrido ó REMOTO en cualquier otra Ciudad. **Perfil**: Escolaridad: Ingeniería en Sistemas, Informática o afín. Experiência: Mínima de 3 años. Inglés:...

  • Regulatory Affairs Supervisor Latam

    hace 4 semanas

    Huixquilucan de Degollado, México Philips A tiempo completo

    Job TitleRegulatory Affairs Supervisor Latam (Medical Equipment)Job DescriptionJob title:Regulatory Affairs Supervisor Latam (Medical Equipment)Your role:To formulate and implement the HPM Businesses and / or Markets long-range regulatory strategies for LATAM (Latin America).Main point of contact between BU, Market and Local Business Team for product...

  • Regulatory Affairs Specialist

    hace 4 semanas

    Ciudad Juarez, México BEPC Inc A tiempo completo

    Responsible for coordinating, preparing, and maintaining regulatory submissions and documents on a global level for Europe, the United States, and other countries. Primary responsibilities are to ensure regulatory compliance for assigned product lines Other responsibilities include coordinating recalls, identifying relevant standards and guidance documents...

  • Senior Manager Public Affairs and Policy

    hace 4 semanas

    Ciudad de México Pfizer A tiempo completo

    ROLE DESCRIPTION - Support and facilitate interlocution with Government stakeholders to support Pfizer’s business in Mexico. - Contrinbute to the development and implementation of innovative strategic policy and public affairs platforms to advance Pfizer Mexico’s business and policy objectives, including but not limited to engaging government,...

  • Regulatory Legal Manager

    hace 4 semanas

    Ciudad de México Flat.mx A tiempo completo

    **Regulatory Legal Manager** En Flat.mx estamos integrando soluciones para el mercado de bienes raíces en México a través de diferentes productos, enfocándonos en lo más importante: la experiência de nuestros clientes. Nuestro propósito es que todos puedan vivir en el hogar que necesiten cuando lo necesiten, y para eso estamos sacudiendo a la...

  • Regulatory & Nutrition Manager

    hace 4 días

    Ciudad de México Upfield A tiempo completo

    **Regulatory & Nutrition Manager** **México** ¡Nuestro equipo de R&D está en búsqueda de talento! En esta posición coordinarás, verificarás y asegurarás el cumplimiento y seguimiento de los asuntos regulatorio con las diferentes autoridades sanitarias de Latinoamérica, estableciendo y ejecutando las estrategias más adecuadas para el sometimiento...

  • External Affairs Manager

    hace 4 semanas

    México Bacardi-Martini A tiempo completo

    Posted 17-Apr-2024 Job type Full time Country Mexico Location Tultitlan, Mexico Lead recruiter Abril Lugo Function Legal Corporate Affairs Reporting Line Legal Director Latinoamerica & Caribbean On-site/Remote On-site Level of experience Professional (Management) Contract type Permanent YOUR OPPORTUNITY Your Opportunity This is a unique opportunity to be...

  • Head of Regulatory Sciences

    hace 7 días

    Ciudad de México Pfizer A tiempo completo

    JOB SUMMARY - Lead, manage and provide strategic direction to the country regulatory team. - Accountable for all strategic regulatory activities for the country including pre - and post-authorization product lifecycle activities and delivery of operational regulatory activities in partnership with above-country operational hubs. - Deliver country strategic...

  • Regulatory Specialist Latam

    hace 4 semanas

    Ciudad de México Tiger Text A tiempo completo

    Company Description The legal team protects Red Bull, its people, partners and vendors by adding value to each product line and initiative. Legal is divided into Legal Business Partners for the Beverage Business and Corporate Projects, Specialist Departments and Centers of Expertise. The Regulatory Specialist assists the LATAM Regional team by offering...

  • Gerente Asuntos Regulatorios

    hace 2 semanas

    Ciudad de México, Ciudad de México Nestlé A tiempo completo

    Regulatory & Scientific Affairs Jr Manager CMDXMain mission as a RSA Manager for Nestlé Mexico is to ensure functional leadership both internally and externally on specific regulatory topics through the development of Group's positions and policies. You will also represent Nestlé in influencing activities with national authorities under the scope of the...