Marisol Granados Amateco
Gerente de Asuntos Regulatorios México y LATAM at Sinclair México- Claim this Profile
Click to upgrade to our gold package
for the full feature experience.
Topline Score
Bio
Julián Palacio C.
I had the opportunity to work with Marisol for two years and she demonstrated exceptional skills and knowledge in regulatory affairs. She has a deep understanding of the regulatory environment and can navigate complex regulations with ease. Her attention to detail and ability to think critically have been invaluable in ensuring our products meet regulatory requirements. Marisol has also been a dedicated team player, willing to take on additional responsibilities when necessary and always willing to lend a helping hand to her colleagues. Her excellent communication skills have been particularly noteworthy, as she has been able to communicate complex regulatory information in a clear and concise manner to both internal and external stakeholders.
Melissa Bustamante
Marisol has been a strategic lead with high level of technical knowledge and built experience through the years in the medical devices-Reg Affairs field. She is an excellent colleague that has gained key skills in her roles with local, regional and Global J&J teams; and has been an amazing partner with developed critical understanding and effective mindset. I’ve seen her continuous growth and construction of robust professional career.
Julián Palacio C.
I had the opportunity to work with Marisol for two years and she demonstrated exceptional skills and knowledge in regulatory affairs. She has a deep understanding of the regulatory environment and can navigate complex regulations with ease. Her attention to detail and ability to think critically have been invaluable in ensuring our products meet regulatory requirements. Marisol has also been a dedicated team player, willing to take on additional responsibilities when necessary and always willing to lend a helping hand to her colleagues. Her excellent communication skills have been particularly noteworthy, as she has been able to communicate complex regulatory information in a clear and concise manner to both internal and external stakeholders.
Melissa Bustamante
Marisol has been a strategic lead with high level of technical knowledge and built experience through the years in the medical devices-Reg Affairs field. She is an excellent colleague that has gained key skills in her roles with local, regional and Global J&J teams; and has been an amazing partner with developed critical understanding and effective mindset. I’ve seen her continuous growth and construction of robust professional career.
Julián Palacio C.
I had the opportunity to work with Marisol for two years and she demonstrated exceptional skills and knowledge in regulatory affairs. She has a deep understanding of the regulatory environment and can navigate complex regulations with ease. Her attention to detail and ability to think critically have been invaluable in ensuring our products meet regulatory requirements. Marisol has also been a dedicated team player, willing to take on additional responsibilities when necessary and always willing to lend a helping hand to her colleagues. Her excellent communication skills have been particularly noteworthy, as she has been able to communicate complex regulatory information in a clear and concise manner to both internal and external stakeholders.
Melissa Bustamante
Marisol has been a strategic lead with high level of technical knowledge and built experience through the years in the medical devices-Reg Affairs field. She is an excellent colleague that has gained key skills in her roles with local, regional and Global J&J teams; and has been an amazing partner with developed critical understanding and effective mindset. I’ve seen her continuous growth and construction of robust professional career.
Julián Palacio C.
I had the opportunity to work with Marisol for two years and she demonstrated exceptional skills and knowledge in regulatory affairs. She has a deep understanding of the regulatory environment and can navigate complex regulations with ease. Her attention to detail and ability to think critically have been invaluable in ensuring our products meet regulatory requirements. Marisol has also been a dedicated team player, willing to take on additional responsibilities when necessary and always willing to lend a helping hand to her colleagues. Her excellent communication skills have been particularly noteworthy, as she has been able to communicate complex regulatory information in a clear and concise manner to both internal and external stakeholders.
Melissa Bustamante
Marisol has been a strategic lead with high level of technical knowledge and built experience through the years in the medical devices-Reg Affairs field. She is an excellent colleague that has gained key skills in her roles with local, regional and Global J&J teams; and has been an amazing partner with developed critical understanding and effective mindset. I’ve seen her continuous growth and construction of robust professional career.
Experience
-
Sinclair México
-
Mexico
-
Medical Equipment Manufacturing
-
1 - 100 Employee
-
Gerente de Asuntos Regulatorios México y LATAM
-
Apr 2023 - Present
Industria estética y cosmética Industria estética y cosmética
-
-
-
Johnson & Johnson
-
Law Practice
-
1 - 100 Employee
-
LATAM Regulatory Affairs Strategy Lead
-
Jan 2022 - Mar 2023
Cardiovascular Special Solutions (CSS- franchise) & Ethicon franchise. Cardiology, Energy platform, Suture, Coils, Equipment and Breast implants products.Responsible to Launch Excellence process in LATAM for CSS and ETH franchise 110 new products during 2022. Close relationship with Regional Marketing (MKT) to perform the business plan: RA strategy, cost, and timelines. Align with Global RA the implementation: approvals Vs documents availability and timelines. Close communication with countries and indirect markets (distributors) to align MKT expectations. Notify to Regional Supply Chain (SC) team impacts to avoid product disruption. Participate and contribute to the Global Planning sessions, Stage gates. Contribute to elaborate the Business plan. Close communication with Originating Companies (OC) to get documentation on time. Keep RA procedures updated. Participate in regional audits. Show less
-
-
Regional Regulatory Affairs Supervisor (3 reports)
-
Jul 2019 - Dec 2021
CSS (Cardiovascular Solutions) & Ethicon franchises. Support Regional Projects or strategies to maintain the business as Marketing needs in LATAM countries. Connect with Regional Marketing to launch new products and keep base business. Align with Global RA the impact and implementation of product changes. Notify to Regional Supply Chain team the impacts on changes and product disruptions. Participate and contribute in the Global Planning sessions. Close communication with Originating Companies (OC) to obtain the legal and technical documentation on time. Request and provide submission evidence package for new products introduction/development, renewals, and changes (2020 – 120 processes/15 strategies and 2021 -100 processes /20 strategies). Show less
-
-
Global Regulatory Affairs Supervisor (1 report)
-
Dec 2017 - Jul 2019
Regulatory Affairs Life Cycle Innovation (RALI) /CSS- franchise Global Strategy Execution Team (GSET)Cardiology, Sterilization products and Breast implants.Member of the Originating Company, to provide legal and technical documents for Breast implants products to worldwide countries.Comply the estimated reception date of documents to guaranty the submission and approval date committed to launch day in different countries around the world. Liaison with global marketing to define the portfolio to launch in EMEA countries. Connection with international supply chain, engineers of the products and quality area of the originating company for special requests. Request Certificates of Foreign Government to FDA website and CFS to European team. Elaborate Global or Regional dossiers in advance to worldwide countries for new products. Provide technical information to worldwide countries for renewal processes to maintain the core business. Show less
-
-
LatAm Senior Regulatory Affairs (3 reports)
-
Nov 2015 - Dec 2017
Dossier Excellent Group (DEG) Nov 2015 to Dec 2017Elaborate regional dossiers to LATAM countries, these New products for all franchises (Orthopedics, Cardiology, Energy, Sterilization, Breast implants and Suture products) managed in the Medical Device business, including local translations. Contribute in some projects as: Prioritization tool, Planning & Execution Working group. Lead the team to comply the plan in compliance.
-
-
Mexico - Senior Regulatory Affairs Specialist (5 reports)
-
Jul 2011 - Nov 2015
Jul 2013 -Nov 2015. – Portfolio: Cardiology, Energy, Sterilization, In Vitro Diagnostics, Medicines, Medicated Devices, Hemostatic and biologic products. Jul 2011 - Jun 2013. – Portfolio: Orthopedics (prosthetics & instruments).Core business: Medical Device Registrations and New product introduction. Leading projects for new registrations, changes, renewals, advertisings. Prepares submissions to the HA for approval, manage divestitures. Coordinate and ensure the regulatory plan (monthly and yearly) according to budget. Develop Regulatory strategies and coordinate submission process to the regulatory agency. Close collaboration with local marketing to launch new products. Relationship with third parties pre-reviewed of dossiers, associations such as AMID & CANIFARMA. Direct contact to OC in different countries (LatAm, USA and Europe).Other projects included: Support Bid, Supply chain liaison, Records Information Management Coordinator, Local champion of TrackWise system (Registration data base), Plan reports, Dashboards, Quality Point of Contact (managed: CAPA’s, Recall’s, and escalations in RA Mexico), Techno-vigilance requirements. Coordinate analysts to complete the plan. (seems like this is part of the strategy evaluation). Show less
-
-
Regulatory Affairs Associate
-
Jun 2009 - Jun 2011
Orthopedics (prosthetics & instruments)Coordinate dossier preparation for the timely submission of diverse processes: Ensure processes are submitted according to monthly planning, Assure high quality submissions, Databases update, Registration approval communication.
-
-
Regulatory Affairs Analyst for renewal project (Outsource contract)
-
Oct 2007 - Jun 2009
Preparation and submission of 200 renewals in 2 years. (Elaborate 200 registrations renewals for orthopedic products as part of the core business).
-
-
-
Farmacos Especializados
-
Mexico
-
Pharmaceutical Manufacturing
-
1 - 100 Employee
-
Auxiliar de Resonsable Sanitario
-
Jan 2007 - Oct 2007
-
-
Education
-
2012 - 2014
Universidad Nacional Autónoma de México
Master's degree, Administración en Sistemas de Salud -
2002 - 2006
ENCB IPN
QFI, Química médica y farmacéutica
Community
