Empleos actuales relacionados con Regulatory Sciences Manager - Ciudad de México, Ciudad de México - Pfizer
-
Regulatory Affairs Manager
hace 1 semana
Ciudad de México, Ciudad de México Gilead Sciences, Inc. A tiempo completoAbout the RoleWe are seeking a highly skilled Regulatory Affairs Manager to join our team in Mexico City. As a key member of our Regulatory Affairs team, you will be responsible for developing and executing regulatory strategies to maximize regulatory success and ensure compliance with applicable regulatory requirements.This is an exciting opportunity for an...
-
Regulatory Affairs Manager
hace 2 semanas
Ciudad de México, Ciudad de México Gilead Sciences A tiempo completoJob DescriptionWe are seeking a highly skilled and experienced Regulatory Affairs professional to join our team at Gilead Sciences. As a Regulatory Affairs Manager, you will play a critical role in advancing our therapeutics and ensuring regulatory compliance.Key ResponsibilitiesDevelop and Execute Regulatory Strategies: Define, develop, and execute...
-
Regulatory Affairs Manager
hace 1 semana
Ciudad de México, Ciudad de México Gilead Sciences, Inc. A tiempo completoJob SummaryWe are seeking a highly skilled Regulatory Affairs Manager to join our team at Gilead Sciences, Inc. in Mexico City. As a key member of our Regulatory Affairs team, you will be responsible for developing and executing regulatory strategies to ensure compliance with applicable regulations and maximize regulatory success.This is an exciting...
-
Regulatory Affairs Manager
hace 4 días
Ciudad de México, Ciudad de México Gilead Sciences A tiempo completoJob DescriptionFor Current Gilead Employees and Contractors:Please log onto your Internal Career Site to apply for this job.Gilead Sciences is a leading biopharmaceutical company dedicated to creating a healthier world for all people. With over 35 years of experience, we have developed therapies for diseases such as HIV, viral hepatitis, COVID-19, and...
-
Regulatory Affairs Manager
hace 7 días
Ciudad de México, Ciudad de México Gilead Sciences A tiempo completo{"h1": "Regulatory Affairs Manager", "h2": "Therapeutic Advancement", "p": "At Gilead Sciences, we're committed to creating a healthier world for all people. Our mission requires collaboration, determination, and a relentless drive to make a difference. As a Regulatory Affairs Manager, you'll play a critical role in the discovery and development of...
-
Regulatory Affairs Manager
hace 7 días
Ciudad de México, Ciudad de México Gilead Sciences A tiempo completoJob DescriptionFor Current Gilead Employees and Contractors:Please log onto your Internal Career Site to apply for this job.About Gilead SciencesGilead Sciences is a leading biopharmaceutical company dedicated to creating a healthier world for all people. With over 35 years of experience, we've developed therapies that improve lives and ensure access to...
-
Regulatory Affairs Manager
hace 5 días
Ciudad de México, Ciudad de México Gilead Sciences Mexico, S. de R.L. de C.V. A tiempo completoRegulatory Affairs ManagerWe are seeking a highly skilled Regulatory Affairs Manager to join our team at Gilead Sciences Mexico, S. de R.L. de C.V. This is an exciting opportunity for an experienced regulatory professional to contribute to the success of our organization.Key Responsibilities:Develop and execute regulatory strategies to ensure compliance with...
-
Regulatory Affairs Manager
hace 2 semanas
Ciudad de México, Ciudad de México Gilead Sciences, Inc. A tiempo completoAbout the RoleWe are seeking a highly skilled Regulatory Affairs Manager to join our team at Gilead Sciences, Inc. in Mexico City. As a key member of our Regulatory Affairs team, you will play a critical role in advancing our therapeutics and ensuring regulatory compliance.Key ResponsibilitiesRegulatory Strategy DevelopmentDefine and execute regulatory...
-
Regulatory Affairs Manager
hace 1 semana
Ciudad de México, Ciudad de México Gilead Sciences Mexico, S. de R.L. de C.V. A tiempo completoJob SummaryGilead Sciences Mexico, S. de R.L. de C.V. is seeking a highly skilled Regulatory Affairs Manager to join our team in Mexico City. As a key member of our Regulatory Affairs team, you will be responsible for developing and executing regulatory strategies to ensure compliance with applicable regulations and maximize regulatory success.Key...
-
Regulatory Affairs Senior Manager
hace 2 semanas
Ciudad de México, Ciudad de México Gilead Sciences A tiempo completoJob OverviewFor Current Gilead Employees and Contractors:Please log onto your Internal Career Site to apply for this position.At Gilead, we are dedicated to fostering a healthier world for everyone. For over 35 years, we have addressed critical health issues such as HIV, viral hepatitis, COVID-19, and cancer, tirelessly working to develop therapies that...
-
Manager of Regulatory Compliance
hace 2 semanas
Ciudad de México, Ciudad de México Gilead Sciences A tiempo completoJob OverviewFor Current Gilead Employees and Contractors:Please log onto your Internal Career Site to apply for this position.At Gilead, we are dedicated to fostering a healthier world for everyone. With over 35 years of experience, we have addressed significant health challenges such as HIV, viral hepatitis, COVID-19, and cancer. Our commitment to...
-
Senior Manager of Regulatory Affairs
hace 2 semanas
Ciudad de México, Ciudad de México Gilead Sciences A tiempo completoJob OverviewFor Current Gilead Employees and Contractors:Please log onto your Internal Career Site to apply for this job.At Gilead, we are dedicated to fostering a healthier future for all individuals. For over 35 years, we have addressed significant health challenges such as HIV, viral hepatitis, COVID-19, and cancer, tirelessly working to develop therapies...
-
Compliance Strategist
hace 2 semanas
Ciudad de México, Ciudad de México Gilead Sciences A tiempo completoJob DescriptionAbout the RoleWe are seeking a highly skilled and experienced Regulatory Affairs professional to join our team at Gilead Sciences. As a Regulatory Affairs Manager, you will play a critical role in advancing our therapeutics and ensuring regulatory compliance.Key ResponsibilitiesDevelop and execute regulatory strategies to maximize regulatory...
-
Regulatory Affairs Manager
hace 2 semanas
Ciudad de México, Ciudad de México Gilead A tiempo completoAbout GileadGilead is a leading biopharmaceutical company dedicated to creating a healthier world for all people. With over 35 years of experience, we have developed therapies that improve lives and ensure access to these therapies across the globe.We are a collaborative and ambitious team that tackles the world's biggest health challenges. Our employees are...
-
Regulatory Compliance Specialist
hace 2 semanas
Ciudad de México, Ciudad de México IQVIA A tiempo completoJob SummaryWe are seeking a highly skilled Regulatory Compliance Specialist to join our team at IQVIA in a Home-Based role. The successful candidate will be responsible for performing tasks at a country level associated with Site Activation (SA) activities in accordance with applicable local and/or international regulations, standard operating procedures...
-
Regulatory Specialist for Clinical Research
hace 1 semana
Ciudad de México, Ciudad de México IQVIA A tiempo completoRegulatory & Start Up SpecialistWe are seeking a highly skilled Regulatory & Start Up Specialist to join our cFSP team in a Home Based role.Key Responsibilities:Perform country-level tasks associated with Site Activation (SA) activities in accordance with local and international regulations, SOPs, project requirements, and contractual guidelines.Act as the...
-
Regulatory Policy Manager
hace 2 semanas
Ciudad de México, Ciudad de México HSBC A tiempo completoJob Summary:We are seeking an experienced professional to join our team in the role of Manager, Global Regulatory Policy at HSBC. As a key member of our Global Service Center, you will play a critical role in shaping our regulatory policy and ensuring compliance with industry standards.About the Role:The Global Regulatory Policy and Advisory (GRPA) team is a...
-
Regulatory Affairs Director
hace 7 días
Ciudad de México, Ciudad de México Pharmanovia A tiempo completoAbout the Role:We are seeking a highly experienced Regulatory Affairs professional to lead the establishment of Regulatory Affairs management in the LATAM region for Pharmanovia, a dynamic and fast-growing international pharmaceutical company.As Regulatory Affairs Manager, you will be responsible for all aspects of the LATAM Regulatory Strategy, supporting...
-
Regulatory Policy Manager
hace 2 semanas
Ciudad de México, Ciudad de México HSBC A tiempo completoJob Summary:We are seeking an experienced professional to join our team in the role of Manager, Global Regulatory Policy at HSBC. As a key member of our Global Service Center, you will play a critical role in shaping our regulatory policy and ensuring compliance with industry standards.About the Role:The Global Regulatory Policy and Advisory (GRPA) team is a...
-
Regulatory Affairs Manager
hace 2 semanas
Ciudad de México, Ciudad de México Upfield A tiempo completoJob SummaryWe are seeking a highly skilled Regulatory Affairs Manager to join our team at Upfield in Mexico City. As a key member of our Regulatory Affairs team, you will be responsible for ensuring compliance with regulatory requirements in Central and Latin America.Key ResponsibilitiesDevelop and implement regulatory strategies to support product...
Regulatory Sciences Manager
hace 3 meses
Why Patients Need You
We're looking to bring medicines to the world faster and we are not willing to compromise on excellence and integrity. Adhering to local and global regulations is essential and the ever-changing regulatory environment requires forward thinking and attention to detail. Your dedication and expertise will help expand and accelerate patient access to Pfizer medicines and vaccines.
What You Will Achieve
You will represent Pfizer as an Approval Liaison in the regulatory affairs team. You will play the critical role of providing strategic product direction to teams while interacting with regulatory agencies and negotiating with them to expedite approval of pending registrations. Due to your expertise, you will be the Regulatory Liaison on the project team throughout the product lifecycle and a regulatory representative to marketing or research project teams and government regulatory agencies. Your understanding of regulatory procedures will help in development of submission of product registration, progress reports, supplements, amendments, and periodic experience reports.
As aManager, your breadth of knowledgeoninternal or external business challenges will help us improve our products, processes and services. Your will guide us to lead projects by meeting objectives and preparing forecasts for resource requirements. Your risk-taking ability will help us advance new concepts and methodologies. You will provide technical guidance and oversight to team members and help in problem solving.
It is your hard work and commitment that will make Pfizer ready to achieve new milestones and help patients across the globe.
How You Will Achieve It
Manage multiple projects/ ongoing work activities within the department typically involving cross-functional representatives. Provides technical, functional guidance and oversight to teammembers withinthe department. Ensure that quality standards are met and that the deliverables meet strict deadlines and fulfil local regulatory standards. Ensure local licenses undercountryresponsibility are maintained in compliance with local regulations and following corporate policies, regulatory processes,andStandard Operating Procedures (SOP). Work with Global Product Owners and cross functional team to ensure preparation and submission of Global Annual Reports (AR) for NDAs &ANDAs(Abbreviated New Drug Application). Act as the Regulatory Lead for Life Cycle management (LCM) and work with regulatory strategist and cross functional teams to ensure preparation of quality global regulatory strategy document and supplements/variations. Update the assignedlocalproductdocuments in consistency with the local regulations and in the related systems. Manage and oversee all relevant maintenance activities potentially including Life Cycle management strategy. Identify andassessesregulatory risks associated with assigned projects and timely communication to the leadership team to quickly mitigate the risks. Drive resolution of identified issues by communicating issue, impact and outcomes to global regulatory management and core team. Negotiate with andinfluencesmanagement ,cross functional teams andcolleagues toensure project timelines and quality expectations are met. Manage the budget and resources allocated to the Regulatory Teams. Set objectives and manage team performance to achieve best outcomes for business, ensure right training and upskill plans for team.Qualifications
Must-Have
Bachelor's Degree(BA/BS)and 5+ years of experience. Demonstrated ability to apply regulatory guidelines/regulations to successful dossier preparation, submission,and maintenance. Strong analytical skill and technical/ scientific competence. Good oral and written communication skills. Analyticalproblem solvingskills. Gooddecision makingskills. People management experience.Nice-to-Have
Master's degree(MA/MBA/MS)and 3+ years of experience. Doctorate (PhD/PharmD/JD). Knowledge pharmaceutical legislation in region. Good business acumen. Working knowledge of Local and International Regulatory Guidelines. Work Location Assignment: On PremiseEEO (Equal Employment Opportunity) & Employment Eligibility
Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, or disability.
Regulatory Affairs#LI-PFE