Regulatory Affairs Expert

hace 2 semanas


Ecatepec de Morelos, México Tevapharm A tiempo completo

Company Overview

Teva Pharmaceuticals is a global leader in the development and production of generic medicines, with products listed on the World Health Organization's Essential Medicines List.

We are committed to making good health more affordable and accessible to millions worldwide, through our mission to improve lives.

Job Description

We are seeking an experienced Regulatory Affairs Associate II to lead and manage all regulatory activities associated with drug development, registration, and maintenance. The ideal candidate will have strong knowledge of international regulatory requirements and be able to coordinate DMF preparation and related activities for On-Time Submissions across various markets.

Key Responsibilities

  • Support the life cycle management of APIs from a RA perspective
  • Review and approve ROS, specification, and analytical control when required
  • Coordinate pre-launch activities from a RA perspective
  • Manage the regulatory aspects and related tasks of assigned commercial APIs
  • Evaluate change requests and address submissions per market to support changes
  • Maintain up-to-date DMFs according to regulations
  • Support customers with Service Requests, providing professional information in a timely manner

Requirements

To succeed in this role, you will need:

  • Conversational English and at least 5 years of experience in RA
  • High degree in a relevant field (chemistry/biochemistry/biology or biotechnology)

Benefits

Teva Pharmaceuticals offers a competitive salary and benefits package, including:

  • A base salary of $80,000 - $110,000 per annum, depending on location and experience
  • Ongoing professional development opportunities
  • A dynamic and inclusive work environment

About Teva Pharmaceuticals

Teva Pharmaceuticals is committed to equal opportunity in employment and strives to create a diverse and inclusive workplace. If you require accommodations during the recruitment process, please advise us accordingly.



  • Ecatepec de Morelos, México Philips A tiempo completo

    Job OverviewWe are seeking an experienced Regulatory Affairs Specialist to join our team in Mexico. As a key member of the Regulatory Affairs team, you will be responsible for guiding and supporting businesses, markets, and functions on regulatory needs.


  • Ciudad de México, Ciudad de México Worldwide Clinical Trials A tiempo completo

    About the RoleWe are seeking a highly skilled Regulatory Affairs Expert to join our team at Worldwide Clinical Trials.Job DescriptionIn this role, you will be responsible for planning, initiating and tracking documents required for regulatory submissions. You will also be involved in collecting essential documents, reviewing country/site/EC requirements, and...


  • Ciudad de México, Ciudad de México ICON Plc A tiempo completo

    Senior Regulatory Affairs SpecialistWe're seeking a highly skilled Clinical Trials Regulatory Affairs Expert to join our team at ICON Plc. This is an exciting opportunity to leverage your expertise in regulatory affairs and contribute to the success of our clinical trials.About the Role:Lead the preparation, submission, and maintenance of regulatory...


  • Ciudad de México, Ciudad de México Thermo Fisher Scientific A tiempo completo

    Job DescriptionWe are seeking a highly skilled Regulatory Affairs Specialist to lead our North American team. As a key member of our regulatory affairs department, you will be responsible for ensuring compliance with local, regional, and ICH regulations. Your expertise will play a critical role in supporting product development from preclinical stages...


  • Ciudad de México, Ciudad de México Thermo Fisher Scientific A tiempo completo

    In the role of Regulatory Affairs Strategist at Thermo Fisher Scientific, you will be part of our Regulatory Liaison team, leading on communications with regulatory agencies as part of centralized regulatory submissions including but not limited to the EU CTR process. You will partner with our Regulatory Affairs leads, in providing regulatory affairs...


  • Ciudad de México, Ciudad de México Thermo Fisher Scientific A tiempo completo

    Job SummaryWe are seeking a highly skilled Sr Regulatory Affairs Specialist to join our team at Thermo Fisher Scientific. As a key member of our Regulatory Liaison team, you will play a critical role in leading communications with regulatory agencies and providing regulatory affairs strategy and technical/project leadership on a regional/global level.Key...


  • Ecatepec de Morelos, México Tevapharm A tiempo completo

    We're looking for a skilled Regulatory Affairs Specialist to join our team at Teva Pharmaceuticals. This is a unique opportunity to make a difference in the lives of millions by ensuring compliance with international regulatory requirements and driving business growth.About UsTeva Pharmaceuticals is a global leader in generic medicines, with a presence in...


  • Ciudad de México, Ciudad de México 3M A tiempo completo

    Job DescriptionWe are seeking a highly skilled Regulatory Affairs Specialist to join our team in Mexico City.OverviewAs a Regulatory Affairs Specialist, you will play a key role in coordinating regulatory strategy for the Consumer Health Group division. You will provide support and expertise as part of the Regulatory organization, using your knowledge of...


  • Ciudad de México, Ciudad de México Gilead Sciences A tiempo completo

    Gilead Sciences is seeking a highly experienced Regulatory Affairs professional to join our team in Mexico City.About GileadWe are a biopharmaceutical company dedicated to creating a healthier world by bringing life-changing therapies to people with life-threatening diseases. Our mission requires collaboration, determination, and a relentless drive to make a...


  • Ciudad de México, Ciudad de México Novartis Farmacéutica A tiempo completo

    About the Role\As a Regulatory Affairs Leader at Novartis Farmacéutica, you will play a crucial role in ensuring compliance with regulatory requirements and maintaining the technical documentation change system.\The ideal candidate will have experience managing global regulatory submission projects, providing strategic input on regulatory strategy,...


  • Ciudad de México, Ciudad de México Gilead Sciences Mexico, S. de R.L. de C.V. A tiempo completo

    At Gilead Sciences Mexico, S. de R.L. de C.V., we are seeking a seasoned Regulatory Affairs professional to join our team as a Regulatory Affairs Strategic Lead.About the RoleThis is an exciting opportunity for a highly skilled and experienced individual to play a key role in shaping our regulatory strategies and ensuring compliance with applicable...


  • Ciudad de México, Ciudad de México ICON A tiempo completo

    At ICON, we are seeking a Senior Regulatory Affairs Specialist to join our team in Mexico City.The ideal candidate will have a strong background in clinical trials and regulatory affairs, with experience in preparing and submitting regulatory documents.We offer a competitive salary of $95,000 per year, plus benefits such as annual leave entitlements, health...

  • Regulatory Affairs Lead

    hace 2 semanas


    Ciudad de México, Ciudad de México Thermo Fisher Scientific A tiempo completo

    The Regulatory Affairs Lead for North America at Thermo Fisher Scientific plays a pivotal role in ensuring compliance with local, regional, and ICH regulatory requirements. This dynamic professional provides innovative solutions to support product development from preclinical stages through registration and optimization.Key Responsibilities:Provides senior...


  • Ecatepec de Morelos, México Tevapharm A tiempo completo

    About UsTeva Pharmaceuticals is a leading manufacturer of generic medicines and proud producer of many products on the World Health Organization's Essential Medicines List. Our mission is to make good health more affordable and accessible, enabling millions worldwide to enjoy healthier lives.The OpportunityAs a Regulatory Affairs Specialist, you will lead...


  • Ciudad de México, Ciudad de México Thermo Fisher Scientific A tiempo completo

    Job Description:Senior Regulatory Affairs SpecialistThe Thermo Fisher Scientific team is seeking a highly organized and experienced Senior Regulatory Affairs Specialist to lead the development of innovative regulatory solutions and provide expertise to support product development from preclinical stages through registration and product optimization.This role...


  • Ciudad de México, Ciudad de México ICON plc A tiempo completo

    At ICON plc, we're seeking a skilled Senior Regulatory Affairs Specialist with experience in clinical trials to join our team.This role will play a pivotal part in ensuring regulatory compliance and facilitating the successful execution of clinical trials, contributing to the advancement of innovative treatments and therapies.The estimated salary for this...


  • Ciudad de México, Ciudad de México Novo Nordisk AS A tiempo completo

    Novo Nordisk A/S is seeking a skilled Regulatory Affairs Coordinator to join its GBS Mexico City team.About the RoleThe successful candidate will be responsible for supporting the compilation, submission, and approval of Country Specific Submissions files for designated countries. They will also assist affiliates in reviewing labelling materials and...


  • Naucalpan de Juárez, México Hach A tiempo completo

    At Hach, we're looking for a skilled Quality and Regulatory Affairs Coordinator to join our team. This role is responsible for providing analysis, counsel, and regulatory support to ensure high product quality and customer satisfaction.The ideal candidate will have a strong understanding of regulatory aspects of operations and be able to recommend actions...


  • Ciudad de México, Ciudad de México ICON Plc A tiempo completo

    Job SummaryWe are seeking a seasoned Regulatory Affairs Specialist to lead the preparation, submission, and maintenance of regulatory documents for clinical trials. The ideal candidate will have extensive experience in the pharmaceutical or biotech industry and possess strong knowledge of global regulatory requirements and guidelines.About the RoleDevelop...


  • Ciudad de México, Ciudad de México Cisco A tiempo completo

    Unlock a rewarding career as a wireless regulatory expert at Cisco. Salary: $150,000 - $200,000 per annum, depending on experience.About the RoleThis challenging position requires a seasoned professional with extensive knowledge of international spectrum regulation and wireless standards. As a key member of our team, you will be responsible for developing...