Empleos actuales relacionados con Regulatory Affairs Analyst - Americas MX México CSL Behring - CSL Behring

  • Regulatory Affairs Specialist

    hace 2 meses

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

    Regulatory Affairs SpecialistThermo Fisher Scientific is seeking a highly skilled Regulatory Affairs Specialist to join our Regulatory Liaison team. As a key member of our team, you will be responsible for leading communications with regulatory agencies and providing regulatory affairs strategy and technical/project leadership on a regional/global level.Key...

  • Regulatory Affairs Specialist

    hace 6 días

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

    In this role as a Regulatory Affairs Specialist, you will be part of our Regulatory Liaison team, leading on communications with regulatory agencies as part of centralized regulatory submissions. You will partner with our Regulatory Affairs leads, in providing regulatory affairs strategy and technical/project leadership on a regional/global level.Key...

  • Regulatory Affairs Expert

    hace 3 días

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

    In this role as a Regulatory Affairs Expert, you will be part of our Regulatory Liaison team, leading on communications with regulatory agencies as part of centralized regulatory submissions. You will partner with our Regulatory Affairs leads, in providing regulatory affairs strategy and technical/project leadership on a regional/global level.Key...

  • Regulatory Affairs Specialist

    hace 1 mes

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

    Regulatory Affairs SpecialistThermo Fisher Scientific is seeking a highly skilled Regulatory Affairs Specialist to join our team. 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...

  • Regulatory Affairs Specialist

    hace 3 semanas

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

    Regulatory Affairs SpecialistThermo Fisher Scientific is seeking a highly skilled Regulatory Affairs Specialist to join our Regulatory Liaison team. As a key member of our team, you will be responsible for leading on communications with regulatory agencies as part of centralized regulatory submissions, including the EU CTR process.Key...

  • Regulatory Affairs Specialist

    hace 4 semanas

    Ciudad de México, Ciudad de México ProductLife Group A tiempo completo

    Regulatory Affairs Officer Job DescriptionWe are seeking a highly skilled Regulatory Affairs Officer to join our team at ProductLife Group. As a key member of our regulatory team, you will be responsible for ensuring the delivery of regulatory activities on a global level.Responsibilities:Contribute to the production of client administrative documents for...

  • Regulatory Affairs Specialist

    hace 3 días

    Ciudad de México, Ciudad de México ProductLife Group A tiempo completo

    We are seeking a Regulatory Affairs Specialist to contribute to ensuring the delivery of regulatory activities on a global level.Key Responsibilities:To assist in the production of client administrative documents for regulatory submissions.To compile regulatory dossiers in accordance with national requirements and ensure their accuracy.To manage systems and...

  • Regulatory Affairs Specialist

    hace 4 semanas

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

    Position for Novo Nordisk GBS MexicoWe are seeking a highly skilled Regulatory Affairs Coordinator to join our team in GBS Mexico City. As a key member of our global business service centre, you will play a critical role in ensuring compliance with regulatory standards and supporting our global operations.The RoleAs a Regulatory Affairs Coordinator, you will...

  • Regulatory Affairs Specialist

    hace 2 semanas

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

    Position for Novo Nordisk GBS MexicoWe are seeking a highly skilled Regulatory Affairs Coordinator to join our team in GBS Mexico City. As a key member of our team, you will play a crucial role in ensuring compliance with regulatory standards and supporting our global operations.The RoleAs a Regulatory Affairs Coordinator, you will be responsible...

  • Regulatory Affairs Specialist

    hace 2 meses

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

    **Job Summary**Thermo Fisher Scientific is seeking a highly skilled Regulatory Affairs Specialist to join our team. As a key member of our Regulatory Liaison team, you will be responsible for leading on communications with regulatory agencies as part of centralized regulatory submissions.**Key Responsibilities**Provide regulatory advice and carry out...

  • Regulatory Affairs Manager

    hace 2 semanas

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

    Job Title: Regulatory 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. in Mexico City. As a key member of our Regulatory Affairs team, you will be responsible for developing and implementing regulatory strategies to ensure compliance with applicable regulations and...

  • Regulatory Affairs Specialist

    hace 7 días

    Ciudad de México, Ciudad de México ProductLife Group A tiempo completo

    Regulatory Affairs SpecialistWe are seeking a highly skilled Regulatory Affairs Specialist to join our team at ProductLife Group. As a Regulatory Affairs Specialist, you will be responsible for managing post-approval activities for the Canadian market, including life cycle management, change controls, and regulatory submissions.Key Responsibilities:Manage...

  • Regulatory Affairs Specialist

    hace 2 semanas

    Ciudad de México, Ciudad de México ProductLife Group A tiempo completo

    Regulatory Affairs Officer Job DescriptionWe are seeking a highly skilled Regulatory Affairs Officer to join our team at ProductLife Group. As a key member of our regulatory team, you will be responsible for ensuring the delivery of regulatory activities on a global level.Key Responsibilities:Contribute to the production of client administrative documents...

  • Regulatory Affairs Specialist

    hace 4 semanas

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

    Position for Novo Nordisk GBS MexicoWe are seeking a highly skilled Regulatory Affairs Coordinator to join our team in GBS Mexico City. As a key member of our team, you will be responsible for supporting the compilation, submission, and approval of Country Specific Submissions files for responsible countries.The RoleProvide regulatory support to affiliates...

  • Regulatory Affairs Specialist

    hace 1 mes

    Ciudad de México, Ciudad de México ProductLife Group A tiempo completo

    Regulatory Affairs OfficerProductLife Group is seeking a highly skilled Regulatory Affairs Officer to manage post-MAA activities for the Canadian market.ResponsibilitiesManage post-approval activities (Life Cycle Management) for the Canadian market, ensuring compliance with Health Canada guidelines.Initiate change controls, including regulatory assessments...

  • Regulatory Affairs Professional

    hace 3 días

    Ciudad de México, Ciudad de México Icon Plc A tiempo completo

    The Regulatory Affairs Specialist will contribute to the preparation, compilation, and submission of regulatory documents, including CT/IND, MAA, and NOA. Key Responsibilities:- Regulatory Document Preparation: Prepare and submit regulatory documents in a timely and accurate manner.- Collaboration with Teams: Work with the Regulatory Submissions team and...

  • Regulatory Affairs Specialist

    hace 1 semana

    Ciudad de México, Ciudad de México Mccormick & Company A tiempo completo

    **Scientific and Regulatory Affairs Manager LATAM**Mccormick & Company, a world leader in the spice, flavor and seasonings industry, is seeking a full time Scientific and Regulatory Affairs Manager LATAM. This new hire will work in our Mexico City location.We create differentiating flavors consumers prefer with unmatched quality, science, innovation and...

  • Regulatory Affairs Specialist

    hace 1 mes

    Ciudad de México, Ciudad de México ProductLife Group A tiempo completo

    Regulatory Affairs Officer Job DescriptionWe are seeking a highly skilled Regulatory Affairs Officer to join our team at ProductLife Group. As a key member of our regulatory team, you will be responsible for ensuring the delivery of regulatory activities on a global level.Responsibilities:Contribute to the production of client administrative documents for...

  • Regulatory Affairs Specialist

    hace 3 semanas

    Ciudad de México, Ciudad de México ProductLife Group A tiempo completo

    Regulatory Affairs Officer Job DescriptionWe are seeking a highly skilled Regulatory Affairs Officer to join our team at ProductLife Group. As a key member of our regulatory team, you will be responsible for ensuring the delivery of regulatory activities on a global level.Responsibilities:Contribute to the production of client administrative documents for...

  • Regulatory Affairs Manager

    hace 7 días

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

    Job Title: Regulatory Affairs ManagerWe are seeking a highly skilled Regulatory Affairs Manager to join our team at Gilead Sciences. 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 Analyst

hace 2 meses

Americas MX México CSL Behring CSL Behring A tiempo completo
The Opportunity:

Reporting to the Sr. Manager, Operations, Group of Latin American Distributors (GLAD), as the Regulatory Affairs Analyst, you will support the Regional Regulatory group with review of documentation for NDAs, renewals, dispatch of variations, and invoice management. You will be the contact for distributors/regulatory agents of the assigned region. You will be responsible for registrations and the effective regulatory lifecycle management of CSL Behring’s products in the distributor markets in the assigned region. You will work in close collaboration with the regulatory affairs managers of the distributors (customer) and at the manufacturing sites (internal). This is a hybrid role, which offers a combination of onsite and remote work.

The Role:

Assigned Countries of regulatory responsibilities (all sites, all products)

  • Mixed group of countries in Central America, South America, and the Caribbean, COMISCA (Council of Ministers of Health of Central America), PAHO (Pan American Health Organization).

Regulatory Coordination for the assigned countries

Interface between distributors/regulatory agents (3rd parties), Global Regulatory Affairs and Commercial Operations Intercontinental for the assigned region:

  • Ensure that the distributor/regulatory agents follow CSL standards and guidelines to accomplish any regulatory activities. Is the primary contact for all distributors/agents and provide first line replies.
  • Responsible for optimal product compliance with approved regulatory status by supervising the regulatory activities.
  • Responsible to obtain marketing authorizations according registration plan.
  • Responsible to maintain the marketing authorizations: prepare and support applications, variations license maintenance, labelling and renewals documents according to local requirements and in close collaboration with Global Regulatory Affairs.
  • Effective planning, coordination, tracking and communication of local requirements/regulations and submission deadlines to stakeholders.
  • Provide and maintain overview on pending and planned activities and manage prioritisation and new objectives.

Tender Operation Activities for the assigned countries

  • Support tender submissions (bidding process, fulfilment) in close collaboration with Sales Managers and Supply Chain.
  • Responsible for tenders’ complete regulatory compliance control (from tender announcement through product dispatch to the distribution market).

Team support activities for GLAD

  • Review local dossier for NDA and renewal.
  • Variation handling of all appropriate markets:
    • Uploading to SharePoint / distribution to countries as required and any other platform required.
    • Supervision of tracking / reporting as required.
  • Support of any upcoming project of the team (under supervision of the responsible team member).
  • Invoice management.
  • Coordinates and supports regulatory compliance in GLAD.

Strategy

  • Ensure strategies are aligned within Commercial Operations and follow priorities as communicated by the supervisor.
  • Contribute to strategic CSL Behring projects as project manager or team member, as required.

Customer Relations

  • Ensure appropriate, relevant, and timely training of distributors/regulatory agents on adherence to all applicable CSL Behring policies/ procedures and guidelines.
  • Ensure and organize, in collaboration with the supervisor that Registration Agreements and/or Confidential Agreements are in place with distributors/regulatory agents for the assigned region.
  • Facilitate mutual understanding and solution finding of country specific matters versus CSL Behring global interests.
  • Timely communication of upcoming audits and trainings.

Reporting & Communication

  • Weekly oral management reporting of key issues (Jour Fix).
  • Consolidated written monthly report on key issues and progress.
  • Active participation in team meetings, trainings, and workshops.

Your Skills and Experience:
  • Minimum Bachelor’s degree in life-sciences (pharmacy).
  • 1 - 2 years of work experience strongly preferred.
  • Excellent verbal and written communication and presentation skills in English language and Spanish.
  • Target and performance oriented, ability to work systematically, structured and under pressure.
  • Good planification and self-management.
  • Strong interpersonal and communication skills.
  • Able to work and communicate effectively and collaboratively across Affiliate functions, the GCSP organization and other global CSL functions.
  • Ability to establish and maintain good working relationships with internal and external stakeholders.

Our Benefits

We encourage you to make your well-being a priority. It’s important and so are you. Learn more about how we care at CSL.

About CSL Behring

CSL Behring is a global leader in developing and delivering high-quality medicines that treat people with rare and serious diseases. Our treatments offer promise for people in more than 100 countries living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. Learn more about CSL Behring.

We want CSL to reflect the world around us

As a global organization with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion at CSL.

Do work that matters at CSL Behring