Regulatory Affairs Consultant

hace 4 semanas

Ciudad de México Parexel A tiempo completo

As part of Parexel Consulting, you will create and maximize value for clients throughout the product lifecycle. You will be a strategic guide in getting products to market faster, smarter - and keeping them there -your scientific, technical, regulatory, and/or commercial expertise will put best practice standards to work for biopharmaceutical and medical device companies large and small.

In return, you will be provided with interesting opportunities for growth and development and exposed to a variety of challenging assignments, product types, geographic regions, and therapeutic areas. Plus, as member of Parexel Consulting, you will enjoy all the advantages of working remotely, combined with access to the mentorship from a team of highly experienced regulatory professionals at the height of their careers. Join our team, and you will design solutions for the complexities of an ever-changing global marketplace.
- Full Time
- Travel: Yes
- Glassdoor Reviews and Company Rating

**Success Profile**:
Check out the top traits we're looking for and see if you have the right mix.
- Detail-Oriented
- Proactive
- Problem-Solver
- Results-Driven
- Organized
- Multi-Tasker

**Rewards**:

- **Global Impact**: We are one truly global team working together to propel each client´s journey ahead faster.
- **Balance**: We value work-life balance. We try and keep regular hours and an emphasis on life outside the office.
- **Freedom**: The ability to innovate, ask “what if” and try new solutions without fear of failure.
- **Variety**: Opportunities to work on multiple accounts - never boring
- **Management**: Strong management with depth of experience working for global health authorities.

**Accountability Supporting Activities**
- Works within broad project guidelines but liaises closely with more senior colleagues to discuss issues and resolve conflicts.
- Demonstrates ability to prioritize work and define steps needed to achieve specified project outcomes.
- Capitalizes on opportunities to improve one’s own performance and may provide suggestions for improving project efficiencies and results to the project technical lead.
- Seeks out information from previous projects, other client work or from colleagues to complete assigned project activities.
- May serve as a Project Lead for small scale projects or a Work Stream.
- Lead on larger projects when serving as a Project Lead.
- Responsible for project planning and set-up and routinely interacts with the assigned Project Specialist (PS) or Project Manager (PM) to appropriately control the project.
- Functions as the main client contact and ensures accurate project reporting is in place.
- Ensures that the project team delivers to meet the client expectations for quality and timeliness.
- Ensures that appropriate risk identification and issue-escalation procedures are in place.
- Ensures project specific training compliance of the project team.
- Ensures and/or manages project financials including provision of accurate revenue forecasts.
- Ensures that the project team understand and work to the scope of the contract.
- Identifies new opportunities through Change in Scope or add
- on business from existing work.
- Ensures timely project close-out activities are completed.

**Consulting Activities and Relationship Management**
- Follows and implements the organization’s consulting models and methodologies.
- Provides technical and/or business consulting services within personal area of expertise.
- Completes assigned activities within project scope and objectives with an understanding of issues which may impact project profitability.
- Collaborates with colleagues and client to identify and resolve technical and process issues.
- Leverages senior colleagues to discuss and propose resolutions to possible problems or conflicts.
- Interacts professionally at multiple levels within a client organization and within PAREXEL.
- Proactively assesses client needs and develops processes and solutions to address issues.
- Delivers assigned work and provides services and solutions which results in clients expressing satisfaction with service provided.
- Interactions result in clients expressing satisfaction with service provided.
- May prepare and/ or deliver presentation with the support of senior colleagues.
- May deliver training and mentor of junior staff.
- Identifies and alerts PC management to opportunities for follow-on business or necessary changes in project scope.

**Business Development**
- Continue to build a network of industry colleagues through relationships formed during project engagements or through other industry experience.
- Communicates potential new business leads to PC management and account managers.
- May participate in project scoping calls and/or proposal preparation with the support of senior colleagues.
- Meets established metrics as specified in scorecard on an annual basis.
- Completes basic job-related responsibilities, including timesheets, expe

  • Regulatory Affairs Specialist

    hace 4 semanas

    Ciudad de México Bayer A tiempo completo

    **Regulatory Affairs Specialist** **Major Tasks** - Provides operational support to Regulatory Affairs Management in active projects such as local regulatory strategy for New Drug Applications, local preparation for the New Molecules Committee and other projects. - Propose the local regulatory strategy for maintenance projects of the active registrations by...

  • Regulatory Affairs Analyst

    hace 4 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...

  • Regulatory Affairs Specialist

    hace 4 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...

  • Senior Manager, Regulatory Affairs

    hace 1 mes

    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 Manager

    hace 16 horas

    Ciudad de México HSBC A tiempo completo

    If you’re looking for a career where you can make a real impression, join our Global Service Center - HSBC and discover how valued you’ll be. We are currently seeking an experienced professional to join our team in the role of Regulatory Affairs Manager Role Purpose: Regulatory Affairs Team supports the Compliance Function on a Global level,...

  • Regulatory Affairs Specialist

    hace 4 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...

  • Regulatory Affairs Officer

    hace 1 mes

    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 1 mes

    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...

  • 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...

  • LATAM Government Affairs Manager

    hace 3 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...

  • Senior Manager Public Affairs and Policy

    hace 1 mes

    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,...

  • Intern, Regulatory Affairs, 2024

    hace 6 días

    Ciudad de México GSK A tiempo completo

    Nome della sede: Mexico City Torre MitikahData di apertura: May 13 2024Intern,Regulatory Affairs, 2024Modelo híbrido: mínimo 2 días en el sitio por semanaAyúdanos a adelantarnos a la enfermedad junto con nuestra  Área de Asuntos Regulatorios Formación requerida: Estudiante activo Químico farmacobiólogo, ingeniero farmacéutico, ingeniería química,...

  • Intern, Regulatory Affairs, 2024

    hace 6 días

    Ciudad de México, Ciudad de México GSK A tiempo completo

    Nome della sede: Mexico City Torre MitikahData di apertura: May Intern,Regulatory Affairs, 2024Modelo híbrido: mínimo 2 días en el sitio por semanaAyúdanos a adelantarnos a la enfermedad junto con nuestra Área de Asuntos Regulatorios Formación requerida: Estudiante activo Químico farmacobiólogo, ingeniero farmacéutico, ingeniería química,...

  • Specialist, Regulatory Affairs

    hace 4 días

    México Worldwide Clinical Trials A tiempo completo

    **Requisition Number**7930** **Employment Type**:Regular** **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...

  • Intern, Regulatory Affairs, 2024

    hace 5 días

    Ciudad de México GlaxoSmithKline A tiempo completo

    Site Name: Mexico City Torre Mitikah Posted Date: May 13 2024 Intern,Regulatory Affairs, 2024 Modelo híbrido: mínimo 2 días en el sitio por semana Ayúdanos a adelantarnos a la enfermedad junto con nuestra Área de Asuntos Regulatorios Formación requerida: Estudiante activo Químico farmacobiólogo, ingeniero farmacéutico, ingeniería...

  • Regulatory Affairs Intern

    hace 4 semanas

    Ciudad de México The Estée Lauder Companies A tiempo completo

    . **Qualifications** **Job**: Environmental Health & Safety - Supply Chain **Primary Location**: Latin America-MX-CMX - **Job Type**: Standard **Schedule**: Part-time **Shift**: 1st (Day) Shift **Job Number**: 2223555 We welcome people with all types of disabilities.

  • External Affairs Manager

    hace 1 mes

    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...

  • 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...

  • Scientist Engineer I

    hace 3 semanas

    Estado de México Mondelez International A tiempo completo

    Are You Ready to Make It Happen at Mondelēz International? Join our Mission to Lead the Future of Snacking. Make It With Pride. You execute the scientific and regulatory affairs strategy for your respective category or categories and geographical area using your scientific and regulatory expertise and are responsible for the regulatory and policy...

  • Market Risk Consultant

    hace 1 mes

    Ciudad de México Mirai A tiempo completo

    Mirai Advisory is a global consulting firm which is focused on Asset & Liability Management. We are committed to providing a strong value-added solution and excellent services our clients. Our people are driven, motivated, and strive to meet rigorous objectives. Having a multidisciplinary team is essential to our success. We are looking for a proactive...