Senior Manager, Regulatory Affairs

Encontrado en: Jooble MX O C2 - hace 3 semanas

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 global team of almost 3,000 experts, bright thinkers, dreamers and doers and, together, we are changing the way the world experiences CROs – in the best possible way.

Our mission is to work with passion and purpose every day to improve lives and we are looking for others who value this same pursuit.

In this role, The Manager, Regulatory Affairs provides project representation and input to projects awarded for all stages of the drug development cycle and ensures the smooth running of the Regulatory Affairs Department.

What you will do

  • Review study budgets and costing pertaining to contract negotiation, participate in business development activities, prepare regulatory sections of proposals and feasibility reports and attend bid defense meetings to meet business needs
  • Coordinate & manage regulatory & ethics committee submissions and maintain approvals throughout EMEA, Asia Pacific and Latin America regions and ensure accurate compilation, management and tracking of submissions
  • Provide expert regulatory advice and contribute to regulatory project work. Effectively communicate status of submissions with the Sponsor, Project Manager, CRAs, Medical & Scientific Affairs staff. Contribute towards the preparation of technical documentation such as IMPDs and IBs, review and make recommendations on all relevant documentation to ensure compliance with ICH GCP & country specific requirements
  • Provide training, coaching and mentoring to junior members of staff, may be required to line manage junior members of staff

What you will bring to the role

  • Clearly, proven leadership and organizational management skills are essential attributes
  • Strong planning, strategizing, managing, monitoring, scheduling, and critiquing skills
  • Excellent written and verbal communication skills to clearly and concisely present information
  • Relationship-building competency combined with demonstrated comfort supporting Business Development at face-to-face meeting
  • Strong interpersonal skills in a fast-paced, deadline oriented, and changing environment
  • Excellent ability to handle multiple tasks in a fast-paced and constantly changing environment

Your experience

  • Bachelor's Degree in Chemistry or Life Sciences, Nursing or equivalent experience
  • Previous experience within the pharmaceutical/CRO industry working as a Senior Regulatory Affairs Specialist with some CRO experience

Why Worldwide
At Worldwide, we balance fun with the serious business of changing lives. We have a values-driven culture that is built from the ground up. We empower our team members to treat every clinical trial like a patient’s life depends on it – because it does.Our leaders are in the trenches with you - committed to advancing science and moving mountains for our customers.

Interested in hearing more about Worldwide or our roles? Check out our careers page at

#J-18808-Ljbffr

  • Senior Regulatory Affairs Manager

    hace 6 días

    Edo. de México Artixio Consulting Pvt Ltd A tiempo completo

    Artixio is a global regulatory and quality services company with offices in USA, Germany, UAE, India and affiliates in about 70 countries. As next leap of our growth, we plan to expand our presence in Mexico. We are inviting Regulatory Affairs Leaders to join our regional team. We are seeking entrepreneurial professionals who wish to be part of the...

  • Manager, Regulatory Affairs

    hace 5 días

    Ciudad de México Biogen A tiempo completo

    **Job Description**: **About This Role** Reporting to the Sr. Manager, Regulatory affairs, the Manager supports all regulatory strategies creating tactics for new products at local and global levels. **What you will do**: - Responsible for precise and aligned communication with local teams and global Regulatory team. - Coordinate all post-registration...

  • Regulatory Affairs Manager

    Encontrado en: Jooble MX O C2 - hace 3 semanas

    México Unilever A tiempo completo

    Regulatory Affairs Manager page is loaded Regulatory Affairs Manager Solicitar locations Col. Bosques de las Lomas, Mexico time type Tiempo Completo posted on Publicado hace 7 días job requisition id R-86602 Full/Part Time: Full Time Location: Mexico, Brazil Business Context Established in 2018, Unilever’s US-centric Health & Wellbeing business is...

  • Regulatory Affairs Manager

    Encontrado en: Jooble MX O C2 - hace 3 semanas

    Ciudad de México Unilever Brazil A tiempo completo

    Full/Part Time: Full Time Location: Mexico, Brazil Business Context Established in 2018, Unilever’s US-centric Health & Wellbeing business is a collective of fast-growing, science-backed companies powering a lifestyle of wellbeing designed for a lifetime of possibilities. Comprised of Liquid I.V., Nutrafol, OLLY, Onnit, SmartyPants, Welly and Equilibra...

  • Regulatory Affairs Specialist

    Encontrado en: Jooble MX O C2 - hace 2 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...

  • Head of Regulatory Affairs and QA

    hace 5 días

    Ciudad de México IPSEN A tiempo completo

    **Title**: Head of Regulatory Affairs and QA (Mexico & Export markets) **Company**: Ipsen Mexico S de RL de CV Head of Regulatory Affairs and QA (Mexico & Export markets)

  • Regulatory Reporting Senior Manager

    Encontrado en: Jooble MX O C2 - hace 3 días

    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 (GSC)- HSBC and discover how valued you’ll be. We are currently seeking an experienced professional to join our team in the role of Regulatory Reporting Senior Manager Role purpose: The Regulatory Reporting Manager is responsibility is for reviewing,...

  • Regulatory Affairs Analyst

    Encontrado en: Jooble MX O C2 - hace 2 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...

  • LATAM Government Affairs Manager

    Encontrado en: Jooble MX O C2 - hace 6 días

    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...

  • Regulatory Affairs Manager

    Encontrado en: Talent MX C2 - hace 3 semanas

    Ciudad de México Unilever A tiempo completo

    Description : The successful candidate will co-ordinate the know-how and roll-out of VMS products in South America. Working together with internal or external stakeholders, the candidate will be responsible for the following activities. Driving detailed business understanding on the different product notification/registration requirements for VMS in...

  • Regulatory Affairs Specialist

    Encontrado en: Jooble MX O C2 - hace 2 semanas

    Ciudad de México Edwards Lifesciences Gruppe A tiempo completo

    We have made changes to enhance your experience. If you have applied for a job previously, you will need to create a new account. Thank you for your patience. Regulatory Affairs Specialist (temporary position) page is loaded Regulatory Affairs Specialist (temporary position) Apply locations Mexico-Mexico City time type Full time posted on Posted 4 Days Ago...

  • External Affairs Manager

    Encontrado en: Jooble MX O C2 - hace 2 semanas

    México Bacardi-Martini A tiempo completo

    Key Accountabilities and Responsibilities Together with local management and the Legal and External Affairs Director LAC, coordinate the activities of the Company's Department of External Affairs, develop and implement a common long-term strategy. On behalf of the Company, provide constructive interaction with groups of influence (government bodies,...

  • Regulatory Affairs Specialist

    Encontrado en: Jooble MX O C2 - hace 2 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 Science Analyst

    hace 1 día

    Ciudad de México Pfizer A tiempo completo

    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...

  • Regulatory Manager

    hace 7 días

    Ciudad de México Upfield A tiempo completo

    **Regulatory & Nutrition Manager** **México** ¡Nuestro equipo de R&D está en búsqueda de talento! En esta posición coordinarás, verificarás y asegurarás el cumplimiento y seguimiento de los asuntos regulatorio con las diferentes autoridades sanitarias de Latinoamérica, estableciendo y ejecutando las estrategias más adecuadas para el sometimiento...

  • Regulatory Affairs Director

    Encontrado en: beBee S MX - hace 4 semanas

    Ciudad de México GSK A tiempo completo

    Site Name: Mexico - Federal District - Mexico CityPosted Date: Mar 6 2024Your Responsibilities: Are you looking for an opportunity for Strategic planning and execution for obtaining the approval of Vaccines, Pharmaceutical and ViiV pipeline, as well as for new projects? If so, this is the role for you. YOU will need the ability to Develop regulatory...

  • Regulatory Affairs Specialist III

    Encontrado en: beBee S MX - hace 7 días

    Ciudad de México Thermo Fisher Scientific A tiempo completo

    Location Mexico City, Mexico Job Id R-01227994 Prepares, reviews and coordinates, under guidance and local EC submissions in. Supports preparation, under guidance, of local...

  • Trainee, Regulatory Affairs, 2024

    Encontrado en: beBee S MX - hace 4 semanas

    Ciudad de México GSK A tiempo completo

    Nama Site: Mexico City Torre MitikahTanggal Posting: Mar 5 2024Regulatory Affairs, Trainee, 2024Modelo híbrido: 2 días en el sitio por semanaAyúdanos a adelantarnos a la enfermedad junto con nuestra  Área de Regulatory Affairs Formación requerida: Egresado de Químico farmacobiólogo, ingeniero farmacéutico o afines.Otros requisitos:Disponibilidad de...

  • Regulatory Sciences Strategist Cta Analyst

    hace 4 días

    Ciudad de México Pfizer A tiempo completo

    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...

  • Trainee, Regulatory Affairs, 2024

    Encontrado en: beBee S MX - hace 4 semanas

    Ciudad de México GSK A tiempo completo

    Pobočka: Mexico City Torre MitikahDatum zveřejnění: Mar 5 2024Regulatory Affairs, Trainee, 2024Modelo híbrido: 2 días en el sitio por semanaAyúdanos a adelantarnos a la enfermedad junto con nuestra  Área de Regulatory Affairs Formación requerida: Egresado de Químico farmacobiólogo, ingeniero farmacéutico o afines.Otros requisitos:Disponibilidad...