Regulatory Affairs Associate Consultant-plm

hace 3 semanas

Tlahuac, México ClinChoice A tiempo completo

Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring? Our team says it's the best of both worlds.

ClinChoice is searching for a **Regulatory Affairs Associate Consultant** to join one of our clients.

**Main Job Tasks and Responsibilities**:

- Accountable for reviewing new certificate requests and forwarding to relevant suppliers for processing
- Responsible for NDA Annual Report compilation and Drug Listing submissions to FDA
- Manages multiple tasks simultaneously to ensure performance metrics and filing deadlines are achieved according to agreed targets and BOH due dates.
- Liaise with requester where necessary to collect the information needed to submit the certificate request to the Contractor. If re-work is identified, track all rework through client systems.
- Forward request to the identified Contractor for processing, within the timeframes identified by the relevant project team.
- If required, manage legalization through Consular Services ensuring relevant administration, fees are completed and timelines adhered to.
- Communicate with requestor, Contractor or Consular Service to ensure request is processed, queries are answered and timelines are met.
- Project manage multiple requests simultaneously, ensuring filing deadlines are reached and next action dates are maintained in real time by pulling pending reports from Client's systems.
- Escalate to Client and Contractor point of contact when timelines may not be reached.
- Maintain Client systems and process throughout processing of request to ensure real time reflection of request is visible to all users.
- To seek approval from Client lead, should any certificates require fast tracking.
- Supports delivery of electronic and paper regulatory transactions and electronic review aids in support of Drug Listings, Drug Establishment Registrations, And (A) NDA Annual Report submission to FDA
- Continuous Improvement of selected processes relating to human health submissions and selected drug and non-drug specific projects and related activities e.g., Drug listing and Establishment registrations, Delivery of Product License Maintenance Portfolio in a timely and quality manner.

**Education and Experience**:

- Demonstrates ability to work within a demanding environment with a strong focus on quality and timelines.
- Can demonstrate leadership and team skills.
- Advanced Microsoft Office Suite skills.
- Highly efficient communicator.
- Acts decisively and seizes accountability
- Bachelor's degree Level (desirable or equivalent work experience.
- Familiarity with pharmaceutical organizational Structures.

**The Application Process**:
**Who will you be working for?**

**About ClinChoice**:
ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies. We have over 28 years of proven high-quality delivery and results across all our services, with over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific.

**Our Company Ethos**:
Our mission drives our culture: to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Our employees are the most valuable company asset and they are the fulcrum around which all ClinChoice activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives all personnel the clear tools needed to manage both internal and client processes with the same methodology. The success of these core values is evidenced by our below industry average turnover rates.

ClinChoice is an equal opportunity employer. We have based our success on attracting, developing, and promoting talent guided by diversity and inclusivity. Our employees come from very diverse backgrounds: gender, race, beliefs, and ethnicities. We recognize this is our strength and celebrate it.

**Key Words **:Regulatory Affairs, Regulatory Compliance, Regulatory Submission, Registrations, Product License

LI-PB1 #LI-REMOTE

  • Regulatory Affairs Associate Consultant

    hace 2 semanas

    Tlahuac, México ClinChoice A tiempo completo

    Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring? Our team says it's the best of both worlds. ClinChoice is searching for a **Regulatory Affairs Associate Consultant** to join one of our clients. **Main Job Tasks and Responsibilities**: -...

  • Regulatory Affairs Specialist

    hace 3 semanas

    Tlahuac, México Bayer A tiempo completo

    **Regulatory Affairs Specialist** **Position purpose** Act as LRA (Local RA) for all the daily activities that will ensure registrations of Radiology Medical Devices are properly done in LATAM region by submitting local dossiers, keeping country requirement table and SharePoint site folder structure updated, and ensuring the proper trackers are up to...

  • Regulatory Affairs Manager Devices

    hace 2 meses

    Tlahuac, México Artixio Consulting Pvt Ltd A tiempo completo

    **Regulatory Affairs Manager (Medical Devices) - Mexico Position** **Overview**: **Responsibilities**: - **Medical Device Registration**: - Lead the registration process for medical devices with **COFEPRIS**. - Determine the appropriate classification of devices based on the risk-based system. - Prepare and compile all necessary documentation, including...

  • Manager Regulatory Affairs Affiliate

    hace 2 semanas

    Tlahuac, México Lilly A tiempo completo

    At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities...

  • Regulatory Affairs Manager

    hace 2 semanas

    Tlahuac, México Essity A tiempo completo

    **Regulatory Affairs Manager ***: In Tork we want to shape the PH market, so we are looking for someone to provide market-relevant regulatory input for the Latam region and to build a strong base of global assortment adapted for national regulatory compliance. **About the Role**: Ensures that the assigned product assortments (from different Legal...

  • Regulatory Affairs and Policy

    hace 4 semanas

    Tlahuac, México HSBC A tiempo completo

    -Job description **Role purpose**: Regulatory Affairs deals with regulators and / or regulatory developments affecting the Bank, and in particular as they relate to Compliance risks, which include and are not limited to: - Regulatory Engagement: Delivering proactive and more consistent management and oversight of regulator relationships...

  • Global Regulatory Affairs Lcm&e

    hace 3 semanas

    Tlahuac, México Bayer A tiempo completo

    **Global Regulatory Affairs LCM&E** **Your Tasks and Responsibilities** - Responsibility for the regulatory strategy with regard to Chemistry Manufacturing and Controls (CMC) for assigned products in close cooperation with the relevant global, regional, and country RA functions, BHC Product Supply, Medical, Drug Safety and Marketing, to ensure early...

  • Global Regulatory Affairs Lcm&e

    hace 2 meses

    Tlahuac, México Bayer A tiempo completo

    **Global Regulatory Affairs LCM&E** **Your Tasks and Responsibilities** - Responsibility for the regulatory strategy with regard to Chemistry Manufacturing and Controls (CMC) for assigned products in close cooperation with the relevant global, regional, and country RA functions, BHC Product Supply, Medical, Drug Safety and Marketing, to ensure early...

  • Regulatory Affairs Manager Jr

    hace 4 semanas

    Tlahuac, México Zoetis A tiempo completo

    **Role Description** The Regulatory Affairs Manager Jr. (RAMJr.) will be responsible for executing the strategies previously defined by the RASrM, will also support the promotion of compliance, advising other Departments about local regulations (COFEPRIS, SADER and PROFECO) and global procedures. Together with the RASrM, will identify possible impacts of...

  • Regulatory Affairs Jr Specialist

    hace 1 semana

    Tlahuac, México Johnson & Johnson A tiempo completo

    Description Kenvue is currently recruiting for: **Regulatory Affairs Jr Specialist** This position reports to Latam CMC Regulatory Affairs Manager and is based at Mexico City. **Who we are** At Kenvue, we realize the extraordinary power of everyday care. Built on over a century of heritage and rooted in science, we’re the house of iconic brands -...

  • Regulatory Affairs Specialist

    hace 2 semanas

    Tlahuac, México Abbott Laboratories A tiempo completo

    **Regulatory Affairs Specialist** **Mexico City** **About Abbott** Abbott is a global healthcare leader, creating breakthrough science to improve people’s health. We’re always looking towards the future, anticipating changes in medical science and technology. **Working at Abbott** At Abbott, you can do work that matters, grow, and learn, care for...

  • Regulatory Affairs Specialist

    hace 1 semana

    Tlahuac, 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 detail...

  • Regulatory Affairs Specialist, Export Countries

    hace 2 semanas

    Tlahuac, México Solventum A tiempo completo

    **Job Description**: Regulatory Affairs Specialist, Export Countries (Solventum) Mexico City 3M Health Care is now Solventum At Solventum, we enable better, smarter, safer healthcare to improve lives. As a new company with a long legacy of creating breakthrough solutions for our customers’ toughest challenges, we pioneer game-changing innovations at the...

  • Sr Associate Regulatory Affairs

    hace 1 semana

    Tlahuac, México Amgen A tiempo completo

    **HOW MIGHT YOU DEFY IMAGINATION?**: If you feel like you’re part of something bigger, it’s because you are. At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies. We are global collaborators who achieve together—researching, manufacturing, and delivering...

  • Regulatory Affairs Analyst

    hace 6 días

    Tlahuac, México Johnson & Johnson A tiempo completo

    En **Johnson & Johnson **, la compañía de cuidado de la salud más grande del mundo, nos unimos con un propósito: transformar la historia de la salud en la humanidad. La diversidad y la inclusión son esenciales para continuar construyendo nuestra historia de pioneros e innovación, que ha estado impactando la salud de más de mil millones de pacientes y...

  • Regulatory Affairs Director

    hace 4 semanas

    Tlahuac, México GSK A tiempo completo

    **Site Name**: Mexico - Federal District - Mexico City **Posted Date**: Mar 6 2024 **_ Your 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 Senior Associate Chemistry

    hace 4 semanas

    Tlahuac, 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 Engagement Lead

    hace 5 días

    Tlahuac, México Citi A tiempo completo

    **Responsibilities**: - Responsible for providing risk strategic analytics, information management across Citibank products and reports to senior management. - Responsible for communicating to executive management implications of existing and opposed regulation and developing potential responses. This may include regulations related to specific product or...

  • Regulatory Affairs Manager

    hace 2 meses

    Tlahuac, México Capital Empresarial Horizonte A tiempo completo

    Capital Empresarial Horizonte Empresa Mexicana especialista en Recursos Humanos y Tecnologías de la Información solicita: **Regulatory Affairs Manager** Para laborar en Ciudad de México hibrido ó REMOTO en cualquier otra Ciudad. **Perfil**: Escolaridad: Ingeniería en Sistemas, Informática o afín. Experiência: Mínima de 3 años. Inglés:...

  • Regulatory Affairs Manager

    hace 2 semanas

    Tlahuac, México Capital Empresarial Horizonte A tiempo completo

    Capital Empresarial Horizonte Empresa Mexicana especialista en Recursos Humanos y Tecnologías de la Información solicita: **Regulatory Affairs Manager** Para laborar en Ciudad de México hibrido ó REMOTO en cualquier otra Ciudad. **Perfil**: Escolaridad: Ingeniería en Sistemas, Informática o afín. Experiência: Mínima de 3 años. Inglés:...