Regulatory Affairs Jr. Manager
hace 1 semana
**Company Description**
The mission of the Regulatory Affairs Manager is to lead the activities to register and maintain registration of oncology and specialty care products in Chile, cooperating with the Regional Manager, in alignment with business needs, to assure compliance with local regulations and with AbbVie policies.
The Technical Director is AbbVie’ representative before the regulatory authorities in Chile, the link between the company and the regulators, with responsibility over all the pharmaceutical products and the medical products in the AbbVie’s portfolio. The Technical Director is the Agency Point of Contact for Clinical Studies and is also the representative at the Trade Association. It is a mandatory function to operate in the country.
**_ Main Responsibilities_**
Regulatory Strategies for Oncology & Specialty Care Products in Chile:
- Lead the definition of regulatory strategies for oncology and specialty care products in Chile.
- Keep Area informed on country strategies and requirements.
- Active participation in Brand Teams and other strategic meetings to stay focused in Business needs.
Licenses for Oncology & Specialty Care Products in Chile:
- Manage the registration of oncology & specialty care products, modifications, and renewals, in agreement with the local regulatory framework.
Registries for Oncology & Specialty Care Products in Chile:
- Actively manage the registration of oncology & specialty care products, modifications, and renewals, in agreement with the local regulatory framework. Interact with the Health Authority of Chile, negotiating strategies and acceleration of revisions.
Business Support:
- Support commercial, medical and market access areas during product launches and associated promotional activities, providing robust regulatory strategies. Participate in Brand Team meetings, as required.
- Support business initiatives and the Ethics and Compliance program, efficiently communicating the regulatory perspective.
Trade Associations:
- Actively participate in Trade Association meetings, advocating to achieve AbbVie’s desired position.
Technical Director Responsibilities.
- Act as AbbVie’s technical referent and legally bound responsible before the Regulatory Body. The technical director is legally liable in solidarity with the company, using her or his signature to back up not only the filings but also the importation of products and the release of such products to the internal market.
- Support audits to AbbVie or third parties or attend meetings required by the MoH, as deputy technical responsible.
- Responsibility over pharmaceutical products and medical devices resulting from the integration of AbbVie’s and Allergan’s portfolios.
Others:
- Collaboration in the implementation of programs from the area in the affiliates
- Support and generate initiatives to disseminate knowledge of the regulatory area to other areas of the company.
**Qualifications**
**_
Training, Education and Experience_**
- Pharmacist
- 10 years of experience in Regulatory Affairs / Pharmaceutical Industry.
- Strong knowledge of applicable regulations and regulatory strategies.
- English: Advanced Level (FCE).
- Negotiation skills.
- Good communication skills.
- Proactive attitude.
- Skills for teamwork.
**Additional Information**
US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:
-
Regulatory Affairs Manager
hace 2 semanas
Santiago de Chile Artixio Consulting Pvt Ltd A tiempo completo**Company Description** ArtiXio is a global consulting and services company specializing in Regulatory Affairs, Market Access, and Pharmacovigilance for pharmaceutical, biotech, cosmetics, medical device, and dietary supplements manufacturers. Our services cover compliance, regulatory intelligence in over 70 countries, regulatory operations, post-market...
-
Regulatory Affairs Country Lead
hace 7 meses
Santiago de Chile Johnson & Johnson A tiempo completoDiversity, Equity & Inclusion are essential to continue building our history of pioneering and innovation, which has been impacting the health of more than 1 billion patients and consumers every day for more than 130 years. Regardless of your race, belief, sexual orientation, religion, or any other trait, YOU are welcome in all open positions at the largest...
-
Regulatory Affairs Specialist
hace 2 meses
Santiago de Chile Solventum A tiempo completoJob Description: Regulatory Affairs Specialist, Chile (Export) (Solventum) 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 intersection of...
-
Regulatory Affairs Specialist
hace 2 días
Santiago, Metropolitana, Chile Allergan A tiempo completoAt Allergan, we strive to have a remarkable impact on people's lives across various key therapeutic areas – immunology, oncology, neuroscience, and eye care.Company OverviewOur mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow.We are committed to...
-
Regulatory Affairs Specialist
hace 4 semanas
Santiago, Metropolitana, Chile Pfizer A tiempo completoJob SummaryWe are seeking a skilled Regulatory Affairs Specialist to join our team at Pfizer.This role will support the Regulatory team in new product registration and post-approval changes, working closely with local and regional stakeholders to deliver efficient regulatory submissions and processes.The successful candidate will possess a thorough...
-
Project Director
hace 1 mes
Santiago, Metropolitana, Chile ENGINEERINGUK A tiempo completoLead Regulatory Affairs SpecialistWe are seeking an experienced Project Director to lead our Regulatory Affairs team in Colombia and Chile. As a key member of our Language Services department, you will play a critical role in expanding our business growth through Regulatory Labelling authorization services.Job SummaryThe successful candidate will have a...
-
Regulatory Affairs Analyst
hace 7 meses
Santiago de Chile Novartis A tiempo completo387432BR **Regulatory Affairs Analyst**: Chile **About the role** 1.066.824. That’s the number of patients we reached in 2021. We want curious, courageous and collaborative people like you to join our inspiring environment. Here you’re given opportunities to make a genuine impact on our patient driven mission. Here you’re surrounded by people who...
-
Highly Experienced Senior Project Manager
hace 1 mes
Santiago, Metropolitana, Chile ICON A tiempo completoSenior Project Manager Job DescriptionThe ideal candidate will have a proven track record of success in managing complex projects and teams, with a strong background in regulatory affairs labelling.We are seeking a highly experienced Senior Project Manager to join our team in Colombia and Chile. As a Senior Project Manager, you will play a key role in...
-
Regulatory Affairs Jr. Manager
hace 6 horas
Santiago, Chile Allergan A tiempo completoCompany Description AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products...
-
Regulatory Affairs Specialist
hace 7 meses
Santiago de Chile BAXTER A tiempo completo**This is where you save and sustain lives** At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You'll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients. Baxter's products and therapies are found in...
-
Allergan | Regulatory Affairs Jr. Manager
hace 2 días
santiago, Chile Allergan A tiempo completoCompany DescriptionAbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services...
-
Regulatory Affairs Analyst
hace 7 meses
Santiago de Chile Novo Nordisk A tiempo completoCan you drive the global strategy for culture, engagement and performance management at Novo Nordisk? Do you have the interpersonal skills to navigate in a complex stakeholder landscape and are you able to motivate, set direction and deliver results? At Novo Nordisk, we are our people. And together we can make an impact. **The Position** **Main...
-
Regulatory Affairs Specialist
hace 1 mes
Santiago, Chile Solventum A tiempo completoGracias por tu interés en trabajar para nuestra empresa. Contar con el talento adecuado es crucial para lograr nuestros objetivos. El 01 de abril de 2024, 3M Healthcare experimentó una separación corporativa que condujo a la creación de una nueva empresa denominada Solventum. Aún, estamos en el proceso de actualizar nuestra página de carreras y los...
-
Strategic Project Manager
hace 1 mes
Santiago, Metropolitana, Chile ENGINEERINGUK A tiempo completoSenior Project Manager OpportunityWe are seeking an experienced Senior Project Manager to join our team at ICON, a world-leading healthcare intelligence and clinical research organization.As a Senior Project Manager, you will play a crucial role in expanding our business growth within the Language Services team through Regulatory Labelling authorization...
-
Regulatory Affairs Specialist, Export Countries
hace 7 meses
Santiago de Chile Solventum A tiempo completo**Job Description**: Regulatory Affairs Specialist, Export Countries (Solventum) - Chile or Colombia- 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...
-
Project Director for Regulatory Affairs
hace 1 mes
Santiago, Metropolitana, Chile ICON A tiempo completoAbout ICONICON plc is a world-leading healthcare intelligence and clinical research organization. We pride ourselves on fostering an inclusive environment that drives innovation and excellence, and we welcome talented individuals to join us in shaping the future of clinical development.Our company's success depends on the quality of our people, which is why...
-
Santiago, Metropolitana, Chile Artixio Consulting Pvt Ltd A tiempo completoAbout Artixio Consulting Pvt LtdWe are a global consulting and services company specializing in Regulatory Affairs, Market Access, and Pharmacovigilance for pharmaceutical, biotech, cosmetics, medical device, and dietary supplements manufacturers. Our services cover compliance, regulatory intelligence in over 70 countries, regulatory operations, post-market...
-
Regulatory Affairs Specialist Chile
hace 1 mes
Santiago, Metropolitana, Chile Guerbet A tiempo completoAt Guerbet, we build lasting relationships to enable people to live better. This is Our Purpose.We are a global leader in medical imaging, offering an extensive portfolio of pharmaceuticals, medical devices, digital and AI solutions, for diagnostic and interventional imaging.As a pioneer in the field of contrast products since 95 years, we continuously...
-
Regulatory Science Analyst
hace 1 mes
Santiago de Chile Pfizer A tiempo completoJOB SUMMARY - Support the Regulatory team in the activities associated to new product registration and post approval changes during product lifecycle for the assigned portfolio - Work in collaboration across the Cluster / Country (as applicable) to deliver efficiencies in regulatory submissions and processes. - Interact with local Regulatory Teams, Regional...
-
Senior Manager, Corporate Affairs
hace 4 meses
Santiago de Chile Novartis A tiempo completo**Summary**: We are seeking a Senior Manager of Corporate Affairs who will be responsible to lead and support Public Affairs activities/projects to support business objectives, engage stakeholders, shape external policy in the area of responsibility. This position will be responsible to position Novartis as a trusted partner and hold key external stakeholder...