Regulatory Affairs Specialist
Encontrado en: Jooble MX O C2 - hace 2 semanas
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 products), post licensing regulatory submissions.
- Contribute to the production of client administrative documents to be included in regulatory submissions
- Compile regulatory dossiers in accordance with national requirements.
- Systems Management and Administration
- Document and track regulatory submissions and regulatory authority approval.
- Provide regulatory support to clients and associate companies
- Liaise with sponsor head-office and affiliate departments on regulatory issues.
- Provide review of packaging texts.
- Provide format review of Summary of Product Characteristics, Patient Information Leaflets, and labelling (e.g., QRD compliance check).
- Contribute to data entry in PLG tools enabling measurements of KPI, metrics for regulatory services
- Bachelor’s degree or more in a Life Sciences related field. Pharmacy degree would be a plus.
- 5+ years of experience in Regulatory Affairs in the Pharmaceutical Industry or via a Service Provider
Hard/Technical skills:
- Experience in regulatory lifecycle maintenance activities for drug products (Renewals, PI updates, technical variations) in LATAM
- Knowledge of MX and LATAM (Guatemala, Panama, Dominican Republic) regulations for pharmaceuticals (NCE, Biologicals and Biotech), Medical Devices, Combination products
- Good understanding of data and document management systems, MS Office applications
- New registrations of drug products is preferable.
- Excellent organizational and interpersonal skills
- Ability to work well within a team and autonomously
- Ability to prioritize different workloads/multi-task
- Ability to deliver on tight timelines
- Process orientated with good attention to detail
-
Regulatory Affairs Qro
hace 11 horas
México Tata Consultancy Services A tiempo completoWe are a multinational company in the technology consulting and services field, with presence in 46 countries and more than 600,000 employees. Our company is looking for an **Regulatory Affairs**, Functions to join the team: Required Experience: - **COMPLETE YOUR APPLICATION THAT WILL BE SENT BY MESSEGE ON INDEED**: - Regulatory advice to drug development...
-
Senior Manager, Regulatory Affairs
Encontrado en: Jooble MX O C2 - hace 3 semanas
México Worldwide Clinical Trials, LLC A tiempo completoWho 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...
-
Head of Regulatory Affairs and QA
hace 6 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 Affairs Manager
Encontrado en: Jooble MX O C2 - hace 3 semanas
México Unilever A tiempo completoRegulatory 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 Specialist
Encontrado en: Jooble MX O C2 - hace 2 semanas
Ciudad de México Edwards Lifesciences A tiempo completoMake 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 Analyst
Encontrado en: Jooble MX O C2 - hace 2 semanas
Ciudad de México Viatris A tiempo completoRegulatory 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...
-
Manager, Regulatory Affairs
hace 6 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...
-
Senior Regulatory Affairs Manager
hace 7 días
Edo. de México Artixio Consulting Pvt Ltd A tiempo completoArtixio 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...
-
Regulatory Affairs Manager
Encontrado en: Jooble MX O C2 - hace 3 semanas
Ciudad de México Unilever Brazil A tiempo completoFull/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 Specialist Latam
Encontrado en: Jooble MX O C2 - hace 3 semanas
Ciudad de México Red Bull Gruppe A tiempo completoThe legal team protects Red Bull, its people, partners and vendors by adding value to each product line and initiative. Legal is divided into Legal Business Partners for the Beverage Business and Corporate Projects, Specialist Departments and Centers of Expertise. The Regulatory Specialist assists the LATAM Regional team by offering technical and legal...
-
Regulatory Affairs Specialist III
Encontrado en: beBee S MX - hace 1 semana
Ciudad de México Thermo Fisher Scientific A tiempo completoLocation Mexico City, Mexico Job Id R-01227994 Prepares, reviews and coordinates, under guidance and local EC submissions in. Supports preparation, under guidance, of local...
-
Regulatory Specialist Ii
hace 4 días
México Sensient Technologies A tiempo completoAs a valued member of our Sensient global Regulatory team, in this role as a Regulatory Specialist you assure the compliance of our products with appropriate regulations, provide various data, information and conformity declaration, and you serve as a regulatory resource to internal and external customers. You maintain technical databases related to raw...
-
Regulatory Science Analyst
hace 2 días
Ciudad de México Pfizer A tiempo completoWhy 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 Affairs Specialist
hace 4 días
Ciudad de México Johnson & Johnson A tiempo completoEn 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
Encontrado en: beBee S MX - hace 4 semanas
Ciudad de México GSK A tiempo completoSite 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 Specialist Ii
hace 3 días
Ciudad de México Givaudan A tiempo completoJoin us and celebrate the beauty of human experience. Create for happier, healthier lives, with love for nature. Together, with kindness and humility, we deliver food innovations, craft inspired fragrances and develop beauty and wellbeing solutions that make people look and feel good. There’s much to learn and many to learn from, with more than 16,000...
-
LATAM Government Affairs Manager
Encontrado en: Jooble MX O C2 - hace 6 días
Ciudad de México Gateway Recruiting A tiempo completoJob 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 Sciences Strategist Cta Analyst
hace 5 días
Ciudad de México Pfizer A tiempo completoWhy 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...
-
External Affairs Manager
Encontrado en: Jooble MX O C2 - hace 2 semanas
México Bacardi-Martini A tiempo completoKey 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 Specialist 2, FSP
Encontrado en: Jooble MX O C2 - hace 2 semanas
Ciudad de México IQVIA Argentina A tiempo completoJob Overview Perform tasks at a country level associated with Site Activation (SA) activities in accordance with applicable local and/or international regulations, standard operating procedures (SOPs), project requirements and contractual/budgetary guidelines. May also include maintenance activities. Essential Functions • Under general supervision,...