Empleos actuales relacionados con Regulatory Affairs Manager - Desde casa - Atnahs
-
Regulatory Affairs Manager
hace 3 meses
Desde casa, México Atnahs A tiempo completo**Based in Mexico (remote)**: **Salary: Competitive + Bonus + Benefits**: If you are an agile, committed, and innovative regulatory affairs professional in the pharmaceuticals sphere, then we want to hear from you! Join us to help improve peoples’ lives and make healthcare better for everyone! **Why Pharmanovia?**: Pharmanovia is a dynamic, fast-growing...
-
Regulatory Affairs Specialist, Latam
hace 3 meses
Desde casa, México IQVIA A tiempo completo**POSITION TITLE**: Regulatory Affairs Specialist **REPORTS TO**: Manager, Regulatory Affairs or Designee **BASIC FUNCTIONS**: **ESSENTIAL JOB FUNCTIONS, DUTIES AND RESPONSIBILITIES**: - Assist Manager, Regulatory Affairs, in assuming primary or secondary regulatory responsibility for assigned clinical research projects by providing regulatory...
-
Regulatory Affairs Specialist
hace 5 meses
Desde casa, México Thermo Fisher Scientific A tiempo completo**Summarized Purpose**: Provides innovative solutions including regulatory expertise and client interface to provide strategic intelligence, and guidance supporting product development from preclinical through registration and product optimization. Provides strategic, expedient and efficient preparation of client deliverables that meet current local,...
-
Regulatory Affairs Specialist
hace 4 meses
Desde casa, México ICON A tiempo completoAs a Regulatory Affairs Specialist you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence. **What you will be doing**: - Regulatory advice to drug development is key to ensuring our clients pursue first time right strategies to overall product development and to clinical programme...
-
Sr Reg Affairs Spec
hace 2 semanas
Desde casa, México Thermo Fisher Scientific A tiempo completo**Work Schedule** Standard (Mon-Fri) **Environmental Conditions** Office We are currently seeking a Senior Regulatory Affairs Specialist to join our global Regulatory Affairs department. This is a fantastic opportunity to further develop your regulatory career and expertise in a global clinical trial setting. In this role you will be a pivotal team...
-
Sr Reg Affairs Spec
hace 3 meses
Desde casa, México Thermo Fisher Scientific A tiempo completoWe are currently seeking a Senior Regulatory Affairs Specialist to join our global Regulatory Affairs department. This is a fantastic opportunity to further develop your regulatory career and expertise in a global clinical trial setting. In this role you will be a pivotal team member with regulatory affairs responsibilities, leading discussions, and...
-
Regulatory Affairs Associate
hace 5 meses
Desde casa, México Parexel A tiempo completoAn Associate must have a knowledge of the organization´s basic consulting models and methodologies as well as basic knowledge of what services the department provides. An Associate must be technically competent and continually developing the skills as defined in the department, under general direction of his/her Line Manager and Supervisor, taking...
-
Senior Reg Affairs Specialist
hace 3 meses
Desde casa, México Thermo Fisher Scientific A tiempo completoAt Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through...
-
Sr Reg Affairs Specialist
hace 4 meses
Desde casa, México Thermo Fisher Scientific A tiempo completoAt Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through...
-
Sr Reg Affairs Spec
hace 4 meses
Desde casa, México Thermo Fisher Scientific A tiempo completoAt Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through...
-
Regulatory Publishing Specialist
hace 4 meses
Desde casa, México Thermo Fisher Scientific A tiempo completo**Regulatory Publishing Specialist** The Regulatory Publishing Specialist provides experienced moderate, expedient and efficient preparation of client electronic submission deliverables and dossier that meet current local, regional and ICH regulatory and technical requirements. Ensures successful regulatory review outcomes for product milestones. Serves in...
-
Regulatory Specialist 2, Fsp
hace 4 meses
Desde casa, México IQVIA A tiempo completo**Job 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,...
-
Regulatory & Start Up Specialist, Cfsp
hace 3 meses
Desde casa, México IQVIA A tiempo completoWe are looking for a **Regulatory & Start Up Specialist** to join our cFSP team in a Home Based role! **Location**: Argentina & México **What You´ll Do** 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...
-
Clinical Trial Reg Affairs Specialist Ii
hace 5 meses
Desde casa, México Thermo Fisher Scientific A tiempo completoAct as an administrator for our in-house Regulatory Intelligence database and provide customer support for issues arising. - Regulatory collaboration with Regulatory Intelligence database workflow users to drive quarterly EQR metrics. - Contribute to a wide range of technical Regulatory Intelligence database content projects including engineering and...
-
Fsp - Regulatory and Start Up Specialist Mex
hace 4 meses
Desde casa, México IQVIA A tiempo completoWe are looking for a **Regulatory & Start Up Specialist** to join our FSP team in a Home Based role! **Job 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...
-
Reg Affairs Spec
hace 4 meses
Desde casa, México Thermo Fisher Scientific A tiempo completoSupports the preparation of documentation and submissions under guidance - Coordinates and manages client deliverables supporting regulatory compliance - Liaises with internal and external clients in the tracking and status update of project plans and overall support of projects - Assists with project budgeting/forecasting - Maintains knowledge and...
-
Prin Reg Affairs Assistant
hace 4 meses
Desde casa, México Thermo Fisher Scientific A tiempo completoSummarized Purpose: Provides advanced administrative support to the department and supports reporting of such to upper management. Essential Functions - Track each regulatory submission in required tracker system (PPD or sponsor), (Veeva, eTMF, Activate, CTMS). - Review Sharepoint to ensure correct regulatory information is captured as per the tracked...
-
Regulatory Affairs Associate Maa
hace 2 semanas
Desde casa, México Parexel A tiempo completoThis role's main activities will be: - Dossier management including MA submission and MA renewals. - Perform new dossiers for new marketing authorizations (local or international). - Handling of documentation for marketing authorization renewals and artwork managing. - Review SmPCs and PSURs. - Communication with local HA and clients. - Respond to any...
-
Drug Safety Reporting Senior
hace 5 meses
Desde casa, México Thermo Fisher Scientific A tiempo completoReceives, prepares, and submits safety reports to applicable parties. Ensures that all reports are compliant with regulatory timelines and country legislation and monitors this on a regular basis. - Identifies and resolves any quality or timeline issues and keeps the Manager informed of progress. - Exercises independent judgment to troubleshoot, resolves...
-
Clinical Operations Manager
hace 4 meses
Desde casa, México Allucent A tiempo completoAt Allucent, we are dedicated to helping small-medium biopharmaceutical companies efficiently navigate the complex world of clinical trials to bring life-changing therapies to patients in need across the globe. We are looking for a Clinical Operations Manager (COM) to join our A-team (hybrid*/remote). As a COM at Allucent, you will provide leadership,...
Regulatory Affairs Manager
hace 3 meses
Based in Mexico (remote):
Salary:
Competitive + Bonus + Benefits:
If you are an agile, committed, and innovative regulatory affairs professional in the pharmaceuticals sphere, then we want to hear from you
Join us to help improve peoples' lives and make healthcare better for everyone
Why Pharmanovia?:
Pharmanovia is a dynamic, fast-growing international pharmaceutical company with a portfolio of over 20 brands across more than 160 markets.
Our core behaviours are:
- We act decisively but we never compromise on quality.
- We keep our promises and do as we say.
- We value our heritage and foster an entrepreneurial spirit.
- We reinvest in our future in our products, our brands, and our people.
- We give back to our communities.
Since its inception in 2013, Pharmanovia has grown consistently year on year, focusing on delivering high-quality branded prescription medicines to patients, prescribers, and healthcare providers across the world.
Our growth has enabled the company to reinvest in its products, brands, people, and to give back to its communities.
A people business with a strong, supportive culture that encourages innovation and entrepreneurial spirit, our team comprises over 300 employees and 29 nationalities, operating from offices in the UK, Denmark, Netherlands, Switzerland, U.A.E., India, Singapore, Italy, Spain, and South Korea.
We are an agile, committed, and innovative global specialty pharma business and a preferred partner for innovator pharma companies, instigating a paradigm shift in the life cycle management of iconic medicines.
We seek to extensively engage with clinical communities to communicate product improvements and prioritise environmental, social, and governance considerations across the business and workforce.
Pharmanovia's therapeutic areas include Cardiovascular, Oncology, Endocrinology and Neurology.About the role:
Reporting to the Global RA Lead, as Regulatory Affairs Manager (or Senior Manager, depending on experience) you will lead the establishment of Regulatory Affairs management in the LATAM region.
In this role you will work closely with the Global Regulatory Lead, Regulatory Product Leads, Scientific Affairs and General Manager in cross-functional project teams, to ensure LATAM growth strategies are realised.
Our Regulatory Affairs Department has an ethos of continuous improvement, refining systems and creating efficiencies. This, along with the rapid growth of the business, leads to a varied and dynamic working environment.Main responsibilities & duties:
- Lead Pharmanovia's Regional operations strategically aligned to growth plans in LATAM
- Establish regional infrastructure and ensure regulatory compliance with the national competent authority legislation for the marketing and distribution of Pharmanovia's products
- Establish regulatory strategies and develop submissions for CTAs, CTA exemptions, NDA submission, preNDA meetings, lifecycle management and labelling management
- Regional regulatory lead representing due diligence assessments and development opportunities
- Ensure planning and optimal organisation of regional regulatory activities
- Drive growth opportunities in LATAM through strategic planning and in depth understanding of the regulatory framework in LATAM
- Ensure full readiness and compliance of the local entity and all related activities for products commercialization
- Serve as a critical member of the Regulatory Affairs team providing LATAM focused product development strategies and the registration of foreign developed products
- Lead interactions and submissions with the COPEFRIS and related Health Authorities for LATAM markets
- Monitor, identify and communicate regulatory environmental trends and regulation development which would influence Pharmanovia's growth opportunities
About you:
- Master's degree or above in pharmacy, medicine or chemical sciences
- Great IT skills including MS Word, Excel, Project, PowerPoint, and Outlook
- Proven record and recent experience of CTA/NDA and associated strategy in LATAM
- Good understanding of the regulatory infrastructure required for the marketing and distribution of pharmaceutical products
- Strong knowledge of local regulatory framework and guidelines
- Must be able to independently present complex global regulatory strategies internally and to Pharmanovia's partners
- Expertise in writing scientific and technical documents, and strong attention to detail with proofreading materials
- Overall global expertise, professional gravitas and strong influence skills and will display personal and professional maturity
- Data driven in decision making with the ability to analyse complex situations, focus on the key iss
