Global Quality Regulatory API Specialist
hace 2 meses
Who we are?
Today, we are a pharmaceutical group with a track record spanning over 45 years and a footprint in more than 50 countries, led by Leandro and Lucas Sigman. Our overarching goal is to improve people's health all over the world, providing accessible, effective, safe, quality medicines through our various business units, underpinned by continuous investment in R&D and cutting-edge technology at all our centres.
General Responsibility:
Support the Global API Quality and Regulatory Director in evaluating the current requirements of the Regulatory Agencies, for what refers API CMOs and JVs sites, specifically from chemistry and solid-state perspective.
The candidate will collect the necessary information and documents from the manufacturers, review them from chemistry and solid-state perspective, and will interact, with the support of the Global API Quality and Regulatory Director, with the manufacturing sites, or as support in case of interactions with the Authorities.
The candidate will contribute to respond to the queries received from the Regulatory Agencies and Customers from chemistry and technical perspective.
The candidate will support the Global API Quality and Regulatory Director in defining the strategies for replying to Deficiency Letters of Customer technical requests.
Specific Responsibilities:
Collect the information about manufacture and controls of the APIs to the manufacturers and verify the adequacy for the initial filings, as well for answering the deficiency letters, specifically from chemistry and solid-state perspective.
As process leader, keep monitored the process lifecycle from chemistry perspective in all the changes proposed and implemented.
Support the head of the function in implementing and reporting as head of projects that the priorities established are afforded and without unknown concern, specifically from chemistry and solid-state perspective.
Support the head of the function in complaints and customer technical requests.
Follow up on the milestones of the projects, by periodical meetings and reporting.
Support the organization with interdepartmental team meetings for implementing the strategies defined along with the Global API Quality and Regulatory Director.
Qualifications:
Education: University Level in Pharmacy, Chemistry, or other relevant Science discipline.
Languages: Fluent English and Spanish.
Experience: 2-5 years experience with technical quality documentation elaboration in a regulated environment (GxP). Preferable in the Chemistry and Solid-State areas.
Specific Knowledge: Advanced Microsoft platform processing user.
Travels: not expected.
Personal Skills: Autonomy, precision, hands-on hard worker, good communicator and technical writer, ability to interact with multicultural and international remote teams, interested in team working.
#J-18808-Ljbffr
-
Global Regulatory Affairs Lead
hace 5 días
Centro, España Sobi group A tiempo completoStatistics show that women and underrepresented groups tend to apply to jobs only if they meet 100% of the qualifications. Sobi encourages you to change that statistic and apply. Rarely do candidates meet 100% of the qualifications. We look forward to your application! At Sobi, each person brings their unique talents to work as a team and make a...
-
Senior Quality Specialist
hace 1 mes
Centro, España Takeda A tiempo completoBy clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice and Terms of Use . I further attest that all information I submit in my employment application is true to the best of my knowledge....
-
Senior Quality Specialist
hace 2 meses
Centro, España Takeda A tiempo completoBy clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice and Terms of Use . I further attest that all information I submit in my employment application is true to the best of my knowledge. Job...
-
Senior Quality System Specialist
hace 2 meses
Centro, España Boston Scientific A tiempo completoAbout the role : The Senior Quality System Specialist will serve as a key Regional Quality Functional Representative on the Magellan Program for EMEA Satellite Offices (SO), working closely with the EMEA Magellan Distribution Quality Lead and EMEA Quality Core team, to assess, evaluate the Magellan implementation impact locally on the EMEA Satellite offices...
-
Senior Quality Specialist
hace 2 meses
Centro, España Takeda A tiempo completoAbout the role : This role will be responsible for Quality activities in relation to Takeda Products commercial activities at Takeda Iberia Local Operating Company (LOC), which includes ensuring that a quality management system is implemented and maintained in accordance with the Guidelines on Good Distribution Practice for medicinal products for human use...
-
Regulatory and Start Up Specialist 2
hace 2 meses
Centro, España IQVIA 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. Specialized in ICF. Essential Functions Under general...
-
Associate Director, Regulatory Affairs
hace 1 mes
Centro, España Cpl Healthcare A tiempo completoJob Title: Associate Director, Regulatory Affairs - Medical Device/Post-Market Surveillance Job Type: Full Time, Permanent Position Location: Spain, Madrid – Hybrid Remuneration: Attractive salary and package An exciting opportunity to join a growing pharmaceutical company that specializes in Cancer and Supportive Care, Gastroenterology, and...
-
Regulatory Manager
hace 2 meses
Centro, España Parexel A tiempo completoWhen our values align, there's no limit to what we can achieve. Are you an experienced regulatory professional looking for a new opportunity? We are currently seeking a talented CMC Regulatory Manager (Regulatory Affairs Consultant) to join our dynamic team! This is a client dedicated project, and the role can be office or home based in various European...
-
Junior Manager Regulatory Affairs CMC
hace 2 meses
Centro, España Mabxience A tiempo completoOverview: The Junior Manager, Regulatory Affairs CMC is responsible to provide regulatory relevant technical assistance to development teams and ensures adequacy of CMC documentation for global regulatory submissions including specific requirements for regional registration processes. The position supports and promotes all regulatory CMC tasks throughout the...
-
Quality Assurance Engineeer
hace 2 meses
Centro, España Holtec International A tiempo completoHoltec Europe is seeking an experienced professional with project engineer expertise to support the growth of the company’s core business in the energy industry, specifically in Quality Assurance Engineering. S/he will be responsible for helping to shape and manage the development and deployment of the SMR quality assurance arrangements, processes, and...
-
Quality Coordinator
hace 1 mes
Centro, España Exeltis A tiempo completoOverview: Ensuring that appropriate Quality systems are established, implemented, and maintained in each market in scope, and appropriate oversight is in place to ensure that local regulatory requirements can be supported in a simple, compliance and continuous improvement manner. Responsibilities: Keep the documentation of the manual, processes and...
-
Global GMP Senior Auditor
hace 5 días
Centro, España Healthcare Businesswomen’s Association A tiempo completoJob Description Summary The future is (y)ours to shape! Job Description At Sandoz, our goal is not just to increase access, but to do so in a sustainable and responsible way: Finding the right balance between guaranteed quality, reliable supply, and appropriate pricing. Our aim is to excel at all three, ensuring we never compromise on quality. To protect...
-
Global GI HR Specialist
hace 2 meses
Centro, España HITACHI ENERGY SPAIN, S.A.U. A tiempo completoDescription The opportunity: Are you passionate about HR and Data Analytics? Do you thrive in a global and diverse organization? We are seeking a dedicated Global GI HR Specialist to join our HR Team in the Grid Integration Business. As a core member, you will support the GI HR Community and Business Managers, leveraging advanced data analytics techniques...
-
Compliance Governance Specialist
hace 2 meses
Centro, España Payoneer Inc. A tiempo completoBuild Your Career | Love your Work | Make a Difference Payoneer’s mission is to empower businesses to go beyond – beyond borders, limits and expectations. In today’s digital world, Payoneer enables businesses of all sizes from anywhere in the world to access new economic opportunities by enabling them to transact globally as easily as they do...
-
Global GI HR Specialist
hace 2 meses
Centro, España Hitachi Vantara Corporation A tiempo completoDescription The opportunity: Are you passionate about HR and Data Analytics? Do you thrive in a global and diverse organization? We are seeking a dedicated Global GI HR Specialist to join our HR Team in the Grid Integration Business. As a core member, you will support the GI HR Community and Business Managers, leveraging advanced data analytics...
-
Supplier Quality Specialist
hace 2 meses
Centro, España Vestas A tiempo completoSupplier Quality Specialist - (Welding Engineer Expert) Capex & Tools- Madrid (ES) Posted: 11 October 2024 Requisition ID: 59428 Location: Madrid, M, ES Work experience: Specialist Type of position: Full-Time Job Family: Quality, Health, Safety and Environment Are you a passionate Engineer? Do you have significant experience as a welding engineer? Are...
-
Director Global Pharmacovigilance
hace 2 meses
Centro, España Teva A tiempo completoDirector Global Pharmacovigilance - Safety Physician Lead the safety profile of the assigned product(s) during clinical development including Company Sponsored studies, Investigator Sponsored studies, Compassionate Use and Disease Monitoring Programs. Collaborate with other R&D teams to ensure execution of the safety strategy. Contribute to clinical...
-
Energy Sourcing
hace 1 mes
Centro, España Essity AB A tiempo completoEnergy Sourcing & Regulatory Affairs Manager - Spain About the Role This position supports the strategy for energy procurement in Spain by sourcing energy for high-consumption sites within the framework of the global energy risk policy. You will manage regulatory issues related to energy consumption in Spain, ensuring compliance and competitiveness. We're...
-
Quality Control Analyst
hace 1 mes
Centro, España MSX INTERNATIONAL A tiempo completoQuality Assurance Specialist Do you have solid experience evaluating the quality and functionality of Contact Center teams with operations for multiple markets and are you ready to take on new challenges? This is your role in MSX! Purpose of the Position: The Quality Assurance Specialist is responsible for monitoring and evaluating the quality of...
-
Contract Specialist
hace 1 mes
Centro, España Ora A tiempo completoPOSITION TITLE: Contract Specialist DEPARTMENT: Ora Europe LOCATION: Remote in UK, Spain, Italy or Poland Ora Values the Daily Practice of … Prioritizing Kindness * Operational Excellence * Cultivating Joy * Scientific Rigor ______________________________________________________________________________ At Ora, we are building the future of ophthalmic...