Search Results: 29 vacancies
...to continue making a difference, and new people to make a difference with.
The opportunity
To organize and perform required regulatory tasks in order to maintain existing EU procedures in line with current regulations, guidelines and in-house standard
To obtain...
Regulatory
Local area
...difference, and new people to make a difference with.
The opportunity
This position provides medical and scientific expertise for regulatory submissions and implies in-depth expertise within medical science, with primary goal of authoring clinical and non-clinical...
Regulatory
Remote job
...make a difference with.
How you’ll spend your day
Assess submission documentation in consideration and compliance with the regulatory requirements and to provide inputs to cross functional teams.
Coordinate (on need basis) with external parties and cross functional...
Regulatory
...Involved in new product scale up, process validation and commercialization by following TAPI Technology Transfer Policy and meeting regulatory requirements.
Study of process of new molecules, Generation of kinetics & collection of data’s based on lab scale batches & R&...
Regulatory
...approach.
Hands on experience on Instruments viz., GC, HPLC, Ion Chromatography, UV and Dissolutions apparatus etc.
Knowledge of regulatory requirements for different markets (US, EU, Canada etc.)
Knowledge on ICH guidelines, forced degradation studies, impurity...
Regulatory
...experience
~2-4 years’ direct experience with Information Security Technologies or Data Privacy Consulting or PCI-DSS Consulting and regulatory requirements like SOX, GLBA, HIPAA, SOC1
~ Experience in programming language like Java, Python
~ Solid problem-solving skills...
Regulatory
...know how of different equipment's used in solid oral manufacturing
Good learning acumen
Good understanding of cGMP and local regulatory body requirements for GMP batches manufacturing
Skills and Specific Knowledge Required
People Skills
Must be confident,...
Regulatory
Local area
...diversified experience across various business functions. Excellent communication skills, a technical understanding of food safety and regulatory requirements, and experience in public speaking and negotiation are also key attributes. The ideal candidate will be adept at...
Regulatory
Full time
...stakeholder relationships effectively. A solid understanding of financial products and the ability to adapt strategies in response to regulatory changes are also essential.
This role requires a professional with a background in finance, economics, or engineering, and at...
Regulatory
Full time
...investigation etc.
Responsible for assuring / coordinating for timely shipment, delivery, and/or receipt to assure compliance with regulatory requirements. In addition, responsible to assure appropriate shipping instructions, coordinate/approve route validation and...
Regulatory
...hybrid cloud deployment solutions that will enable the use of Hybrid cloud infrastructure to meet the challenges of technology, regulatory, and security requirements
Manage Network adopting DevOps/SRE principles. Own the design, low-level engineering, and delivery...
Regulatory
Local area
Remote job
...day
Work closely with Site Management, GFM lead and Global Corporate Security to understand corporate requirements related to regulatory compliance and to map those requirements to current site.
Implementation of Global Corporate Policy at site with local alignments...
Regulatory
Local area
...people to make a difference with.
How you’ll spend your day
~24 × 7 audit readiness.
~ Participation in internal, external, regulatory audits.
~ Ensure 100% participation in training’s against CAPA’s.
~ Responsible for initiation and investigation on LIR, OOS,...
Regulatory
...interacts with the Team Leader and the QRM’s and if required other departments such as Operations, Procurement, Supply Chain, MS&T, and Regulatory Affairs and provides complete support from quality perspective.
The position is to review the QMS documents like batch records...
Regulatory
...Atypical Analytical Test results
6-Instrument daily Calibration as: pH meter, Analytical balance.
7-Should be skilled to handled regulatory inspection.
8-Follow the defined safety procedure during day to day activity in laboratory.
9-Maintenance of spares/...
Regulatory
...report into this position.
How you’ll spend your day
1. SAP Operations Management:
Ensure SAP services adhere to SLAs and regulatory requirements.
Collaborate with IT stakeholders and business units for effective SAP utilization.
2. Project Management and...
Regulatory
Local area
...when assigned.
Conduct internal study audit, and system audits to check compliance with GCP/GLP, Protocols, SOPs and applicable regulatory requirements.
Review Change Control and evaluate its impact.
Review deviation and CAPA's and evaluate its impact....
Regulatory
...commercialization, including product design and engineering, preclinical and clinical development, data management, market access, regulatory affairs and quality assurance, Veranex enables accelerated speed to market, controlled development costs, development risk...
Regulatory
Temporary work
...and external stakeholders.
Collaborate with internal and external stakeholders to align project goals with EMSO objectives and regulatory requirements.
Project Planning and Execution:
Lead the development of project plans, including scope, timelines, resources...
Regulatory
...process optimization, technology integration, quality assurance, capacity planning, team leadership, cross-functional collaboration, regulatory compliance, and cost management. The ideal candidate will have a proven track record in leading the development and...
Regulatory
Full time
