Regulatory Cmc Project Planner

Created in 2014, Excelya is a people-centered Contract Research Organization (CRO) that excels with care. We offer a personal and authentic experience within a young, ambitious health company on the path to becoming the clinical research leader in Europe thanks to our 800 Excelyates. Our unique one-stop provider service model - leveraging full-service,...

Responsibilities **Mission**: To manage the tracking, review and approval of RtQ including the management of all documents through the document management system for a small mocule in Oncoloy. Small molecule background desirable. **Activities and responsibilities**: Use existing tracker created for the filing of the dossier of a small mocule in Oncoloy to...

Created in 2014, Excelya is a people-centered Contract Research Organization (CRO) that excels with care. We offer a personal and authentic experience within a young, ambitious health company on the path to becoming the clinical research leader in Europe thanks to our 800 Excelyates. Our unique one-stop provider service model - leveraging full-service,...

Regulatory Affairs Specialist 362 In the frame of a project for one of our Top Clients, we are seeking for a Regulatory Affairs Specialist ( pharmacist ) responsible for ensuring the delivery of regulatory activities performed onsite in Paris region. About us Group 10 Responsibilities Under the responsibility of the regulatory coordinator...

**Entreprise**: Our client, a gene therapy biotech, spin-off of Genethon, is searching for his/her CMC Operational Manager. **Poste**: Within a high growth, fast paced small organization, the CMC Analytical Scientist is responsible for providing analytical expertise and leadership in the development and manufacturing of recombinant - adeno associated virus...

We are looking at a Regulatory Affairs Specialist to join and complete our team. You will be responsible for the coordination and preparation of document packages to secure timely approvals and maintain market clearance with a primary focus on EU + Turkey and/or other regions as assigned. **Key Areas of Responsibility** (non-exhaustive list**)**: - Leads...

Prepares and/or reviews regulatory documents to support clinical trial submissions. Independently provides regulatory support for complex projects and programs RESPONSIBILITIES Acts as a Clinical Trial Regulatory Manager (CTRM) on complex clinical trial projects or programs and may act as a Regulatory Oversight for a key customer Ability to...

Roles and Responsibilities: - Ensure project schedule is prepared in accordance with GFD procedures and best practices. Oversee development and maintenance of Critical Path Method logic networks, detailed work plans, and look-aheadplans. identify and mitigate project risks, develop risk management plan - Assist subcontractors in preparation of schedules and...

L'entrepriseHESPERIE CONSEIL est un cabinet de conseil spécialisé en Finance des Marchés et Asset Management. HESPERIE CONSEIL propose ses prestations haut de gamme aux institutions du monde de la finance, Banques de Financement et d’Investissement, Asset Managers et autres acteurs de «l’industrie financière». Description du postePour l'un de nos...

DESCRIPTION: We have an open position for a LEAD REGULATORY ASSOCIATE to join our Regulatory Unit within the clinical operations department.A Lead Regulatory Associate (LRA) is the contact person for the Sponsor for all regulatory advice and support for the assigned projects. The LRA is responsible for coordinating a team of Regulatory Associates (RAs) in a...

We are looking for a Regulatory Affairs Officer to maintain and develop the portfolio in Asia and Sub-Saharan Africa. The position may be based in Boulogne or Toulouse. Group 10 In line with global product regulatory strategies, defines, anticipates, plans and coordinates the implementation of the regulatory strategy for registration, MA...

About the job To maintain ongoing exciting projects, we are urgently looking for a Regulatory Affairs Specialist to join our teams in France. About us Group 10 Responsibilities Preparation of registration files and answers to questions from the authorities Preparation of clinical study authorization request files Preparation of...

Group 10 Responsibilities In the context of a new project for a leading client in the cosmetic field, we are looking for our next Regulatory Affairs Officer to temporarily join our teams. Your responsibilities will include: Edit and make available the list of ingredients Validate the proofs of packaging Prepare and transmit the export...

Job DescriptionContribute to dossier strategy and complex product development plans at a compound level, demonstrating autonomy and accountability.Lead and supervise dossier authoring activities for early and late-stage projects with limited guidance from the manager.Identify areas for business improvement and support the implementation of enhancements under...

Company Description At Turner & Townsend we’re passionate about making the difference. That means delivering better outcomes for our clients, helping our people to realize their potential, and doing our part to create a prosperous society. Every day we help our major global clients deliver ambitious and highly technical projects, in over 110 offices...

Our client is an innovative leading compzny producing pipeline and tubing solutions. This demands various capabilities from the conception and development to the complete project implementation. Its high level expertises leads to get the necessary capabilities to ensure robust solutions are implemented both on time and within budget. Benefits: - Tickets...

**Organisational Environment**: **Mercury is an Irish based European Contractor.** Mercury is a European Contractor that builds and manages complex engineering projects that reimagine how people work and live in the built environment. Our determination and focus enable us to deliver leading-edge construction solutions across a range of key sectors including...

Prepares and/or reviews regulatory documents to support clinical trial submissions. Independently provides regulatory support for more complex projects. RESPONSIBILITIES Acts as a Clinical Trial Regulatory Manager (CTRM) on global projects which may be complex Ability to administratively and technically/scientifically review core scientific...

Job DescriptionManaging the implementation and maintenance of project processes for scheduling.Presenting schedule reports to the project management team and relevant stakeholders.Collaborating with other disciplines to drive towards project goals in keeping with the client's principles of trust, transparency and teamwork.Maintain an awareness of schedule...

In the context of a new project, we are looking for a Regulatory Affairs Officer in medical devises to join our teams in Paris. Group 10 Responsibilities Write the dossiers and coordinate with the different contributors (R&D, Production, QA, Clinical,..) Ensure that the constitution of the registration dossiers is in accordance with the new...