38 regulatory affairs jobs found

FSP Regulatory Affairs Consultant - CTR (flexible location UK/EU) United Kingdom, Remote Date posted //2 Job ID R4

We are currently looking for a Regulatory Affairs Professionals to join one of our clients and act as a (Senior) Regulatory Affairs Consultant CTR. This role can be based in either UK or UE (home/office based) and we have flexibility on levels. In this role you will work closely with other departments to design, implement applications & systems to support regulatory business processes. You will work with key stakeholders to map current processes and organize task forces to define and implement process improvements. You will support the organization by analyzing (as business analyst) and managing and/or coordinating EU CTR process changes and organizational changes. Role responsibilities: Draw models for the business processes (process flows) Moderate workshops with business experts Ensure good communication with stakeholders in the project (verbally and written) Draft new procedures based on new business processes & user requirements...

We are looking for Regulatory Affairs Professionals CTA/INDon various levels (Consultant, Senior Consultant, Principal Consultant) for a client dedicated project within Parexel FSP Group. The role can be home or office based in various European locations. As the Regulatory Affairs CTA/IND Specialist you will provide technical/coordination support and expertise within the client's vaccines group in particular for the R&D, Global Quality Vaccines & Legal/Patent departments and outside of the group (eg: EMA) to ensure: The appropriate project management related to CTA/IND process with the different stakeholders by issuing the master planning/strategy to ensure timely due submissions and approvals of CTA’s/IND in compliance with ethical and regulatory standards The upload and maintenance of the third country form (related to articles 41 & 46) via the EMA gateway The appropriate project management related to DSUR process with the different...

We are looking for Regulatory Affairs CTA Professionals on various levels to join our client dedicated project. In this role you will be responsible for managing and submitting the dossier to those competent authorities. The role can be either remote or office based and we have flexibility in a location (UK, EU countries) Role responsibilities: Works within a team environment or individually based on the project needs Works within broad project guidelines and facilitates issue and conflict resolutions developments/improvements - Demonstrates the use of the organization’s consulting models and methodologies and uses experience to suggest possible Provides a full range of technical and/or business consulting services within personal area of expertise dealing mainly in areas where policy or precedent is clear Completes activities and may delegate activities within project scope and objectives in a timely manner with an understanding of issues which...

Job Responsibilities: Write CMC, “facility and equipment” parts and new files for WW regulatory FileManage and schedule with SMEs and Site conformance (and Production, Validation and Quality Assurance) the writing/review process to ensure timely completionEnsure the coordination with the departments involved in the writing/review processWrite and support regulatory affairs Responses to Questions raised by Regulatory AuthoritiesMonitor that supportive data provided by other departments are compliantReport significant issuesManage the projects within all tracking toolsAssess the change controls that relate to pure facilities and equipment matters or work with GRL teams for change controls impacting both CMC and facilities. Skills and Experience required for the role:Experience in writing CMC (technical) parts of regulatory documents (registration files or variations).Experience working in validation/QA/production in Biologics/Pharmaceuticals industryKnowledge of regulatory...

Regulatory Affairs - CMC Technical Writer (flexible location UK/EU) United Kingdom, Remote Date posted //2 Job ID R9

We are currently looking for a (Senior) Regulatory Affairs Consultant to join one of our clients and act as EU CTR Submission Project Manager for Regulatory Affairs. This role can be based in either UK or UE (home/office based) and we have flexibility on levels. In this role you will work closely with IT Project Manager to design, implement applications & systems to support regulatory business processes. This includes the analysis of the demand, the realization of the application through customization/development and testing. You will work with key stakeholders to map current processes and organize task forces to define and implement process improvements. You will develop documentation and training package and support activities (response to questions from users). You will support the organization by analyzing (as business analyst) and managing and/or coordinating EU CTR process changes and organizational changes. You may also deliver project management,...

Regulatory Affairs - CMC Technical Writer (flexible location UK/EU) United Kingdom, Remote Date posted //2 Job ID R9

Job Responsibilities: Write CMC, “facility and equipment” parts and new files for WW regulatory FileManage and schedule with SMEs and Site conformance (and Production, Validation and Quality Assurance) the writing/review process to ensure timely completionEnsure the coordination with the departments involved in the writing/review processWrite and support regulatory affairs Responses to Questions raised by Regulatory AuthoritiesMonitor that supportive data provided by other departments are compliantReport significant issuesManage the projects within all tracking toolsAssess the change controls that relate to pure facilities and equipment matters or work with GRL teams for change controls impacting both CMC and facilities. Skills and Experience required for the role:Experience in writing CMC (technical) parts of regulatory documents (registration files or variations).Experience working in validation/QA/production in Biologics/Pharmaceuticals industryKnowledge of regulatory...

Vacancies Regulatory Affairs, Senior Specialist (Hybrid Onsite/Remote - PA, NJ, NY, DE, MD) Job Title:Regulatory Affairs, Senior Specialist (Hybrid Onsite/Remote - PA, NJ, NY, DE, MD) Reference:QA-22-65 Location US ~ Homebased Type: Full Time Company Overview Quotient Sciences is a drug development and manufacturing accelerator providing integrated programs and tailored services across the entire development pathway. Cutting through silos across a range of drug development capabilities, we help biotech and pharma customers save precious time and money in getting drugs to patients. As a growing and successful business, we employ more than 1, talented individuals globally, located at state-of-the-art development, manufacturing and clinical facilities in the UK and USA. Science, Agility and Culture are the core components that define Quotient Sciences, enabling us to do what we do in the way that we do it. People join Quotient Sciences because we are a...

We are currently looking for a (Senior) Regulatory Affairs Consultant to join one of our clients and act as EU CTR Submission Project Manager for Regulatory Affairs. This role can be based in either UK or UE (home/office based) and we have flexibility on levels. In this role you will work closely with IT Project Manager to design, implement applications & systems to support regulatory business processes. This includes the analysis of the demand, the realization of the application through customization/development and testing. You will work with key stakeholders to map current processes and organize task forces to define and implement process improvements. You will develop documentation and training package and support activities (response to questions from users). You will support the organization by analyzing (as business analyst) and managing and/or coordinating EU CTR process changes and organizational changes. You may also deliver project management,...

Job Responsibilities: Write CMC, “facility and equipment” parts and new files for WW regulatory FileManage and schedule with SMEs and Site conformance (and Production, Validation and Quality Assurance) the writing/review process to ensure timely completionEnsure the coordination with the departments involved in the writing/review processWrite and support regulatory affairs Responses to Questions raised by Regulatory AuthoritiesMonitor that supportive data provided by other departments are compliantReport significant issuesManage the projects within all tracking toolsAssess the change controls that relate to pure facilities and equipment matters or work with GRL teams for change controls impacting both CMC and facilities. Skills and Experience required for the role:Experience in writing CMC (technical) parts of regulatory documents (registration files or variations).Experience working in validation/QA/production in Biologics/Pharmaceuticals industryKnowledge of regulatory...

Regulatory Affairs - CMC Technical Writer (flexible location UK/EU) United Kingdom, Remote Date posted //2 Job ID R9

FSP Regulatory Affairs Consultant - CTR (flexible location UK/EU) United Kingdom, Remote Date posted //2 Job ID R4

We are currently looking for a Regulatory Affairs Professionals to join one of our clients and act as a (Senior) Regulatory Affairs Consultant CTR. This role can be based in either UK or UE (home/office based) and we have flexibility on levels. In this role you will work closely with other departments to design, implement applications & systems to support regulatory business processes. You will work with key stakeholders to map current processes and organize task forces to define and implement process improvements. You will support the organization by analyzing (as business analyst) and managing and/or coordinating EU CTR process changes and organizational changes. Role responsibilities: Draw models for the business processes (process flows) Moderate workshops with business experts Ensure good communication with stakeholders in the project (verbally and written) Draft new procedures based on new business processes & user requirements...

We are looking for Regulatory Affairs Professionals CTA/INDon various levels (Consultant, Senior Consultant, Principal Consultant) for a client dedicated project within Parexel FSP Group. The role can be home or office based in various European locations. As the Regulatory Affairs CTA/IND Specialist you will provide technical/coordination support and expertise within the client's vaccines group in particular for the R&D, Global Quality Vaccines & Legal/Patent departments and outside of the group (eg: EMA) to ensure: The appropriate project management related to CTA/IND process with the different stakeholders by issuing the master planning/strategy to ensure timely due submissions and approvals of CTA’s/IND in compliance with ethical and regulatory standards The upload and maintenance of the third country form (related to articles 41 & 46) via the EMA gateway The appropriate project management related to DSUR process with the different...

We are looking for Regulatory Affairs CTA Professionals on various levels to join our client dedicated project. In this role you will be responsible for managing and submitting the dossier to those competent authorities. The role can be either remote or office based and we have flexibility in a location (UK, EU countries) Role responsibilities: Works within a team environment or individually based on the project needs Works within broad project guidelines and facilitates issue and conflict resolutions developments/improvements - Demonstrates the use of the organization’s consulting models and methodologies and uses experience to suggest possible Provides a full range of technical and/or business consulting services within personal area of expertise dealing mainly in areas where policy or precedent is clear Completes activities and may delegate activities within project scope and objectives in a timely manner with an understanding of issues which...

The Role R&D Consulting at Veeva is a unique group fusing strategy and operations with data and technology. Establishing a leading R&D consulting practice is a strategic priority for Veeva, with high visibility within the company and to leaders of the wider Life Sciences industry.As a Principal working within a company at the forefront of digital innovation in the Life Sciences, you will help grow our practice in Europe. The focus will be on building our brand in the market, developing our customer network and identifying and acquiring new projects to support our customers to deliver on their complex business challenges. What You'll Do Lead business development opportunities – identify and generate new project opportunities, clarify customers challenges and needs, be able to develop a compelling, differentiated proposal to solve these issues, and win new work Leverage your network to identify opportunities and develop our business and build new relationships...

The Role We are seeking talented individuals to join the Veeva Business Consulting group in R&D, a priority area for Veeva. We work with senior customer stakeholders, as the partner of choice for 85% of the top 20 Pharmaceutical companies, to define and realize the strategic value of Regulatory Affairs, Clinical Strategy & Operations as well as Quality and Safety (eg. Pharmacovigilance). As a Senior Consultant, you will manage complex and novel consulting projects for Veeva customers in the research and development (R&D) space – managing teams and planning, organizing, and tracking all aspects of delivery. You will analyze interesting problems, build insightful solutions, and develop close working relationships with stakeholders to deliver realizable value, at the forefront of digital and R&D innovation. Opportunities are available across Europe for this role as this is a remote position. There is no work location requirement if a candidate is in proximity to an...

The Role We are seeking talented individuals to join the Veeva Business Consulting group in R&D, a priority area for Veeva. We work with senior customer stakeholders, as the partner of choice for 85% of the top 20 Pharmaceutical companies, to define and realize the strategic value of Regulatory Affairs, Clinical Strategy & Operations as well as Quality and Safety (eg. Pharmacovigilance). As a Consultant, you will manage workstreams on consulting projects for Veeva customers in R&D – planning, organizing, and tracking all aspects of delivery. You will analyze problems, build insightful solutions, and develop close working relationships with customer stakeholders (through face-to-face discussions, workshops, email, etc.) to deliver demonstrable, sustainable value, at the forefront of digital and R&D innovation. Opportunities are available across Europe for this role as this is a remote position. There is no work location requirement if a candidate is in proximity...