100 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...

(Sr) Regulatory Affairs Consultant CTA/IND - client dedicated (Flexible location UK/EU) United Kingdom, Remote Date posted //2 Job ID R6

We are looking for Regulatory Affairs Professionals on various levels (Senior and Principal Consultant) for a client dedicated project within Oncology. In this role, you will ensure the development of appropriate global and/or regional regulatory strategy(s) and their execution for assigned asset(s) consistent with Medicines Development Strategy /Integrated Asset plan to ensure the development program meets the needs of the key markets identified and the Medicines Profile. This goal has to be achieved while ensuring compliance with both internal process / policy and with appropriate regulatory requirements to deliver the best possible labeling to meet the Medicine Profile, commensurate with the available data. Responsibilities and Accountabilities Proactively developing regulatory strategy that will deliver the needs of the local region(s), taking in to account the needs of other regions globally. Implementation of the regional strategy(s) in support of the...

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,...

The Global Regulatory Affairs Project Director works directly with Global Regulatory Affairs (GRA), Product Development, and Market Access Leadership, GRA personnel, as well as nonclinical and clinical operations, and Finance in managing complex projects and leading the regulatory project management team. This includes the project review process, raising issues for resolution, ensuring action items are completed, and communicating the health of both project and the portfolio to GRA Leadership. Candidate will work with key leaders to manage the overall performance of the portfolio by interpreting metric and project review information resulting in actionable plans to improve delivery efficiencies to our clients. Candidate will assume responsibility for GRA business development activities intended to increase business for regulatory services. Additional responsibilities include leading cross-project and financial processes improvements, mentoring...

Regulatory Affairs Professional - CTR Project Manager client dedicated (flexible location EU/UK) United Kingdom, Remote Date posted //2 Job ID R6

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

The Global Regulatory Affairs Project Director works directly with Global Regulatory Affairs (GRA), Product Development, and Market Access Leadership, GRA personnel, as well as nonclinical and clinical operations, and Finance in managing complex projects and leading the regulatory project management team. This includes the project review process, raising issues for resolution, ensuring action items are completed, and communicating the health of both project and the portfolio to GRA Leadership. Candidate will work with key leaders to manage the overall performance of the portfolio by interpreting metric and project review information resulting in actionable plans to improve delivery efficiencies to our clients. Candidate will assume responsibility for GRA business development activities intended to increase business for regulatory services. Additional responsibilities include leading cross-project and financial processes improvements, mentoring...

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,...

Company Summary BioNTech is a Germany-based biotechnology company with U.S. offices in Cambridge, MA and Gaithersburg, MD, that focuses on developing cancer therapeutics, including individualized immunotherapy, as well as vaccines for infectious diseases, including COVID-19. The company's oncology pipeline contains several classes of drugs, including mRNA-based drugs to encode antigens, neoantigens, cytokines, and antibodies; cell therapies; bispecific antibodies; and small-molecule immunomodulators. BioNTech is partnered with several large pharmaceutical companies, including Roche, Eli Lilly, Pfizer, Sanofi, and Genmab. Comirnaty (COVID-19 vaccine) is its first commercialized product. Primary Responsibilities You will lead all aspects of Regulatory Affairs CMC throughout clinical development. and commercial lifecycle of personalized mRNA oncology vaccines. As you guide these products along this exciting path you will deal with issues of critical importance,...

Regulatory Affairs Professional - CTR Project Manager client dedicated (flexible location EU/UK) United Kingdom, Remote Date posted //2 Job ID R6

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