Current jobs related to Associate Director, Translations Regulatory Submissions Project Management - Reading - Iqvia
-
Reading, United Kingdom IQVIA Full timeThe Associate Director – Regulatory Submissions is responsible to lead a worldwide Regulatory Submissions delivery team within IQVIA Translations. This team is in charge of the development and harmonization of the Regulatory Submissions Process. The Associate Director – Regulatory Submissions has experience working with QRDs, CTDs, SmPC, PIL and any...
-
Director of Regulatory Submissions Operations
2 weeks ago
Reading, Reading, United Kingdom IQVIA Full timeJob Summary:The Associate Director – Regulatory Submissions is a key leadership role within IQVIA Translations, responsible for leading a worldwide Regulatory Submissions delivery team. This team is responsible for the development and harmonization of the Regulatory Submissions Process, working with QRDs, CTDs, SmPC, PIL, and other regulatory materials for...
-
Director of Regulatory Submissions Operations
2 weeks ago
Reading, Reading, United Kingdom IQVIA Full timeJob Summary:The Associate Director – Regulatory Submissions is a key leadership role within IQVIA Translations, responsible for leading a worldwide Regulatory Submissions delivery team. This team is responsible for the development and harmonization of the Regulatory Submissions Process, working with QRDs, CTDs, SmPC, PIL, and other regulatory materials for...
-
Translation Project Manager
1 week ago
Reading, Reading, United Kingdom IQVIA Full timeJob Summary:The Translation Project Manager - Regulatory Submissions is responsible for coordinating and managing the full lifecycle of Regulatory Submissions translation and localization projects to completion while ensuring IQVIA's standards are met.Key Responsibilities:Manage multiple Regulatory Submissions translation and localization projects at any one...
-
Translation Project Manager
1 week ago
Reading, Reading, United Kingdom IQVIA Full timeJob Summary:The Translation Project Manager - Regulatory Submissions is responsible for coordinating and managing the full lifecycle of Regulatory Submissions translation and localization projects to completion while ensuring IQVIA's standards are met.Key Responsibilities:Manage multiple Regulatory Submissions translation and localization projects at any one...
-
Regulatory Submissions Project Manager
5 days ago
Reading, Reading, United Kingdom IQVIA Full timeJob Title: Translation Project Manager – Regulatory SubmissionsAbout the Role:We are seeking a highly skilled Translation Project Manager to join our team at IQVIA. As a key member of our Project Management team, you will be responsible for coordinating and managing the full lifecycle of Regulatory Submissions translation and localization projects to...
-
Regulatory Submissions Project Manager
5 days ago
Reading, Reading, United Kingdom IQVIA Full timeJob Title: Translation Project Manager – Regulatory SubmissionsAbout the Role:We are seeking a highly skilled Translation Project Manager to join our team at IQVIA. As a key member of our Project Management team, you will be responsible for coordinating and managing the full lifecycle of Regulatory Submissions translation and localization projects to...
-
Regulatory Affairs Director
4 days ago
Reading, Reading, United Kingdom ICON Plc Full timeDirector, Regulatory Affairs - Medical Devices - EMEAAt ICON Plc, we're committed to fostering an inclusive environment that drives innovation and excellence. We're seeking a highly skilled Director, Regulatory Affairs to join our team and contribute to shaping the future of clinical development.The Role:Develop and implement regulatory strategies for...
-
Regulatory Affairs Director
4 days ago
Reading, Reading, United Kingdom ICON Plc Full timeDirector, Regulatory Affairs - Medical Devices - EMEAAt ICON Plc, we're committed to fostering an inclusive environment that drives innovation and excellence. We're seeking a highly skilled Director, Regulatory Affairs to join our team and contribute to shaping the future of clinical development.The Role:Develop and implement regulatory strategies for...
-
Regulatory Affairs Director
2 weeks ago
Reading, Reading, United Kingdom Icon plc Full timeJob DescriptionJob Title: Regulatory Affairs DirectorCompany: ICON plcLocation: EMEAJob Type: Full-timeIndustry: Healthcare, Medical DevicesAbout Us:ICON plc is a world-leading healthcare intelligence and clinical research organization. We're proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our...
-
Regulatory Affairs Director
2 weeks ago
Reading, Reading, United Kingdom Icon plc Full timeJob DescriptionJob Title: Regulatory Affairs DirectorCompany: ICON plcLocation: EMEAJob Type: Full-timeIndustry: Healthcare, Medical DevicesAbout Us:ICON plc is a world-leading healthcare intelligence and clinical research organization. We're proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our...
-
Regulatory Affairs Director
2 weeks ago
Reading, Reading, United Kingdom Icon plc Full timeJob DescriptionJob Title: Regulatory Affairs DirectorJob Summary:At Icon plc, we are seeking a highly skilled Regulatory Affairs Director to join our team. As a key member of our regulatory affairs team, you will be responsible for developing and implementing regulatory strategies for our clients in the medical device industry.Key Responsibilities:Develop...
-
Account Director
2 weeks ago
Reading, Reading, United Kingdom Project People Full timeJob Summary:Project People is seeking an experienced Account Director to lead our creative projects and contribute to the success of our high-profile brands. As an Account Director, you will play a pivotal role in ensuring the smooth execution of our campaigns, managing the expectations of internal customers, and coordinating multi-disciplined teams to...
-
Regulatory Affairs Director
2 weeks ago
Reading, Reading, United Kingdom Icon plc Full timeJob SummaryWe are seeking a highly skilled Regulatory Affairs Director to join our team at Icon plc. As a key member of our organization, you will be responsible for developing and implementing regulatory strategies for our clients in the medical device industry.Key ResponsibilitiesDevelop and implement initial or alternative regulatory strategies for...
-
Account Director
3 days ago
Reading, Reading, United Kingdom Project People Full timeJob Title: Account DirectorAbout the Role:We are seeking an experienced Account Director to join our dynamic team at Project People. As an Account Director, you will play a pivotal role in the success of our creative projects, ensuring that everyone involved is clear on their roles and responsibilities.Key Responsibilities:Manage multi-channel creative...
-
Account Director
3 days ago
Reading, Reading, United Kingdom Project People Full timeJob Title: Account DirectorAbout the Role:We are seeking an experienced Account Director to join our dynamic team at Project People. As an Account Director, you will play a pivotal role in the success of our creative projects, ensuring that everyone involved is clear on their roles and responsibilities.Key Responsibilities:Manage multi-channel creative...
-
Regulatory Associate
3 months ago
Reading, United Kingdom Bayer Full time**At Bayer we’re visionaries, driven to solve the world’s toughest challenges and striving for a world where ,Health for all, Hunger for none’ is no longer a dream, but a real possibility. We’re doing it with energy, curiosity and sheer dedication, always learning from unique perspectives of those around us, expanding our thinking, growing our...
-
Executive Account Director
2 weeks ago
Reading, Reading, United Kingdom Project People Full timeAbout the RoleWe are seeking an experienced Executive Account Director to join our team at Project People. As an Account Director, you will play a pivotal role in the success of our creative projects, ensuring that everyone involved is clear on their roles and responsibilities.Key Responsibilities:Manage multi-channel creative campaigns, leveraging your...
-
Regulatory Affairs Project Manager
2 months ago
Reading, United Kingdom Pharma Partners Recruitment Ltd Full timeJob title: Regulatory Affairs Project Manager – UK/IE A Top 10 Pharmaceutical business in Berkshire are seeking a Regulatory Affairs Project Manager. This is a UK/IE affiliate role and will work across an Oncology portfolio. Responsibilities: Serves as Health Authority liaison and interfaces with Health Authorities. Lifecycle management of applicable...
-
Regulatory Affairs Project Manager
4 weeks ago
Reading, United Kingdom Pharma Partners Recruitment Ltd Full timeJob title: Regulatory Affairs Project Manager – UK/IE A Top 10 Pharmaceutical business in Berkshire are seeking a Regulatory Affairs Project Manager. This is a UK/IE affiliate role and will work across an Oncology portfolio. Responsibilities: Serves as Health Authority liaison and interfaces with Health Authorities. Lifecycle management of applicable...
Associate Director, Translations Regulatory Submissions Project Management
3 months ago
The Associate Director – Regulatory Submissions
The Associate Director – Regulatory Submissions is responsible to lead a worldwide Regulatory Submissions delivery team within IQVIA Translations. This team is in charge of the development and harmonization of the Regulatory Submissions Process. The Associate Director – Regulatory Submissions has experience working with QRDs, CTDs, SmPC, PIL, and any other regulatory materials for EMA, SwissMedic, FDA, and the rest of the world.
Responsibilities:- Lead Regulatory submission Team Leaders under his/her remit and ensure the whole team meets and exceeds their monthly and yearly goals and objectives.
- Lead and implement processes to improve efficiency and ensure high-quality deliverables for all Regulatory Submissions projects.
- Coordinate with colleagues in other departments to develop and expand on existing workflows and offerings.
- Represent IQVIA Translations in strategic RFP processes as needed for Regulatory Submissions projects.
- Act as the main point of contact for internal/external clients and manage any escalations or issues that may arise within the team.
- Liaise with the client to establish methodologies and to assess and agree project parameters and requirements.
- Prepare and implement smooth on-boarding plans for future new clients.
- Coordinate and communicate with interviewers and recruiters for the purpose of conducting debriefing interviews, analyzing results, and making recommendations for improvements.
- Collaborate with Vendor Managers to develop an extensive network of Regulatory Submissions linguists and subject matter experts.
- Monitor and manage the status of the team's projects to effectively anticipate and prevent issues.
- Ensure that the team accurately and timely complete project finances including quoting and budgeting.
- Understand and adhere to the Quality Management System.
- Comply with relevant and applicable IQVIA procedures and SOPs.
- Maintain and update SOPs when applicable.
- Work with Team Leads to help in the training and development of junior staff.
- Closely collaborate with the Quality and Compliance team to ensure the best standards are reached.
- Ensure that high quality is maintained for all projects through QA checks and comprehensive CAPA plans.
- Contribute to developing a continuous improvement culture where productivity and quality standards should be raised year by year through the usage of state-of-the-art technologies and IQVIA Lean Best Practices.
- Get trained as an IQVIA Lean Manager to be able to effectively lead/collaborate in IQVIA Lean initiatives.
- When assigned, ensure the team is closely aligned to collaborate and meet priorities defined by project PIC (Principal in Charge).
- Minimum of 5 years of experience specializing in Regulatory Submissions as a Manager, Team Leader, Director, or Associated Director in the Life sciences Language Services industry.
- Experience in leading a team of Project Managers within Regulatory Submissions.
- Bachelor’s degree, ideally in a linguistic, business, or scientific field.
- Fluency in English is essential, an additional language would be advantageous.
- Experience in Russian Regulatory submissions will be highly considered.
- Excellent written/verbal communication skills.
- Excellent attention to detail to ensure that high-quality standards are maintained.
- Ability to meet strict deadlines and to manage competing priorities and changing demands.
- Excellent problem-solving and analytical skills.
- Ability to follow instructions and work independently while using own initiative.
- Demonstration of advanced IT skills.
- Experience working with technical files, TMS and CAT tools, experience working with XTRF and/or MemoQ would be highly advantageous.
- Ability to establish and maintain effective working relationships with colleagues, managers, and clients.
IQVIA is a leading global provider of advanced analytics, technology solutions, and clinical research services to the life sciences industry. We believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. Learn more at
