Associate Director, Translations Regulatory Submissions Project Management

7 months ago

Reading, United Kingdom IQVIA Full time

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 rest of the world.
 

• Lead Regulatory submission Team Leaders under his/her remit and ensure the whole team meets and exceed their monthly and yearly goals and objectives
• Lead and implement processes to improve efficiency and to 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 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, analysing 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 teams’ 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 collaborates to Quality and Compliance team to ensure best standards are reach.
• Ensure that high quality is maintained for all projects through QA checks and comprehensive CAPA plans 
• Contribute to develop a continues 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 IQVIA Lean Manager to be able to effectively lead/Collaborate in IQVIA Lean initiatives
• When assigned, ensures the team is closely aligned to collaborate and meet priorities defined by project PIC (Principal in Charge)
 

Requirements: 

• 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 whilst 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

  • Regulatory Project Manager

    2 days ago

    Reading, Reading, United Kingdom Iqvia Full time

    Job DescriptionWe are seeking a highly experienced Associate Regulatory Project Director to lead our worldwide Regulatory Submissions delivery team within IQVIA Translations. This team is responsible for the development and harmonization of the Regulatory Submissions Process. The successful candidate will have extensive experience working with QRDs, CTDs,...

  • Submissions Process Lead

    2 days ago

    Reading, Reading, United Kingdom Iqvia Full time

    Job SummaryIQVIA Translations is seeking an experienced Associate Regulatory Project Director to lead our Regulatory Submissions delivery team. The ideal candidate will have extensive knowledge of regulatory materials, including QRDs, CTDs, SmPC, PIL, and others, and experience working with global regulatory authorities like EMA, SwissMedic, and...

  • Director of Regulatory Operations

    2 days ago

    Reading, Reading, United Kingdom Iqvia Full time

    About the RoleThis position requires a skilled Associate Regulatory Project Director to oversee our Regulatory Submissions delivery team at IQVIA Translations. The ideal candidate will have expertise in QRDs, CTDs, SmPC, PIL, and other regulatory materials for major regulatory authorities worldwide.Main DutiesOversee the performance of Regulatory submission...

  • Regulatory Project Director

    6 days ago

    Reading, Reading, United Kingdom Iqvia Full time

    Job TitleA talented Associate Regulatory Project Director is required to lead our global Regulatory Submissions delivery team.

  • Director of Regulatory Operations

    6 days ago

    Reading, Reading, United Kingdom Iqvia Full time

    Key ResponsibilitiesLead Regulatory submission Team Leaders under their remit and ensure the whole team meets and exceeds monthly and yearly goals and objectives.Implement processes to improve efficiency and deliver high-quality results for all Regulatory Submissions projects.Represent IQVIA in strategic RFP processes as needed for Regulatory Submissions...

  • Regulatory Affairs Project Manager

    5 days ago

    Reading, Reading, United Kingdom Pharma Partners Recruitment Ltd Full time

    Job Title: Regulatory Affairs Project Manager – UK/IEA leading pharmaceutical business in the UK is seeking a highly experienced Regulatory Affairs Project Manager to join their team. This role will be responsible for managing clinical trials and regulatory submissions across an Oncology portfolio.Responsibilities:Serve as the liaison with Health...

  • Regulatory Affairs Project Manager

    2 weeks ago

    Reading, United Kingdom Pharma Partners Recruitment Ltd Full time

    Job Description Job 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...

  • Regulatory Affairs Project Manager

    2 weeks ago

    Reading, United Kingdom Pharma Partners Recruitment Ltd Full time

    Job DescriptionJob title: Regulatory Affairs Project Manager – UK/IEA 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...

  • Regulatory Affairs Project Lead

    4 days ago

    Reading, Reading, United Kingdom Pharma Partners Recruitment Ltd Full time

    Job Title:Regulatory Affairs Project ManagerOverview:We are seeking an experienced Regulatory Affairs Project Manager to join our Oncology portfolio in the UK/IE affiliate. This role will involve serving as Health Authority liaison and interfacing with Health Authorities, managing Clinical Trial activities with the MHRA, reviewing promotional materials for...

  • Healthcare Regulatory Affairs Coordinator

    4 weeks ago

    Reading, Reading, United Kingdom ICON plc Full time

    Your ProfileTo succeed in this role, you will need to be an organized and detail-oriented individual with excellent communication and project management skills. A Bachelor's Degree in Life Sciences or related field is required, along with a minimum of 2 years' experience in clinical trial operations.As a Study Start-Up Associate Manager, you will be...

  • Regulatory Affairs Project Manager

    2 weeks ago

    Reading, United Kingdom Pharma Partners Recruitment Ltd Full time

    Job 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...

  • Associate Project Director

    2 weeks ago

    Reading, United Kingdom Stonor Recruitment Full time

    Job Description Associate Project Director, Operations Highly competitive salary + bonus Hybrid working (2 days in the office) Are you a Senior Project Manager or Associate Project Director and looking to take the next step?About the Role As an Associate Director, you will play a pivotal role in helping to lead the agency's operations team, driving...

  • Associate Director Regulatory Affairs Leader

    6 days ago

    Reading, Reading, United Kingdom Iqvia Full time

    About the RoleThis exciting opportunity involves leading a worldwide Regulatory Submissions delivery team, ensuring the development and harmonization of the Regulatory Submissions Process. The successful candidate will have experience working with QRDs, CTDs, SmPC, PIL, and other regulatory materials for EMA, SwissMedic, FDA, and globally.

  • Regulatory Affairs Project Manager

    2 months ago

    Reading, United Kingdom Pharma Partners Recruitment Ltd Full time

    Job Description Job 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...

  • Regulatory Affairs Project Manager

    4 months ago

    Reading, United Kingdom Pharma Partners Recruitment Ltd Full time

    Job 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

    5 months ago

    Reading, United Kingdom Pharma Partners Recruitment Ltd Full time

    Job 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 months ago

    Reading, United Kingdom Pharma Partners Recruitment Ltd Full time

    Job 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 Lead

    5 days ago

    Reading, Reading, United Kingdom Pharma Partners Recruitment Ltd Full time

    Job OverviewA Top 10 Pharmaceutical business in the UK is seeking a Regulatory Affairs Project Manager to work across an Oncology portfolio.This role will serve as Health Authority liaison and interface with Health Authorities, ensuring submission and content of new Marketing Authorisations, variations and other regulatory submissions are made in accordance...

  • Medical Devices Regulatory Project Manager

    4 months ago

    Reading, Berkshire, United Kingdom Pharma Partners Recruitment Ltd Full time

    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. Lifecycle management of applicable products and management of Clinical Trial activities with the MHRA. Reviews promotional,...

  • Medical Devices Regulatory Project Manager

    2 weeks ago

    Reading, Berkshire, United Kingdom Pharma Partners Recruitment Ltd Full time

    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. Lifecycle management of applicable products and management of Clinical Trial activities with the MHRA. Reviews promotional,...