Oferta pracy

Reg Specialist, Submission Coordination

GSKAbout the company

  • Poznań

    Poznań, Greater Poland
  • Offer expired a month ago
  • Remote recruitment
  • contract of employment
  • full-time
  • specialist (Mid / Regular)

Your responsibilities

  • Accountable for delivery of submissions or strategy components for an assigned product in development or marketed product to agreed timeframes and appropriate content

  • Works closely and effectively with contributing functions to deliver submissions on time, escalate risks associated with submissions components delivery.

  • Ensures quality of both own and submission team work and compliance with regulatory guidelines and process as they apply to the role.

  • Works with staff from other functions, and should be capable of working to senior levels in development functions in provision of advice, interpretation of relevant guidances, researching topics and resolving issues.

  • May be required to liaise with Regulatory Agencies to resolve issues in relation to their accountabilities.

  • May be responsible for the maintenance activities associated with an approved product, including product renewals, site renewals, site registrations, variations, label harmonization, PBRER submissions etc

  • Plans, communicates and executes activities with minimal input from manager

Our requirements

  • Relevant experience (in regulatory affairs, pharmaceutical industry, life sciences research, clinical research, pharmacovigilance)

  • Bachelor’s or Master's degree in biotechnology, pharmacy, chemistry or other related science or technical field

  • Excellent organisational skills, attention to detail and commitment to deliver high quality output, even under pressures sometimes demanded by regulatory deadlines

  • Excellent written and verbal communication skills in English and Polish, ability to present information in a clear and concise manner

  • Ability to think flexibly to meet constantly shifting priorities and timelines and to independently provide solutions to issues

  • Understanding of the pharmaceutical industry, drug development environment, and regulatory processes

  • Knowledge of drug development and manufacturing and supply processes.

  • Knowledge of worldwide CMC regulatory requirements

  • Experience within Regulatory Affairs in the Drug development and Post Approval environment

  • Experience with project management to coordinate submission components

  • Global/ EMAP Regulatory submission experience - knowledge of regulatory agency guidelines as an asset

What we offer

  • Important and interesting job in one of the leading global healthcare companies.

  • Possibility to work with engaged and enthusiastic people from various locations.

  • Access to newest technologies and solutions.

  • Possibilities of development within the role and company’s structure.

  • Benefits (e.g. private medical healthcare, life insurance, sports card, pension plan, flexible working hours, home office).

  • Corporate culture based on our values: patient focus, integrity, respect and transparency.

  • Benefits

  • retirement pension plan

  • leisure zone

  • extra social benefits

  • holiday funds

  • charity initiatives

  • one shorter working day

  • life Insurance

  • sport and recreation cards

  • annual bonus

  • canteen for employees at site (with discounts)

  • flexible working options available for most positions

GSK

Content Delivery in Global Regulatory Affairs at GlaxoSmithKline is a regulatory affairs function which brings together the operation, execution and delivery aspects for key regulatory deliverables such as new chemical entity and product expansion dossiers, labelling outputs, license maintenance and lifecycle management dossiers. Content Delivery provides regulatory support across the product lifecycle for pharmaceutical products (clinical development to market maturity).

Step up to the new challenge and take the lead in a diverse international regulatory environment. Bring a real value to our Patients worldwide by having a high level of impact on delivery of the early and late-stage pipeline.

As a Submission Coordinator, you will work closely with project lead, global regulatory lead and local operating companies in regards to requirements, deliverables and timelines for EU as well as emerging market submissions in which GSK does business and ensure applications and dossiers are prepared in compliance with Regulatory Authority regulations and guidance’s and with GSK SOPs and working practices. The job holder will work on global submission teams to manage regulatory submissions from submission through to approval, ensuring that applications and dossiers are prepared to the highest quality standard and in a timely efficient manner. The job holder will utilize in-depth knowledge of global regulatory submission requirements, processes and procedures, eCTD structure/format, associated GSK systems and ensure teams meet with target submission dates. Supports project lead with requesting the administrative requirements for different countries, efficient hand-offs to publishing team for all modules and life cycle maintenance activities for EU product license like PBRER, PIP, renewals etc. and for emerging markets. Proactively work with team and try reduce “rework” to avoid time delays, while at the same time ensuring all necessary quality reviews and approvals are achieved, allowing GSK to continue producing applications to the highest quality standard.

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