Nivel cariera

Senior (5-10 ani), Executive (>10 ani)

Limbi vorbite

engleză, română

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ProductLife Group is looking for a Hub Leader Eastern Europe in Cluj-Napoca!

 

ProductLife Group is the European industry-leading specialist service provider for the Life Sciences industry, focused on delivering high quality professional services in the areas of Regulatory, Safety, Quality, Process alignment and Medical services. All ProductLife Group’s services are targeting support for comprehensive compliance and safety throughout the product life cycle, therefore enabling continuity and productivity of product development and subsequent processes.

 

As a result of an increase in our workload we are now seeking a Hub Leader Eastern Europe responsible for Managing the regulatory affairs platform or hub.

 

We are looking for someone with proven understanding of the regulatory processes and experience in leading projects successfully, excellent organisational and interpersonal skills and the ability to work and interact smoothly within an international team. For this role we are seeking a professional with excellent communication skills in English.

 

Job Description:

  • Management of the RA platform/RA Hub team;
  • Ensures delivery of regulatory services by the platform/the Hub. Regulatory services include pre-licensing activities, new registration (sites and medicinal products), post licensing regulatory submissions, interaction with health authorities on behalf of PLG customers;
  • Serves as the senior contact for regulatory issues (backed up by regulatory colleagues with similar expertise). This includes effectively liaising with clients, project/engagement managers and internal staff.
  • Provides on-going regulatory advice to project teams: ensuring that regulatory concerns are planned/considered, and the relevant data are generated to meet project objectives.
  • Provides strategic regulatory support to clients and associate companies;
  • Secures the selection and qualification of regulatory partners to ensure an end to end regulatory service for the Regions/Countries under his/her responsibility. Responsible for the follow up of the quality of service of these regulatory partners.
  • Presales: Ensure providing technical support to presales; Ensure adequate technical description of the proposals and support sales for quotation evaluation; Review proposals
  • Ensures that invoicing is correctly set. Validate invoices.
  • In contact with IT: ensures that all the tools needed for delivering services or managing projects are in place and handled by the platform/the Hub staff;
  • In contact with Quality: ensures that all the processes and procedures, which are supporting the service delivery are set-up and read/analyzed/understood by the platform/the Hub staff;
  • Ensures that all technical information/ training material are organized and shared within the platform employees;
  • Verify data entry of the Platform/Hub employees in PLG tools. Ensures KPI, metrics for all regulatory services supplied by the platform/the hub (adequately measured and reach or exceed defined targets);
  • Responsible for monitoring and managing financial systems that provide accurate financial information to the Managing Director and Contracts & Finance Manager;
  • Producing and reviewing SOPs related to the Regulatory Affairs function;
  • Being the Regulatory expert for the Region(s) coordinated by the platform/ the Hub;
  • Providing in-house training as required for employees in the Regulatory Affairs group;
  • Possibly involved in consultancy services in case of the listed Regions/countries;
  • Could be assigned as engagement manager for BPO services;
  • Can act as regulatory business process expert for the set-up of BPO services;
  • Liaising with other group companies on regulatory issues and to provide support for their activities in the regulatory field;
  • Representing PLG in regulatory associations, events and congress;
  • Complying with the company’s policies and procedures to meet statutory, quality and business requirements within the overall strategy and objectives;
  • Budget: Responsible for managing platform budgets where applicable;
  • People: Line management to Regulatory Affairs Managers, Officers and Assistants;

 

Requirements:

  • Bachelor’s or higher graduate degree in a science related field, or equivalent experience (proven understanding of the regulatory);
  • Knowledge of EU and East European registration;
  • Minimum 8 years of professional experience in Regulatory Affairs (expert in regulatory affairs and related fields);
  • Ability to organize a service, track and measure performance;
  • Ability to co-ordinate, manage and motivate a team;
  • Good computer skills
  • Good understanding of regulatory tracking database software, eDMS, MS Word, MS Excel
  • Previous experience in team management preferred
  • Excellent organizational and interpersonal skills (written and verbal fluency);
  • Ability to work well within a team;
  • Process orientated with good attention to detail;
  • Effective oral and written communication skills (English - language and grammar)
  • Fluent in English for contact with internal and external international partners.

Benefits:

  • Full training on the job and external courses will be provided;
  • Competitive salary package;
  • Dynamic environment;
  • International and growing company;
  • Health insurance;
  • Meal tickets.