Job Reference 14385
Job type Contract, Permanent
Location Citywest
Salary € Negotiable

The Role

Location: Citywest

Maternity Cover Contract - 12 Months

Flexible working hours available

Duties: 

  • Ensure timely preparation and compilation of registration dossier in accordance with EU or relevant Health Authority standards and corporate requirements;
  • Manage international regulatory submissions according to company strategy and ensure registration deadlines are met;
  • Respond to Health Authorities’ queries and deficiencies in a timely manner;
  • Liaise with other departments to support the timely introduction of new products into markets;
  • Work as part of a team dealing with global registrations and providing regulatory support to all operational departments within the company;
  • Maintain assigned products' Marketing Authorisations via submission of the appropriate variations and renewals in a timely manner;
  • Communicate Health Authority approvals/final decisions to the relevant departments;
  • Build departmental awareness of local regulatory requirements in global markets;
  • Assess the impact on existing files when new regulatory requirements are issued;
  • Archive the registration documentation according to internal standards; introduce and regularly update the internal RA database;
  • Perform assigned tasks to the highest standard and in accordance with established internal timelines and guidelines.

The Person

  • Life sciences (BSc in Chemistry/ Biology, etc.) or pharmacy degree
  • Min 4-5 year experience in a regulatory affairs environment
  • Min 4-5 year experience in the pharmaceutical industry
  • Detailed knowledge of EU and other regions current registration requirements for dossier preparation and procedure running
  • Solid knowledge of specific national requirements in EU and other regions
  • Knowledge of IT tools specific for in RA and pharmaceutical sector (e.g. eCTD, databases, change control management etc.)
  • Results and performance driven – deliver results that meet or exceed expectations
  • Sense of urgency – responding to issues and opportunities in a timely manner
  • Intellectual curiosity – willing to suggest and try new ideas
  • Positive and pro-active approach to business tasks
  • Excellent interpersonal and communications skills.
  • A solutions provider with strong multi-tasking abilities
  • Manage evolving deadlines effectively with regular feedback and updates.
  • Enthusiasm and Drive to take ownership and drive process initiatives.

Apply Now






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