Senior Regulatory Affairs Specialist

hace 3 semanas

Barcelona, España Westerman A tiempo completo
Westerman is a leading firm of high-value intelligent solutions in the area of executive search whose work philosophy is based on the combination of the boutique model of international headhunting with a strong digital approach based on e-searching.

We collaborate with a company in the pharmaceutical sector with an international presence in the search for an EMEA Regulatory Affairs Specialist.

The main functions to be developed are:

  • Ensure compliance with all the relevant regulatory, pharmacovigilance and quality requirements in Europe

  • Implement the Regulatory submission strategy in Europe, with a focus on the B2C activities (direct sales in the market)

  • Support the new product submissions  in Europe, primarily via DCP, and co-ordinate the national phase

  • Support the maintenance of granted marketing authorizations and co-ordinate variations

  • Liaise with the Global RA, QA and Pharmacovigilance function

  • Support the BD function and interact and resolve any Technical Issues with our Customers

  • Support the activities of the Qualified Person for Pharmacovigilance (QPPV) and the maintenance of the European pharmacovigilance system, including the population and maintenance of the EMA Article 57 database (xEVMPD):

  • Support QA-related activities that are required for the running of the business in Europe such as the maintenance of WDL/MIA licences in Europe, and the establishment of Quality agreements

  • Support the method transfer and batch release process in Europe, and ensure co-ordination with the manufacturing sites

  • Liaise with European Health Authorities

  • Represent the company and the department during interactions with clients, providers and consultants

  • Propose and implement new standard operation procedures

  • Keep up-to-date with the current EU legislative guidelines



Requisitos

  • At least 5 years´ work experience in a Regulatory Affairs department with significant involvement in EU procedures and, preferably, with exposure to Pharmacovigilance and Quality Assurance & compliance 

  • Science Degree and preferably a post-graduate Master in Industrial pharmacy

  • Excellent written and verbal communication skills. Fluent in English and Spanish, a 3rd European language is a plus

  • Strong communication skills and IT fluency; proficient in Word, Excel and Outlook

  • Ability to manage complex projects and multi-task

  • Excellent organizational skills

  • Ability to flourish with minimal guidance, be proactive, and handle uncertainty

  • Comfortable using a computer for various tasks

  • Being Professional & punctual, well-organised

  • Team Player.



Ventajas
  • You will join a great project in expansion of a pharmaceutical company with a strong international presence.
  • You will develop a profile with European scope and in collaboration with the different international departments of the company.
  • Competitive salary
  • Hybrid and flexible working mode


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