Descrição da Função

Your new Company

Join a multinational company in the Pharmaceutical Industry. 

Your new role

Reporting to the Regulatory Affairs Manager, your main responsibilities will be:
Support timely preparation, submission and follow up of new MA applications to the local NCAs and support the maintenance of authorised medicinal products through timely preparation and/or submission of variations, renewals or PSURs
Ensure compliance with the company policies and relevant regional and local regulations
Reviewing promotional and non-promotional materials
Support the collection of relevant public available regulatory information
To act as *backup* Responsible Person as defined in EU GDP Guideline 2013/C 343/01
Support quality assurance activities (eg. deviations, CAPAs, change control, product quality complaints)
Support the implementation and maintenance of a Quality Management System, which is compliant with EU GDP Guidelines, local legislation and company quality assurance requirements 

What do you need to be successful

MS Degree in Pharmaceutical Sciences (preferred) or other Life Science
1 to 3 years of experience in Regulatory Affairs and/or Quality Assurance within a pharmaceutical company
Advanced knowledge of Portuguese and English.
We are looking for a dynamic individual with good communication skills and adaptability. 

What the company can offer you 

We offer a 12-month Temporary Contract where you can continue to develop your expertise in regulatory and quality areas. 
Base salary of €1500 gross/month, Meal Allowance and Computer. (Could be Negociable) 
Full-time position (40 hours/week)
Hybrid work model: 2 days per week in the office 
Start date: October.

Licence 354

Next Steps

If you are interested in this job, please send us your updated CV.

Contacto

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