Regulatory Affairs APIs - Documentation Lead Barcelona

Descripción de la oferta

Multinational APIs manufacturer located in Barcelona is hiring Regulatory Affairs - Documentation Lead.


Descripción de la oferta

* Coordinate document management and related submission and archiving processes within the RA function
* Operate and maintain global RIM database and Submission platform for the business unit
* Compile and submit regulatory documentation to Health Authorities
* Track global distribution of regulatory documentation and certifications
* Implement and maintain best practices for regulatory information management
* Contribute and/or lead development activities and projects related to RA document management and IT systems
* Collaborate closely with international RA managers to ensure adherence to timelines for document preparation and submission


Perfil del candidato

* BSc./MSc. in a life sciences or related discipline
* Minimum of 5 years of experience in a similar position in the pharmaceutical industry
* Expert knowledge of document management systems
* Advanced knowledge using office applications (MSOffice, SharePoint, Teams)
* Hands-on experience in working with CTD and eCTD compilation and submission
* Fluent in English; additional languages are a plus
* Knowledge of regulatory affairs for API is a plus
* Highly motivated and open minded personality, keen to work in an international environment
* Excellent organizational skills, business orientation and flexibility
* Attention to detail
* Able to work well under pressure in teams and independently
* Good communication and project management skills


Oferta de empleo

A good opportunity for your professional development.* BSc./MSc. in a life sciences or related discipline
* Minimum of 5 years of experience in a similar position in the pharmaceutical industry
* Fluent in English

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