Regulatory Affairs APIs - Documentation Lead

• Multinational APIs manufacturer in Barcelona
• RA with minimum 3 years of experience

Leading antibiotics manufacturer, who produce and sell intermediates, APIs and finished dosage forms. Headquartered in Europe, they have manufacturing sites and sales offices in Asia, North Africa, Europe, North America and LATAM.

• 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

A good opportunity for your professional development

• BSc./MSc. in a life sciences or related discipline


• Minimum of 3 years of experience in a similar position in the pharmaceutical industry


• Fluent in English; additional languages are a plus


• 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


• 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