Requirements: English
Company: Labiana Health
Region: Corbera de Llobregat , Catalunya
We are seeking a talented REGULATORY AFFAIRS OFFICER to join our dynamic Regulatory Affairs Team at a leading pharmaceutical company dedicated to licensing and manufacturing both human and veterinary medicinal products. Reporting to the Regulatory Affairs Manager, the key responsibilities of this role include:
- Providing regulatory advice and establishing regulatory strategies during the early stages of the company''s development.
- Compiling, writing, and reviewing Marketing Authorization applications for the company''s products across MRP, DCP, and national procedures.
- Managing eSubmissions.
- Participating in all Regulatory Affairs activities related to Life Cycle Management once products are authorized.
- Offering regulatory support to clients regarding CDMO and out-licensed products.
- Assessing regulatory impact of internal change requests.
- Contributing regulatory insights during due diligence activities.
- Conducting regulatory intelligence to advise on regulations and guidelines for both internal and external customers.
Qualifications
- University degree in pharmacy or a science related field
Experience
- Minimum of 3 years in regulatory affairs within the pharmaceutical industry
Skills
- Strong expertise on CMC
- Advanced in oral and written English
- Advanced skills in Microsoft Office and eCTD manager
- Knowledge of European pharmaceutical legislation, guidelines, procedures, and requirements
- Proactive, possessing excellent communication, scientific, and writing skills
- Team-oriented with a strong focus on customer service
Social Benefits: Health insurance, life insurance, 50% meal bonus, school bonus, etc.
Schedule: Flexible entry from 7:30am to 9:15am and departures from 4:30pm (Monday to Thursday) and Friday intensive day with departures from 3:00pm.
Salary: To be determined.