Regulatory Affairs Officer

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:

1. Providing regulatory advice and establishing regulatory strategies during the early stages of the company's development.
2. Compiling, writing, and reviewing Marketing Authorization applications for the company's products across MRP, DCP, and national procedures.
3. Managing eSubmissions.
4. Participating in all Regulatory Affairs activities related to Life Cycle Management once products are authorized.
5. Offering regulatory support to clients regarding CDMO and out-licensed products.
6. Assessing regulatory impact of internal change requests.
7. Contributing regulatory insights during due diligence activities.
8. Conducting regulatory intelligence to advise on regulations and guidelines for both internal and external customers.

Qualifications:

1. University degree in pharmacy or a science related field.
2. Minimum of 3 years in regulatory affairs within the pharmaceutical industry.
3. Strong expertise on CMC.
4. Advanced in oral and written English.
5. Advanced skills in Microsoft Office and eCTD manager.
6. Knowledge of European pharmaceutical legislation, guidelines, procedures, and requirements.
7. Proactive, possessing excellent communication, scientific, and writing skills.
8. 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.

Location: Regulatory • Valencia, Kingdom Of Spain, ES