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.