Job Description:
We are seeking an experienced Regulatory Affairs Manager to join our team. The primary purpose of this position is to manage regulatory regional operational activities in the EU markets to maintain regulatory compliance of iNova's products.
About the Role:
* Coordinate and/or execute the regulatory operational activities related to new marketing authorizations and lifecycle submissions across the region.
* Ensure labelling maintenance and compliance and support the translation process as required.
* Maintain compliance for all marketing authorisations in Europe, including those held by third parties on behalf of iNova.
* Ensure efficient and consistent implementation and use of internal and external regulatory databases and systems.
Requirements:
* A recognised pharmacy (preferred), medical or relevant science university degree with a minimum of 4-5 years' experience in the pharmaceutical industry.
* At least 3 years' experience in European (EU) countries and good pharmacological/ pharmaceutical/ clinical knowledge.
* Solid understanding of regulatory requirements for medicines, medical devices, and complementary medicines.
* Strong knowledge of global regulatory frameworks (MRP, DCP, CP).
* Familiar with fundamental principles of clinical, regulatory, registration and compliance issues in the EU region.
Benefits:
This is an excellent opportunity to work in a dynamic environment with a leading health company. You will have the chance to develop your skills and expertise in regulatory affairs and contribute to the success of our business.
About Us:
iNova is a different kind of health company that leads the way to better health by delivering innovative, patient-centric products that improve the lives of people around the world.