Regulatory Affairs specialist At Sabaa Pharma
Sabaa Pharma is hiring!
We are looking for Regulatory Affairs specialists to join our team.
Duties & Responsibilities:
-Obtain marketing authorizations and appropriate legal approvals.
-Maintain licenses for existing products.
-Prepare submission documents for new product registrations, renewals, and variations.
-Preparation of responses to requests by the Authority during the evaluation process, and timely handling of deficiency letters within the specific timeframe.
Maintain a full up-to-date database and archiving system for tracking Regulatory dossiers.
-Ensure effective communication with the Regulatory Authority.
-Ensure company compliance with regulatory regulations.
-Follow up and implement any updates on the regulatory regulations and guidelines, keeping all relevant stakeholders timely and pro-actively updated.
-Effective communication and cross-functional interaction with all involved departments, both on a Regional and Central level (Regulatory Affairs, Quality Assurance, Quality Control, Production, Supply chain, Sales and Marketing and Pharmacovigilance) to facilitate and develop effective collaboration on all regulatory interactions.
Bachelor’s degree in pharmacy. Or a relevant field.
At least 2-3 years professional experience in Regulatory Affairs.
Good understanding of Regulations.
High English proficiency.
High organizational and communication skills
If you fit the above criteria, we would have the pleasure to receive your CV on firstname.lastname@example.org mentioning the job in the email subject.