
Regulatory Compliance Specialist
1 day ago
We are seeking an experienced Regulatory Affairs (Pre-Approval) Supervisor to oversee regulatory strategy and documentation requirements.
- Key Responsibilities:
- Act as a responsible Regulatory Team member for assigned projects, ensuring timely completion of regulatory documentation for DCP, MRP and National applications.
- Candidate will coach, guide and review deliverables of Regulatory Affairs Officers and Associates, maintaining high standards of quality and compliance.
- Liaise with external Regulatory authorities as required, ensuring policies and procedures are properly understood and carried out.
- Support internal activities of the Regulatory department to ensure regulatory compliance of registered products.
- Compile and monitor the progress of scientific responses to deficiencies raised by Regulatory authorities.
Requirements
- A BSc Degree in Pharmacy, Biology or a relevant field is required.
- The ideal candidate should have 5+ years of experience in Regulatory within a Pharmaceutical organization, demonstrating a strong understanding of EU regulatory guidelines.
- Fluent English language skills and excellent MS Office proficiency are essential.
- Candidates must possess strong organizational skills, be able to multi-task and meet deadlines while effectively communicating and managing relationships.
What We Offer
We provide a competitive salary and benefits package, along with continuous specialized training and career development opportunities. Our friendly working environment fosters growth and collaboration among our team members.
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