
Strategic Regulatory Compliance Specialist
2 days ago
We are seeking a highly skilled Regulatory Affairs Supervisor to oversee regulatory projects and ensure compliance with regulatory requirements.
Key Responsibilities:
- Develop and implement regulatory strategies to support business objectives
- Manage regulatory documentation, including DCP, MRP, and national applications
- Coach and guide Regulatory Affairs Officers and Associates on regulatory deliverables
- Liaise with external regulatory authorities and internal departments to collect necessary information and documentation
- Compile and monitor the progress of scientific responses to deficiencies raised by regulatory authorities
Requirements:
- Bachelor's degree in Pharmacy, Biology, or relevant field
- At least 5 years of experience in Regulatory Affairs within a Pharmaceutical organization
- Fluent English language skills and good MS Office skills
- Strong organizational skills, multitasking, and ability to meet deadlines
- Effective communication and relationship management
- Knowledge of EU regulatory guidelines
- Ability to work under pressure and maintain resilience
Benefits:
- Competitive salary and benefits package
- Ongoing specialized training and career development opportunities
- Friendly working environment
Why this role is important:
This role plays a critical part in ensuring our products comply with regulatory requirements. The successful candidate will have excellent leadership and communication skills, as well as the ability to navigate complex regulatory frameworks.
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