
Senior Regulatory Compliance Expert
1 week ago
Leading pharmaceutical companies require diligent professionals to ensure compliance with regulatory frameworks.
We are seeking a seasoned Regulatory Affairs Specialist to join our team. This role involves ensuring the company's diverse product portfolio adheres to global regulatory standards.
Job Description:- Key Responsibilities:
- Ensure products comply with all relevant regulations and standards.
- Demonstrate knowledge and execution of Type IA, IB, and II Variations.
- Manage licence transfers in various international territories.
- Review promotional material for medicinal products.
- Prepare Module 1 documentation for National Applications.
- Participate in meetings with Regulatory Authorities.
- Deal with regulatory aspects of internationalising products and applying for reclassification.
- Train and mentor junior team members on Regulatory processes and compliance requirements.
- Maintain awareness of regulatory trends and changes relevant to the industry.
- Essential Experience & Knowledge:
- 3-4 years progressive experience in Regulatory Affairs within the pharmaceutical industry.
- Demonstrable experience with pharmaceutical products, specifically OTC and/or prescription medicines.
- Exceptional attention to detail and organisational skills.
- Able to work independently and take responsibility for actions.
- Competitive Package:
- Highly competitive salary.
- Performance-based bonuses.
- Flexible working arrangements.
- Significant opportunities for career advancement.
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