Regulatory Affairs Specialist
2 weeks ago
At Jordan HR, we are seeking a skilled Regulatory Affairs Specialist to join our team. As a key member of our regulatory team, you will be responsible for ensuring the compliance of our pharmaceutical products with regulatory requirements.
This role involves extensive experience in regulatory affairs, preferably in human medicines, including complementary medicines and medical devices for end-to-end regulatory activities. You will have a strong understanding of Good Manufacturing Practices (GMP) and pharmaceutical production experience or exposure to supplement regulatory knowledge.
Key responsibilities include:
Compiling and submitting regulatory documents, including CTD software builder and eCTD dossier applications
Collaborating with cross-functional teams to ensure regulatory compliance
Providing expert advice on regulatory matters and identifying areas for process improvement
Staying up-to-date with changes in regulatory requirements and implementing updates to our processes and procedures
Requirements:
Bachelor of Pharmacy degree and registration with the South African Pharmacy Council
5+ years of experience in regulatory affairs, preferably in human medicines
Strong knowledge of CTD software builder and eCTD dossier applications
Excellent communication and problem-solving skills
Ability to work in a fast-paced environment and meet deadlines
What We Offer:
A competitive salary and benefits package
Ongoing training and development opportunities
A collaborative and dynamic work environment
The opportunity to work on high-profile projects and make a meaningful contribution to our organization
We are looking for a highly motivated and experienced Regulatory Affairs Specialist to join our team. If you are passionate about regulatory affairs and have a strong understanding of the pharmaceutical industry, we encourage you to apply.
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