Senior Regulatory Affairs Pharmacist Complimentary Medicine - Midrand - Emporium Human Capital

Description

Senior Regulatory Affairs Pharmacist - Complementary Medicine

We are seeking a highly experienced and skilled Senior Regulatory Affairs Pharmacist to lead our regulatory affairs team in the development and implementation of regulatory strategies for complementary medicines.

Key Responsibilities:

• Manage work streams for assigned portfolio of products, including internal and external product queries, regulatory priorities, resource allocation, and workload management.
• Review regulatory agency submissions to ensure accuracy, comprehensiveness, and compliance with regulatory standards.
• Develop and implement regulatory strategies for new product applications, focusing on complementary medicines and medical devices.
• Conduct dossier due diligence to address data gaps, prepare registration applications, and submit to regulatory authorities.
• Maintain existing registrations, update databases, and ensure compliance with relevant legislation, regulations, and guidelines.
• Establish and maintain relationships with regulatory authorities, internal stakeholders, and external partners.
• Formulate and implement regulatory affairs systems, policies, and procedures to ensure compliance and enhance regulatory performance.

Requirements:

• Bachelor's Degree in Pharmacy, Diploma in Pharmacy, and Registration with the South African Pharmacy Council.
• Minimum 5 years of experience in Regulatory Affairs, preferably in human medicines, including complementary medicines and medical devices.
• Demonstrable experience across the product development, commercialization, and maintenance lifecycle.
• Sound project management capabilities, proven ability to deliver quality results under tight deadlines, and good understanding of Good Manufacturing Practices (GMP).
• Pharmaceutical production experience or exposure to supplement regulatory knowledge.
• Excellent IT skills, including Microsoft Office, and ability to use CTD software builder and compile eCTD dossier applications.
• Strong analytical and problem-solving skills, ability to prioritize tasks, and excellent communication and interpersonal skills.

About Us:

We are a leading company in the pharmaceutical industry, committed to delivering high-quality products and services. We offer a dynamic and challenging work environment, opportunities for professional growth and development, and a competitive salary package.