Overview Our client is looking for a Regulatory Affairs Pharmacist. This role is responsible for ensuring that the company's products comply with all applicable regulatory requirements. This includes reviewing and drafting regulatory submissions, providing advice to product development teams, and managing regulatory relationships. The ideal candidate will have a strong understanding of pharmaceut...
At Elanco (NYSE: ELAN) it all starts with animals!As a global leader in animal health, we are dedicated to innovation and delivering products and services to prevent and treat disease in farm animals and pets. We're driven by our vision of 'Food and Companionship Enriching Life' and our approach to sustainability the Elanco Healthy Purpose to advance the health of animals, people, the planet and ...
SKILLS & QUALIFICATIONS:Bachelors degree in Pharmacy, registered with the South African Pharmacy CouncilMSc, MBA or PhD may be an advantage.Experience in regulatory affairs, preferably in human medicines - minimum 8 years of experience.Key Knowledge and Skills required:Experience in registration of products and regulatory knowledge on South Africa, Botswana and Namibia market guidelines.Demonstra...
SKILLS & QUALIFICATIONS: Bachelors degree in Pharmacy, registered with the South African Pharmacy Council MSc, MBA or PhD may be an advantage. Experience in regulatory affairs, preferably in human medicines - minimum 8 years of experience. Key Knowledge and Skills required: Experience in registration of products and regulatory knowledge on South Africa, Botswana and Namibia market guidelines. Dem...
Position Summary and Objective:Responsible for the regulatory management of South Africa and some Southern African markets like Botswana and Namibia for an allocated part of the companys generic portfolio of products. Future markets and portfolios of products could be included as well as regulatory harmonization occurs.Provide oversight for assigned countries for the portfolio and strategic initi...
JOB OVERVIEW: Ensuring thorough, seamless product registration process and dossier maintenance. Ensuring that the company complies with all regulations and maintain comapanys pharmacovigilance requirements. DUTIES AND RESPONSIBILITIES: Provide, Lead, manage, and execute strategic direction as the regulatory affairs pharmacist Ensure and supervise that regulatory documentation meets relevant regul...
Job Purpose: To assist and maintain aspects of the Quality Management System, adhering to SA GMP requirements and those of the Office of Global Quality. To assist with Pharmaceutical Quality System elements (Quality Complaints Investigations, PQR s, Quality Risk Management) To review and authorize Non-conformance Reports, Change Controls and complete Master Batch Documentation Review. Main Duties...
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