Regulatory Affairs Pharmacist

SUMMARY:
Client based in Northriding is looking for a Regulatory Affairs Pharmacist

POSITION INFO:

Only candidates that for the following criteria will be contacted :
Responsibilities:
Compile and submit new product applications and ensure that the registration requirements are fulfilled so that the registration process and approval can be obtained as soon as possible.

• Monitor and follow up on the progress of submissions.
• Activities relating to product lifecycle management.
• Maintain and develop working relationships effectively and provide required regulatory support.
• Reviewing artwork relating to products ensuring that it is in compliance with all legal requirements.
• Checking Format and Content Compliance with latest codes of conduct and regulations.
• Keeping abreast of developments and changes in the local regulatory environment which directly impacts on the product brands.

• Registration with the South African Pharmacy Council (SAPC) is essential
• Minimum of 2-4 years Regulatory Affairs experience in pharmaceutical industry.
• Experience working with SAHPRA and other Regulatory Authorities in Africa. 
• Excellent spoken and written English.
• Experience submitting eCTD – good computer literacy skills also required.
• Hard working – able to multi task and manage multiple projects simultaneously.
• Strong communication skills – experience in liaising with Business Managers, Quality Assurance & Marketing departments
• Knowledge of Acts, Regulations and guidelines pertaining to the Pharmaceutical Industry.
• In-depth knowledge of regulatory requirements.
• Understanding of regulatory compliance and the impact this can have on the business.
• Good Understanding of Quality Management Systems, SAHPRA Guidelines and Policies, Medicines and Related substances and regulations, GMP and any other QA/RA related guidelines.

NB! This job is now closed. You can apply for other jobs by uploading your CV.