Job Description

A global generic pharmaceutical company is looking for a Regulatory Affairs Pharmacist.
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 with internal stakeholders effectively and provide required regulatory support
• Keeping abreast of developments and changes in the local regulatory environment which directly impacts on the product brands.
• Pre and post submissions amendments
• Regular engagement with SAPHRA and meetings and and when required
• Assisting within the Quality Assurance Department when required

Minimum Requirements

• Bachelor of Pharmacy degree is essential
• Registered with the SAPC
• Minimum of 5 years Regulatory Affairs experience in pharmaceutical industry.
• QA experience would be an advantage
• Excellent spoken and written English.
• 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.

Candidates that meet the criteria may submit their applications via this portal or via vacancy link on www.mnarecruitment.com
Should you receive no feedback within 7 days, please accept your application as unsuccessful.

Skills Required