Regulatory Affairs Pharmacist

About the position

Large pharmaceutical manufacturing facility seeks to employ a Regulatory Affairs Pharmacist. The following applies:

Key Responsibilities:

• Ensure timeous initiation and management of the registration process for new product submissions
• Ensure approval of registration applications of all medicines with the relevant authorities
• Ensures that all assigned dossiers are submitted timeously to relevant health authorities and are followed up on regularly in order to enable registrations
• Manages relationships with the Regulatory Authorities to ensure more effective streamlining of the company's applications when required
• Effectively managing, auditing and implementation of Regulatory systems
• Prepare, review and adhere to Standard Operating Procedures (SOP's) and local Regulatory Guidelines

Key Requirements:

• Bachelor's degree in Pharmacy and registered with the South African Pharmacy Council
• 2-5 years' experience in Regulatory Affairs, preferably in orthodox, human medicines
• Demonstrable experience across the product development, commercialization, and life-cycle maintenance.
• Knowledge of new and emerging Acts, Regulations and Guidelines pertaining to the pharmaceutical industry.
• Experience in use of CTD software builder and compilation of eCTD application will be an advantage such as docuBridge.

Key Competencies

• Knowledge of the Regulatory requirements for medical products in South Africa and other applicable territories.
• Project management and leadership skills
• Ability to prioritise and work to tight deadlines
• Cross Functional skills: Ability to network, liaise and negotiate with others

(Full role profile available on application)

Apply to [Email Address Removed] Subject: MP/AD_RA

Supporting documentation required:

• Comprehensive CV
• Copy of Matric Certificate
• Copy of Pharmacy Degree

Desired Skills:

• 2-5 years' experience in Regulatory Affairs
• preferably in orthodox
• human medicines

Desired Qualification Level & Accreditations:

• Degree
• South African Pharmacy Council