Regulatory Affairs Pharmacist
MVG Recruitment Specialists
- Undisclosed
- Permanent Specialist EE position
-
Johannesburg
- Posted 29 Apr 2024 by MVG Recruitment Specialists
-
Job 2562546 - Ref MP/AD_RA
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
MVG Recruitment Specialists
About the agency
Headquartered in Cape Town.
Medical and Pharmaceutical Recruitment Specialists; Specialising in the placement of pharmacists, pharmacist assistants, nurses and technical staff into all areas of the medical/pharmaceutical industry nationally in South Africa. APSO Registered.
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