POSITION TITLE:
Regulatory Affairs Pharmacist/Specialist
JOB FAMILY:
Contract position
DIVISION:
Regulatory Affairs
LOCATION:
Sandton
REPORTS TO POSITION TITLE:
Head of Regulatory Affairs Southern and South Africa
POSITION SUMMARY
Support the local and regional regulatory organization in the development, execution and implementation of
country-specific regulatory strategies to support the approval and registration of clinical trial applications, new
products, line extensions, major variations and lifecycle management.
POSITION RESPONSIBILITIES
- Develop strong cross-functional partnerships with in-country and above-country colleagues to effectively execute registration strategies for new and existing product portfolios.
- Responsible for developing, enhancing and managing relationships with regulatory health authorities (HAs) and Boards of Health (BoHs).
- Understand local regulations and developing trends in the local regulatory environment. Leverage regulatory knowledge to anticipate barriers and recommend alternative approaches in line with local policies and procedures.
- Liaise with clinical research project managers to seek to understand clinical research programmes as required.
- In partnership with above-country operational hubs, above-country WSR strategists, and local clinical operations or third party vendors, prepare agreed CTA submission documentation for both initial application and subsequent amendments, and other maintenance activities for the lifecycle of the CTA including response to Regulatory Authority queries as required.
- Ensure timely communication of any GCP breaches, or actions taken for safety reasons as required.
- Compile and submit clinical trial applications, new product applications, generic applications, new indication or line extension applications to the relevant HA’s/BoHs, ensuring that registration requirements are fulfilled.
- Responsible for the co-ordination of regulatory activities associated with product approval, including the development and submission of responses to HA queries and requests, and monitoring and following-up on progress of regulatory submissions at the HA.
- Maintain licenses (e.g. Marketing Authorizations) in compliance with local regulations and ensuring that corporate regulatory processes, SOP’s and systems are followed.
- Maintain compliance in company-specific regulatory systems and databases.
- Maintain compliance of local product artwork and promotional materials in line with local legislation, regulations and company standards
- Represent the regulatory team at cross-functional team meetings.
- Where required, represent company at the relevant industry trade association meetings.
EDUCATION AND EXPERIENCE - Bachelor’s degree in Pharmacy/Diploma in Pharmacy
- Minimum of 2 – 3 years’ experience in Regulatory Affairs, preferably in human medicines
- Demonstrable experience across the product development, commercialization and maintenance lifecycle
- Proven ability to manage complex regulatory issues
- Proven ability to consistently deliver to time, cost and quality standards
TECHNICAL SKILLS REQUIREMENTS
Technical skills required and/or preferred, as applicable.- In-depth knowledge of new and emerging Acts, Regulations and guidelines pertaining to the pharmaceutical industry.- Knowledge of clinical trial methodologies ICH/GCP, FDA and local country regulations whilst useful is not critical.- Knowledge of clinical trial and regulatory requirements as pertaining to human medicines as required.- Knowledge of the Marketing Code of Practice
Desired Skills:
- Clinical trial methodologies
- ICH/GCP
- FDA
- knowledge of clinical trial and regulatory requirement as pertaining to human medicines
Desired Work Experience:
- 2 to 5 years Pharmaceutical Manufacturing
- 2 to 5 years Pharmacist
Desired Qualification Level:
- Degree
About The Employer:
Leading Multi-National Pharmaceutical Company
Employer & Job Benefits:
- Car Allowance
- Vehicle Insurance
- Fuel Card
- 13th Cheque