Job Title: Regulatory Affairs Pharmacist
Business Unit/Division: Regulatory Affairs
Job Type Classification: Permanent
Location – Town/City: Sandton
Location – Province: Gauteng
Location – Country: South Africa
Key Performance Outputs:
- 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.
- 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/BoH’s, 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.
Reporting Structure: Head of Regulatory Affairs Southern and South Africa
Minimum Requirements: 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:
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
Behavioural skills and
Attributes: Strategic thinker
Strong communication skills
Negotiation skills
Problem-solving abilities
Strong detail, quality and compliance orientation
Ability to understand stakeholder needs
Building strong peer relationships
Team player
Interpersonal acumen
‘Big-picture’ thinking
Analytical thinking
Change agility/adaptability
Desired Skills:
- Strategic thinker Strong communication skills Negotiation skills Problem-solving abilities
- Big Picture thinking
- attention to detail
Desired Work Experience:
- 2 to 5 years Pharmaceutical Manufacturing
- 2 to 5 years Pharmacist
About The Employer:
Leading Multi-Natinal Pharmaceutical Company
Employer & Job Benefits:
- Medical Aid
- Provident Fund
- Fuel
- Car Allowance
- Vehicle Insurance
- 13th Cheque
- Performance Bonus