- ExperienceYears of Experience
- EE or Non EE PositionNon EE Position
- Driver's LicenseNot Required
- Disability PositionNo
- QualificationGrade 12 (Matric)
Regulatory Affairs Pharmacist (AA Position) – JHB – iS046584VL
Our client requires the services of a suitably qualified / experienced Regulatory Affairs Pharmacist.
Reporting Structure: Head of Regulatory Affairs Southern and South Africa
• Bachelor of Pharmacy Degree
• Registered with the South African Pharmacy Council (SAPC)
• 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
• 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 and Negotiation skills (fluency in English)
• Intermediate to advanced level computer 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’ and Analytical thinking
• Change agility/adaptability
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.