Regulatory Affairs Pharmacist/Specialist (Contract position)
South Africa - Sandton
ApplySummary: 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 (as applicable), 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 (as applicable), 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,databases and local regulatory drive to ensure a state of audit readiness.
Maintain compliance of local product artwork and promotional materials in line with local legislation, regulations and company standards
Review of dossiers and sign as pharmacist in the event that HRA, Southern Africa is not available for an extended period
Participate in internal audits as required.
Represent the regulatory team at product specific cross-functional team meetings.
Where required, represent company at the relevant industry trade association meetings.
Education:
Bachelor of Science degree or Bachelor of Pharmacy degree
Minimum of 4 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
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
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
Regulatory Affairs
