Reporting Structure: Head of Regulatory Affairs Southern and South Africa

We have an excellent opportunity available for an experienced Regulatory Affairs Pharmacist / Specialist to join our client, a multinational pharmaceutical company, on a 1-year fixed term basis.

We would welcome the opportunity to connect and provide further details if you feel this is the right role for you!

Minimum Requirements:

• Bachelor of Pharmacy Degree/Diploma
• Registered with the SAPC (South African Pharmacy Council)
• Minimum of 3 – 5 years’ experience in Regulatory Affairs in human medicines preferably biologicals (vaccines)
• Knowledge of regulatory requirements as pertaining to human medicines is mandatory
• Working experience in a manufacturing environment preferably vaccine/sterile is advantageous
• Management of change control and working with manufacturing sites to execute regulatory strategies
• 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 FDA, EMA, WHO and local country regulations would be advantageous.
• Knowledge of the Marketing Code of Practice
• Strategic thinker

Responsibilities will include:

• Support the local, regional and global regulatory organisation in the development, execution and implementation of country-specific regulatory strategies to support the submission and approval of Covid-19 vaccine in South Africa and Southern Africa. This includes new submissions and life cycle management.
• Develop strong cross-functional partnerships with in-country and above-country colleagues to effectively execute registration strategies for the product.
• Develop very strong partnerships with the contract manufacturing organisation, project lead, quality operations and GCMC colleagues.
• Responsible for developing, enhancing and managing relationships with regulatory health authorities (HAs) and Boards of Health (BoHs) including inspectorate and regulatory compliance and pharmaceutical evaluation.
• 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.
• Understand WHO process for Emergency Use Listing.
• Compile and submit new product applications and 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/or promotional materials in line with local legislation, regulations and company standards
• Represent the regulatory team at cross-functional team meetings and discussions with project team.
• Where required, represent company at the relevant industry trade association meetings.