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!
- 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.