Regulatory Affairs Pharmacist / Specialist (AA) –  (1 year contract)

South Africa

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.