Regulatory Affairs Officer

SUMMARY:
A client of ours within the health sector is looking for a Regulatory Affairs Officer to join their stable team.

POSITION INFO:
Location:
Midrand

Requirements:

• Bachelor’s degree in pharmacy.
• 2 - 3 years’ experience in Regulatory Affairs, preferably in orthodox, human medicines.
• Compliance with the requirements of the Pharmacy Act (Act 53 of 1974) and the Medicines and Related Substances Act (Act No 101 of 1965 as amended)
• Demonstrable experience across the product development, commercialization, and lifecycle management
• Knowledge of new and emerging Acts, Regulations and Guidelines pertaining to the pharmaceutical industry
  Experience in use of CTD software builder and compilation of eCTD application will be an advantage

• Managing the portfolio of products as allocated
• Participate or coordinating all meetings related to the product portfolio and providing RA feedback to the stakeholders
• Carry out special projects assigned by the RA Manager/Head of RA
• Ensure timeous initiation and management of the registration process for new product submissions
• Completes specific pre-registration activities including receipt, screening, compilation, and timeous submission of dossier/s to the Regulatory Authority
• Ensure approval of registration applications of all medicines with the relevant authorities
• Ensure the maintenance/update of registrations in accordance with the relevant legislation, regulations, and guidelines
• Receives, prepares, and submits all applicable updates, variations, resolutions, and any other correspondence required by the Regulatory Authority (South Africa and SSA countries)
• Ensures that the Document Database is kept up to date by completing the required administrative activities for appropriate maintenance, co-ordination and accuracy of all dossiers and correspondence
• Completes dossier audits of Registered Products for the assigned products
• Conducts dossier due-diligences, post-registration variations for all applicable Regulatory Authorities in compliance with the latest regulatory guidelines and applicable Regulations within the specified timelines to support the business and strategic company objectives
• Establish and maintain effective relationships with Regulatory Authorities to ensure more effective streamlining of the company’s applications when required
• Building sustainable relationships with internal and external stakeholders to achieve regulatory goals
• Prepare, review, and adhere to Standard Operating Procedures (SOP’s) and local Regulatory Guidelines
• Keeping abreast of developments and changes in the local and international regulatory environments which directly impact Adcock products
• Effectively communicating these changes to relevant stakeholders to assess the impact on the business
• Supervise and develop other members of the team (RA Associates and RA Grad Students)
• Ensure alignment of personal and company value

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