Regulatory Affairs Portfolio Lead Prescription - Midrand at Adcock Ingram

Job Purpose : 

• Timeous new product dossier submission, drive product registration, product life cycle management, compliance and meeting of deadlines set by the Regulatory Affairs Management.
• 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).

Key Job Outputs : 

• Managing the portfolio of products as
• Participate or coordinating all meetings related to the product portfolio and providing RA feedback to the
• Carry out special projects assigned by the RA Manager/Head of
• 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
• Ensure approval of registration applications of all medicines with the relevant
• Ensure the maintenance/update of registrations in accordance with the relevant legislation, regulations, and
• 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 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.

Core Competencies :

• Good verbal and written communication
• Strong detail, quality, and compliance
• Sound project management
• Attention to details and
• Good time
• Proactive, motivated and
• Ability to understand stakeholder needs.
• Output
• Support team cohesion.

Job Requirements

• Bachelor’s degree in pharmacy.
• 3 - 5 years’ experience in Regulatory Affairs, preferably in orthodox, human
• medicines. Biological/Biosimilar experience advantageous/preferred.
• Demonstrable experience across the product development, commercialisation, and life cycle 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.
• Experience and knowledge of SAHPRA electronic platforms and engagement portals.