Career Category

Job Description

Accountabilities:

Reports to Senior Manager Regulatory Affairs

• To ensure the correct preparation and presentation of all necessary documentation required to be submitted to the Regulatory Authority (RA) in order to obtain the authorization of all dossiers for registration and to enable future follow-up of the same.
• To ensure the correct preparation and presentation of all necessary documentation required to be submitted to the Regulatory Authority (RA) in order to obtain the authorization of all Clinical Trials and to enable future follow-up of the same.
• Dossier maintenance and compliance updates to latest requirements with the relevant Regulatory Authorities (RA).
• Such documentation will be fulfilled according to company policies, as well as those of the current local legislation, always guaranteeing its quality, the coherence of the information contained therein and an adequate coordination.
• Communication with Regulatory Authority i.e. follow-up on status of submissions.
• To perform Deputy Responsible Pharmacist duties, where applicable.

Responsibilities:

• Ensuring that local processes, strategies and initiatives are aligned with regulatory requirements.
• Provide regulatory expertise into International Regulatory Affairs group.
• New dossier compilation and submission for registration in line with RA requirements.
• Advocate and actively support regulatory compliance for products.
• Life Cycle Management of dossiers to local and international standards.
• Dossier compliance to accepted regulatory standards.
• Review and approval of relevant label translations in Afrikaans (additional, but preferred)
• CTA management (preparation, submission, Q&A) in order to process every clinical trial’s application, modification and communication, to the Regulatory Authority (RA) and Ethics Committee(s) (EC) until final response is received.
• Notifying the RA and EC of all relevant information, line listing, progress and status of Clinical Trials.
• Acting as liaison/contact person with Corporate for all Clinical Trials regulatory matters (CTAs receipt, reporting of incidences in documentation, communicating date of submission and trial authorization).
• Support Quality Assurance on relevant permits, exemptions and applications
• Follow Corporate Regulatory recommendations:
  • Participates in study-related meetings (network monthly TC, annual meeting, face to face meeting) organized by Corporate Regulatory Affairs
  • Follows up national regulations and forward changes or new requirements to corporate
  • Compilation of information relating local Clinical Trials Legislation and distribution to Global
  • To supervise and validate the labelling of the medication under study according to current legislation requirements.
  • Follow up with the relevant regulatory bodies on progress of applications
• Database maintenance (regulatory and clinical trials), both locally and regionally
• Review and approval of marketing/commercial and medical artwork and material in line with relevant Acts, Regulations and Guidelines.
• Ensuring labelling excellence in affiliate executed artwork.
• Special shipment approvals (SSAs) in SAP, if and when required.
• Contributing to budgeting compilation and maintenance.
• Representation of local RA affiliate to both local and above country cross-functional teams, travel may be required (Covid permitting).
• Ensuring continuity of RA projects and or submissions outside allocated responsibilities.
• Initiating, maintaining and training on RA SOPs.
• Compliance with local legislations in dossier and artwork maintenance.
• Ensuring ethical integrity and code of conduct when interacting with Regulatory Authority in line with local legislation and Company policy.

Authority:

• Regulatory engagements with local Regulator.
• Internal regulatory engagement in country and above country.
• Dossier registration and associated life cycle management.
• Promotional, Non-promotional and Value Access material review.

Outputs:

• Project management and liaising with International Regulatory Affairs, R&D, Safety, Operations, Labelling and Publishing to communicate South African specific requirements at all times.
• Review potential variations classification and guide Global in terms of SAHPRA requirements, and timelines for implementation.
• Review of proposed artwork and packaging material for appropriateness (including all subsequent drafts), against the Marketing Code, Regulations, the Act and Amgen SOPs, to provide guidance to sales and marketing team, regarding acceptability of potential advertising material and to ensure compliance with company policy.
• Regular follow-up and liaising with all SAHPRA committees to ensure responses are timeously obtained (for all products in the registration process).
• Follow-up on submitted variations, to ensure timeous approval.  Maintaining internal database with all tracking of SAHPRA timelines from dossier submission to registration.  Correspond with internal and external stakeholders regarding approvals, registrations, rejections, recommendations.
• Timeous update of all internal electronic database records with submissions, SAHPRA responses, Company responses and approval dates ensuring coloration with hardcopy dossiers.

Qualifications:

Minimum Requirements

• BPharm Degree.
• Advanced knowledge of local and international regulatory requirements including Regulations, Guidelines, Regulatory Processes and Operations. (3 years’ experience preferable)
• Thorough knowledge of local clinical trial regulatory and ethical requirements and applicable laws.
• Fluency in oral and written English.
• Computer skills must include working knowledge of Microsoft Office (Outlook, Word, Excel, and PowerPoint).
• Effective project management skills for multiple tasks/projects/priorities and complex issues to propose innovative solutions.

Preferred Requirements

• Industry Association awareness and involvement.
• Afrikaans as an additional language preferred but not pre-requisite.

Skills & Competencies:

• Ability to work with significant autonomy.
• Ability to understand and communicate scientific information.
• Appropriate experience in the Regulatory environment.
• Computer skills must include working knowledge of Microsoft Office (Outlook, Word, Excel, and PowerPoint).
• Good communication skills.
• Results Driven.
• Effective project management skills for multiple tasks/projects/priorities and complex issues to propose innovative solutions
• Ability to prioritize.
• Proactive in nature.
• Problem solving skills.
• Ability to monitor project closely, including time management and effective planning ability.
• Effective interpretation of SAHPRA Guidelines and documents pertaining to Dossier management (MRF/CTD/eSubmission/eCTD) – dossier review and submission updates.
• Afrikaans as an additional language preferred but not pre-requisite.

If required to act as the Deputy RP:

• As Deputy RP should understand:
  • The role of SAHPRA and other regional regulatory agencies in the licensing of medicines and as the competent authority including the risk-based inspection process, the role of the SAHPRA, SAPC and other regional regulatory agencies resulting actions that can be taken due to non-compliance.
  • The role of the Professional Bodies and Organizations that regulate those supplying medicinal products to the public.
  • The role of the NDoH and SAPC in relation to the handling of Controlled Drugs, the Principles and Guidelines of Good Manufacturing Practice (GCP) and how the principles of Good Distribution Practices (GDP) maintain product quality throughout the distribution chain.
  • The South African Regulations in relation to Wholesale Distribution.
  • The South African Code of Marketing Practice (MCA) for Health products.
  • Good Distribution Practice (GDP) - The prior relevant knowledge and experience related to the distribution of medicinal products.
  • Access to pharmaceutical knowledge and advice when it is required.
  • Knowledge of the products traded under the license.
  • Recognized Pharmacy qualification.

• As Deputy RP will be required to:

• Employ due diligence in the discharge of their duties, maintaining full compliance to procedures and appropriate regulations.
• Report to Senior Management, the Marketing Authorization holder and the SAHPRA or other Regional Regulatory Agencies any suspicious events of which they become aware.