Job Description

Job Summary Bachelor of Pharmacy degree
Minimum of 5 years proven experience in a pharmaceutical regulatory affairs environment including compilation and submission of variations, application for new products and life cycle maintenance in accordance with the latest regulatory authority requirements.
Registered with the South African Pharmacy Council as a practicing Pharmacist.
Experience in eCTD.
Expertise in Information and document management technology and electronic/paper publishing software.
Excellent written and verbal communication skills.
Thorough knowledge of world-wide Health Authority requirements on Regulatory technical format including processes and technologies.
Expertise in Information and document management technology and electronic/paper publishing software.
Excellent written and verbal communication skills.
Thorough knowledge of world-wide Health Authority requirements on Regulatory technical format including processes and technologies.
To ensure legal compliance with the relevant Health Regulatory Authorities, Medicines, and Related Substances Control Act 101 of 1965, as amended and South African Pharmacy Act (Act 53 of 1974), and other relevant regulations.
Knowledge of regulatory procedures and legislation for drug development, product registration, line extension and license maintenance.
Proven successful project management experience.
Proficiency in communication is essential for effectively presenting scientific and strategic concepts, whether through spoken or written mediums.
Demonstrated experience in elevating the capabilities of the organization for now and the future.
Broad background of experience of working in several groups in regulatory affairs or experience at a health authority.
Implement a registration plan and provide business support.
Provide regular feedback to the RA Manager and cross functional team and marketing teams on the regulatory submission progress of specific products and ensure support needed to drive performance in their respective departments.
Robust mitigation plans in place to engage.
Regulatory authorities when earliest signs of delay emerge. Proactively identify issues and manage risk, taking appropriate action as required on regulatory submission and identify and drive ongoing improvements.Quantity and Quality
Achievements of timely submission and approvals in line with the registration business plan.
Timeous, comprehensive, and accurate feedback to cross- functional teams.
Registration plan
Implemented and aligned with international priorities and local brand marketing strategy.
On-going proactive identification and action of opportunities and issues.Good Regulatory Practice (GRP)
Ensure that all the regulatory processes are performed timeously and in line with GRP.
Maintain GRP standards in the following process areas:
Marketing Authorization Applications
License maintenance e.g., Renewals
Pharmacovigilance e.g., LRMP
Labelling and Artwork Management
Robust Health Authority interactions
To track and manage all GRP activities and report any non-compliances to the Responsible Pharmacist.
Complete training in line with the training matrix relevant to job profile.
Marketing Authorization Applications: Submit Marketing Authorization Applications to the SA Health Authority according to SA HA guidelines and GRP, in the shortest possible time based on business priorities.
License maintenance: Ensure all post-approval product maintenance activities including CMC variations, package insert safety updates, new indications, technical changes to the label or the packs, PBRERs, and post approval commitments are submitted and approved. Ensure all dossiers are converted in line with legislative requirements.
Submissions compilation and dispatch: Complete due diligence of registration dossiers/ documents.
Obtain relevant information from global RA and resolve queries as they arise to ensure delivery of submissions within agreed timelines.
Labelling & Artwork Management: Ensure labelling and artworks are effectively managed through the company, Global Labelling Business Process.
Co-ordinate the operations of Gazelle through cross-functional departments.
Health Authority interactions: All communication with Health Authorities regarding submissions, product registration or maintenance throughout the lifecycle of the product is managed effectively.Quantity and Quality
100 % completion of training as stipulated in the training matrix.
Review of the Quality Manual and its processes for accuracy.
Review of registration status & market specific information for accuracy and completeness in the relevant global databases (ERV).
Number of submissions in line with registration plan.
Time to register new products vs. target and vs. industry norm.
Extent of compliance of submissions with SOP's and Health Authority guidelines.
Accuracy of content of documentation submitted.
Recording of risks in dossier at the time of submission.
No disruption of stock supply as a result of non-approval or non-submission of critical variations
Product labelling activities successfully completed within specified timelines.
Ensure adherence to company policies and procedures and compliance with regulatory submission requirements.Established stakeholder relationships and consolidated regulatory roleDevelop and maintain relationships with key internal and external customers.
Maintain visibility and accessibility, working in close collaboration with them to realise company objectives.
Build and maintain relationships with Health Authority to influence regulatory timelines and outcomes.
Communicate regularly with SA MC colleagues regarding regulatory requirements and objectives and share best practice ideas.
Ensure early interventions as per historical timelines.
Regular follow up with key SAHPRA personnel on the status of all outstanding approvals.
Regular follow up with Global RA teams on outstanding responses to MCC recommendations.
Positively represented the company to various stakeholders.
Attend local trade association meetings to network with other Pharmaceutical.
Companies for updates to regulatory requirements and best practices across SA including IPASA.Quantity & Quality
100% compliance with Ethical Interactions (EA) policies.
Critical milestone intervention plan achieved.
Internal tracking of timelines of all completed submissions.
Ensure responses to recommendations for new products and indications are responded to timeously and delays or earlier approvals are communicated to the business.
Positively represented to various stakeholders for constructive interactions with Health Authorities.
Regular contact with internal and external customers; feedback on quality of service and support & information provided.
Constructive feedback from regulatory and medical colleagues on sharing of best practices.Personal Effectiveness
Demonstrate rated skill levels and leadership effectiveness.
Maintain current knowledge of policies and procedures, standards of practice (SOP's) and Health Authority requirements.
Achieve competence in prescribed skills and knowledge.
Identify developmental needs and locate appropriate learning resources.Quality
Implementation of agreed developmental plan.Ultra PersonnelRecruiter

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