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Regulatory Affairs Processes Manager - Pharmaceutical in Gauteng - Emerging Search Consultants

Emerging Search Consultants

We are an International Recruitment Firm. We do niche recruitment and specialise in engineering, fmcg, oil & gas, sales & marketing, legal, financial, IT and HR recruitment Recruiter from sector Engineering, located in Gauteng, From 1 to 10 workers

    About this job ad 16 August

    Province

  • Midrand, City of Johannesburg, Gauteng
  • Description


  • To assist the RA Director to manage the Regulatory Processes related to all aspects of New Product Submissions, New Product Registrations and Life-Cycle management by ensuring high quality, timeous submissions and responses are submitted to all Health Authorities. To conduct and complete administration related to the Management of these processes for all products.
     
    Requirements, Qualifications & Experience:
     
    Education: BSc/ B Pharm or higher (post graduate) scientific degree
    Experience: 3-5 years�€� experience in a regulatory affairs covering all areas of the function.
     
    Duties & Responsibilities
     
    Provides regulatory intelligence to Company RA Managers/ Executives/ RA Director and CEO in delivering the Company Pipeline for submissions and registrations
    Assists the Regulatory Affairs Department Managers/ Executives and Director by providing:
    Regulatory intelligence pertaining to the current regulatory landscape and potential impact for the team and wider business related to Pipeline submission and registration for SA and SSA markets
    Up to date information on the different local and worldwide regulatory issues and specific regulatory requirements for different geographies that Company is involved in
    Ensures pre-registration stage gate product submission and registration activities on time in full by:
    Helps drive the pre-registration stage gate process at each level (IPD/ Pre- and Post- submission DDs/ MCC stage gates/ Pre-launch activities) by providing direction and guidance to ensure all milestones are achieved
    Ensuring that all assigned dossiers are submitted timeously to relevant health authorities and are followed up on regularly basis as per the MCC engagement plan and process in order to ensure first to market registrations
    Ensuring that the Regulatory Affairs Department follows the standards, protocols and processes around obtaining dossiers and gathering supporting data from suppliers following signing of supply / purchase / financial agreements
    Ensuring there are processes for complete RA quality checks on all documents submitted to the MCC and related authorities
    Ensures dossier Central Dossier and the Life cycle management teams registration activities are reported regularly:
    Attends and assists with the management of meetings within each team to ensure on time delivery of all objectives per team (bi-weekly meetings/ monthly OPCo/ Monthly Governance Deck/ RA Monthly reports/ MBR)
    Ensures on time reporting and minutes are available for the RA Director and CEO ahead of OpCO and Governance sessions
    Ensures any gaps in RA CDT and LCM processes are identified and closed through cross functional discussions and solutions.
    Supports and enables delivery for the Regulatory Affairs Department
    Supports the Regulatory Affairs Director and Regulatory Affairs Department Management team to ensure that company values and leadership standards are communicated and understood at all levels within the team
    Builds trust among team members by setting a highly visible example in terms of professional excellence and commitment to demonstrating Company values and competencies
    Participates and supports the establishment of a team culture that values, recognizes and generates high performance, supports innovation and challenges the status quo
    Participates in processes to share information and leverage initiatives across the department where appropriate
    Supports and encourages knowledge sharing between and or across Regulatory CDT and LCM (SA/ India/ SSA), QA, Portfolio, Medical, Project Management, Commercial, BD
    Constructs and maintains RA Monthly reports from RA Tracking documents using RA electronic systems
    Develops and manages stakeholder relationships
    Identifies and develops key relationships within the Company Regulatory CDT and LCM (SA/ India/ SSA), QA, Portfolio, Medical, Project Management, Commercial, BD
    Builds and pro-actively maintains critical relationships with the MCC and equivalent bodies in other countries to ensure streamlined submissions, evaluations and registrations
    Proactively manages relationships with the MCC�€�s units to ensure more effective streamlining of the company�€�s applications
    Assists various MCC�€�s committees in order to gain approval so that product registration with the Medicines Control Council can be pursued
    Engages and interacts with suppliers/ 3rd parties to explore synergies and opportunities for collaboration
    Cross Functional Integration support
    Ensures the team aligns with a matrix management approach
    Communicates company vision and service culture
    Provides input and feedback around how the function can service the business optimally  
    Engages, communicates and collaborates with various internal business units (e.g. Medical, Marketing and NBD)

  • Requirements

  • Language(s): English
  • Availability for travel: No
  • Availability for change of residence: No

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