BIOVAC is one of the leading sterile vaccine manufacturers rooted in Africa, with our core purpose being to "protect life". We are looking to hire a dynamic, passionate, confident, proactive and meticulous Africa Product Registration Manager to join a goal-oriented team.QUALIFICATIONS NEEDED: Degree in Pharm-B. Pharm/ Batchelor of Science/Health Science degree.Post graduate diploma/ Postgraduate (Honours or master's degree) will be preferred.Recognition is given to Prior Learning and practical experience.NECESSARY EXPERIENCE & INDUSTRY KNOWLEDGE:At least 5 - 8 years' experience in vaccine/ biotech industry or equivalent.At least 3 - 5 years' experience at middle management level.Experience in quality and regulatory compliance within a cGMP facility.Business and operational planning.Program and project management.Assist the HOD in developing departmental budgets and monitoring of expenditure for multiple projects and funding sources.Regulatory compliance knowledge, i.e. SAHPRA, ZAZIBONA (West or East Africa Community) and WHO.Experience in commercialization, auditing of and setting up of contracts with third parties.Experience in a Regulatory capacity, ideally in an African regulatory environment, which includes licensing of products in a manufacturing context.Established networks with relevant Regulatory authorities to allow for maximum efficient outcomes in interactions.KEY DUTIES & RESPONSIBILITIES OF THE ROLE: Shared accountability as Africa Product Registration Manager for achieving the site's tactical plans and mitigation of any risk to the site operation including workflow, ethics, quality, finances, regulatory compliance and other material company requirements.Identify and continuously present key opportunities and synergies that will improve and/or expand the operation within own and/or other departments.Lead or participate in departmental and/or site wide projects.Monitoring & reporting on key operations, critical numbers and key performance indicators that impacts the business's short-, medium- and long-term objectives.Participate with the site management team in proactively mitigating risks and find solutions where possible.Effective and comprehensive costing, budgeting and expense management, taking all overlapping site activities into consideration.Ensure section planning, execution and finalization of new implementations to deadline and within budget. Secure resources and coordinate efforts of team members, projects, departments and third-party contractors or consultants in order to deliver to plan.Develop regulatory strategies and implementation plans for the preparation and submission of new products applications and or life cycle management of existing products in different African Markets.Direct the preparation and submission of regulatory applications, reports, or correspondence to all applicable NRA's.Provide responses to regulatory agencies regarding product information, issues and or committee recommendations.Ensure that applicable NRA's regulatory compliance fees are paid timeously.Formulate or implement regulatory affairs policies and procedures to ensure that regulatory compliance is maintained or enhanced.Provide regulatory guidance to departments or development project teams regarding design, development, evaluation, or marketing of products.Communicate regulatory information to multiple stakeholders and ensure that information is interpreted correctly.Monitor emerging trends regarding industry regulations to determine potential impacts on organizational processes.Assist the HOD to represent the company before domestic or international regulatory agencies and African NGOs on major policy matters or decisions regarding company products.Maintain current knowledge of relevant regulations, including proposed and final rules.Coordinate activities such as RA departmental audits, regulatory agency inspections of third-party manufacturers in the African continent.Provide regulatory input into change control, deviations and technical agreements.Responsible for regulatory intelligence.Participate in inspections, investigations, risk management and quality review.Provide regulatory input into advertising.Participate in the CMC process for the department.Work closely with local regulatory consultant for different countries for dossier submissions.Ensure registration of products with different National Regulatory Authority and shipping agents.Ensures compliance products with the current regulations in across the regions.Deliver regulatory assessment/advice as part of overall business planning/strategies.Timely communication to the Company on changes in Regulations impacting registered products in different countries.Keeps abreast on latest regulatory requirements and developments within different countries.Responsible for compilation of required documents from source countries for submissions, license renewals and annual registrations.Collaborate with the RA pharmacists for the maintenance of product registration dossiers for authorities.Ensure that the content, organization and overall quality of all regulatory documents and samples are adequate and complies with local/regional regulatory requirements, commitments and agreements.Ensure that regulatory submissions to the relevant authorities for registrations and license renewal.Maintain database with information on regulatory requirements per country.Have regular contact with RA HOD to discuss regulatory issues and updates.
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