Job Purpose :\u00a0<\/p>\n
\tTimeous new product dossier submission, drive product registration, product life cycle management, compliance and meeting of deadlines set by the Regulatory Affairs Management.
\n\tCompliance 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).<\/p>\n
Key Job Outputs :\u00a0<\/p>\n
\tManaging the portfolio of products as
\n\tParticipate or coordinating all meetings related to the product portfolio and providing RA feedback to the
\n\tCarry out special projects assigned by the RA Manager\/Head of
\n\tEnsure timeous initiation and management of the registration process for new product submissions.
\n\tCompletes specific pre-registration activities including receipt, screening, compilation, and timeous submission of dossier\/s to the Regulatory
\n\tEnsure approval of registration applications of all medicines with the relevant
\n\tEnsure the maintenance\/update of registrations in accordance with the relevant legislation, regulations, and
\n\tReceives, prepares, and submits all applicable updates, variations, resolutions, and any other correspondence required by the Regulatory Authority (South Africa and SSA countries).
\n\tEnsures 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.
\n\tCompletes dossier audits of Registered Products for the assigned products.
\n\tConducts 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.
\n\tEstablish and maintain effective relationships with Regulatory Authorities to ensure more effective streamlining of the company\u2019s applications when required.
\n\tBuilding sustainable relationships with internal and external stakeholders to achieve regulatory goals.
\n\tPrepare, review, and adhere to Standard Operating Procedures (SOP\u2019s) and local Regulatory Guidelines.
\n\tKeeping 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.
\n\tSupervise and develop other members of the team (RA Associates and RA Grad Students).
\n\tEnsure alignment of personal and company value.<\/p>\n
Core Competencies :<\/p>\n
\tGood verbal and written communication
\n\tStrong detail, quality, and compliance
\n\tSound project management
\n\tAttention to details and
\n\tGood time
\n\tProactive, motivated and
\n\tAbility to understand stakeholder needs.
\n\tOutput
\n\tSupport team cohesion.<\/p>\n
Job Requirements<\/p>\n
\tBachelor\u2019s degree in pharmacy.
\n\t3 – 5 years\u2019 experience in Regulatory Affairs, preferably in orthodox, human
\n\tmedicines. Biological\/Biosimilar experience advantageous\/preferred.
\n\tDemonstrable experience across the product development, commercialisation, and life cycle management.
\n\tKnowledge of new and emerging Acts, Regulations and Guidelines pertaining to the pharmaceutical industry.
\n\tExperience in use of CTD software builder and compilation of eCTD application will be an advantage.
\n\tExperience and knowledge of SAHPRA electronic platforms and engagement portals.<\/p>\n
go to method of application \u00bb<\/p>\n
Apply via company website ( N \/ A ) or<\/p>\n
<\/p>\n","protected":false},"author":2,"featured_media":0,"template":"","meta":{"_promoted":"","_job_location":"","_application":"","_company_name":"Adcock Ingram","_company_website":"http:\/\/N%20\/%20A","_company_tagline":"Adcock Ingram is a leading South African pharmaceutical company with a proud 130 year heritage. It has a portfolio of trusted, quality brands and generics and an entrenched value system that assures integrity. Growing from humble beginnings as a small Krugersdorp pharmacy in 1890, Adcock\u2019s portfo... read morelio includes an extensive range of Prescription, Over-the-counter (OTC), Consumer and Hospital products and life saving hospital products.","_company_twitter":"","_company_video":"","_filled":0,"_featured":0,"_remote_position":0,"_job_salary":"","_job_salary_currency":"","_job_salary_unit":""},"job_listing_region":[11],"job-types":[12],"class_list":["post-21822","job_listing","type-job_listing","status-expired","hentry","job_listing_region-gauteng","job-type-full-time"],"jetpack_sharing_enabled":true,"_links":{"self":[{"href":"https:\/\/jobs.dataaxisnode.com\/southafrica\/wp-json\/wp\/v2\/job-listings\/21822","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/jobs.dataaxisnode.com\/southafrica\/wp-json\/wp\/v2\/job-listings"}],"about":[{"href":"https:\/\/jobs.dataaxisnode.com\/southafrica\/wp-json\/wp\/v2\/types\/job_listing"}],"author":[{"embeddable":true,"href":"https:\/\/jobs.dataaxisnode.com\/southafrica\/wp-json\/wp\/v2\/users\/2"}],"wp:attachment":[{"href":"https:\/\/jobs.dataaxisnode.com\/southafrica\/wp-json\/wp\/v2\/media?parent=21822"}],"wp:term":[{"taxonomy":"job_listing_region","embeddable":true,"href":"https:\/\/jobs.dataaxisnode.com\/southafrica\/wp-json\/wp\/v2\/job_listing_region?post=21822"},{"taxonomy":"job_listing_type","embeddable":true,"href":"https:\/\/jobs.dataaxisnode.com\/southafrica\/wp-json\/wp\/v2\/job-types?post=21822"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}