Qualifications\/experience:<\/p>\n
\tPharmacy Bachelor\u2019s degree or equivalent in life sciences or technology-related discipline with minimum 2 years Regulatory Operations experience required.<\/p>\n
OR<\/p>\n
\tGrade 12 with at least 5 years pharmaceutical industry experience, with prior Regulatory Operations experience required.
\n\tExperience leading the management of projects\/timelines and collaborating with team members
\n\tExpertise in the use of a document management, eCTD format and regulatory submission requirements and eCTD publishing systems
\n\tAdvanced technical skills in best business practices for electronic regulatory document preparation and submission, and document and life cycle management systems
\n\tPrevious experience developing work instructions and generating SOP\u2019s that are consistent with health authority requirements and company business practices
\n\tProven ability to manage, streamline and collaborate to improve document preparation and management systems<\/p>\n
Key Job Outputs\u00a0<\/p>\n
\tResponsible for overseeing and guiding the operations of teams managing the creation, assembly, and publishing of electronic submissions, including New\u00a0 Product Applications and Life Cycle Amendments.
\n\tRepresents Regulatory Operations on project teams for matters relating to electronic submissions, driving timelines and deliverables related to submission\u00a0documents.
\n\tMaintain working knowledge of the regulations and processes that govern the content and maintenance of controlled documents required by the Health\u00a0 Authorities, ICH and internal working practices.
\n\tLiaise with functional source areas (clinical, quality, regulatory) to ensure documents are compliant with authoring style guide. Work with regulatory document\u00a0authors to achieve resolution and ensure that documents comply with regulatory and company guidance\/template specifications.
\n\tSupports and\/or leads the development, refinement, and implementation of internal processes, procedures, work instructions and training programs for\u00a0 submission production and operational support activities to the RA Systems Department. As needed, trains colleagues and project teams.
\n\tEnsure alignment of personal and company values.<\/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-21297","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\/21297","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=21297"}],"wp:term":[{"taxonomy":"job_listing_region","embeddable":true,"href":"https:\/\/jobs.dataaxisnode.com\/southafrica\/wp-json\/wp\/v2\/job_listing_region?post=21297"},{"taxonomy":"job_listing_type","embeddable":true,"href":"https:\/\/jobs.dataaxisnode.com\/southafrica\/wp-json\/wp\/v2\/job-types?post=21297"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}