Main Purpose of Job<\/p>\n
\tTo fulfil the position of regulatory affairs pharmacist within any division within the group.<\/p>\n
Key Performance Areas (Core, essential responsibilities \u2013outputs of the position)<\/p>\n
\tResponsible for new product applications.
\n\tCompilation and submission of Post \u2013Registration amendments to ensure dossier compliance.
\n\tResponsible for pre and post-registration SAHPRA Committee recommendation responses to ensure product registration.
\n\tResponsible for dossier updates, PI\/PIL updates to ensure compliance with current legislation
\n\tTo ensure approval and compliance of printed packaging material and promotional marketing material.
\n\tLiaising with the marketing department to facilitate the timely launch of products.
\n\tApproval of master batch documentation prior to product production.
\n\tResponsible for SOP implementation\/review, update and compliance.
\n\tManaging and maintaining the regulatory documentation filing system.
\n\tEnsuring regulatory compliance and quality-related records are available and retained.
\n\tEnsure ongoing regulatory compliance of the existing product portfolio.
\n\tEnsure awareness of legislative changes and trends that will impact the core function of the regulatory affairs department and hence the marketability of company products
\n\tLiaise with business development for regulatory requirements prior to dossier acquisition.
\n\tTraining and peer review of documents<\/p>\n
Minimum Requirements
\nEDUCATION<\/p>\n
\tBachelor of Pharmacy Degree<\/p>\n
EXPERIENCE<\/p>\n
\tMinimum 2 years\u2019 experience in regulatory affairs in any regulated regions e.g., South Africa Europe, UK, Australia, Canada, Japan<\/p>\n
SKILLS\/PHYSICAL COMPETENCIES<\/p>\n
\tDocubridge
\n\tSage
\n\tSmartsheet
\n\tSweet process
\n\tMicrosoft: Excel, Word, PowerPoint, Outlook<\/p>\n
BEHAVIOURAL QUALITIES<\/p>\n
\tTakes ownership.
\n\tIntegrity, bound to principles, confidentiality, and ethics.
\n\tStrong leadership skills.
\n\tGood communication skills.
\n\tGood organisational skills.
\n\tGood planning skills.
\n\tGood follow-up skills
\n\tAttention to detail
\n\tAssertive.
\n\tConscientious.
\n\tPatient.
\n\tCo-operative.
\n\tDeadline Driven<\/p>\n
DESIRABLE SKILLS & EXPERIENCE:<\/p>\n
\t2 Years\u2019 experience in regulatory affairs and attention to detail
\n\tCollaboration: Refers to formal and informal relationships.<\/p>\n
Responsibility towards:<\/p>\n
\tResponsible Pharmacist
\n\tProcurement
\n\tMarketing
\n\tNBD<\/p>\n
Apply via company website ( https:\/\/humanaccent.co.za\/who-we-are\/ ) or<\/p>\n
humanaccent.simplify.hr<\/p>\n
<\/p>\n","protected":false},"author":2,"featured_media":0,"template":"","meta":{"_promoted":"","_job_location":"","_application":"http:\/\/humanaccent.simplify.hr","_company_name":"Human Accent","_company_website":"https:\/\/humanaccent.co.za\/who-we-are\/","_company_tagline":"Human Accent is part of The Accent Group,\u00a0where our purpose is to create a world where everyone wins. We are guided by a set of unwavering values that drive our actions and enable us to make a positive impact on individuals, organisations, and communities alike. At... read more the heart of our endeavours lie our\u00a0core values\u2014Bravery, Curiosity, Connection, Building, and Compassion\u2014serving as the bedrock of our commitment to excellence and compassion in everything we do. Human Accent stands tall as a premier Talent Search and Management Consultancy.\u00a0We possess an unwavering focus on unlocking the true potential of the talent in your business. We are talent hunters guided by meticulous attention and innovative approaches. We specialise in the end to end management of the talent life cycle from talent acquisition, talent assessment and mapping, succession, development plans to talent analytics needed to measure real success.","_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":{"0":"post-36842","1":"job_listing","2":"type-job_listing","3":"status-publish","4":"hentry","5":"job_listing_region-gauteng","7":"job-type-full-time"},"jetpack_sharing_enabled":true,"_links":{"self":[{"href":"https:\/\/jobs.dataaxisnode.com\/southafrica\/wp-json\/wp\/v2\/job-listings\/36842","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=36842"}],"wp:term":[{"taxonomy":"job_listing_region","embeddable":true,"href":"https:\/\/jobs.dataaxisnode.com\/southafrica\/wp-json\/wp\/v2\/job_listing_region?post=36842"},{"taxonomy":"job_listing_type","embeddable":true,"href":"https:\/\/jobs.dataaxisnode.com\/southafrica\/wp-json\/wp\/v2\/job-types?post=36842"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}