Our client who is a global pharmaceutical leader is looking for a Regulatory Affairs Pharmacist/Specialist to join their winning team. Responsibilities: - Product portfolio management of registered products and products under review for registration in South Africa (SA) and relevant export territories. - Dossier maintenance - submission of variations in line with relevant regulatory requirements (country-specific and global requirements). - Regulatory control and compliance over labelling, packaging, advertising and promotion of medicines - Compile new product submissions specializing in NCE, CTD and electronic submissions - Compile clinical dossier meeting the requirements of the Regulatory Authority (RA) in SA and relevant export territories, within the given timelines, to gain product registration. - Complete due diligence checks and evaluation of prospective dossiers - Assist in the regulatory arrangements needed to place new products on the market. - Assist with regulatory... follow-up to facilitate faster registration submission and obtain faster approval - Liaise with and provide answers to queries on clinical matters connected to the products both with RA and with the International Principals - Manage updates and maintenance of all registration dossiers to maintain product licenses in SA and relevant export territories - Ensure variations and changes made to the registration dossier is properly controlled update the internal systems - Liaise and represent Takeda with the RA in SA and relevant export territories - Liaise with principal and international suppliers regarding registration /regulatory requirements and changing policies. - Other general Regulatory work e.g. comment of proposed guidelines / legislative changes - Exercise regulatory control over the labelling, advertising and promotion of medicines. - Ensure that variations and changes made to the registration dossier are properly controlled and maintained. Compliance: - Ensure compliance with the Approved Registration Dossier to meet specifications in each country (incl. export territories). - Ensure compliance with all the Acts controlling medicines in SA and relevant export territories Training - Perform internal training on product related issues, where required - Ensure Staff and /or Representatives are trained in terms of the Law and other applicable legislation applicable to the promotion and sale of medicines, where required Audit & Compliance - Ensure that business under control is meeting desired compliance levels. - Support the Quality Management system with the implementation of SOP’s BUSINESS SKILLS AND KNOWLEDGE - Excellent communication skills (verbal, written and presentation) - Problem solving - Sound judgment - Good negotiation skills - Proficient in MS Office - Ability to establish and foster excellent customer relationships - Planning and organizing skills CORE COMPETENCIES - Foster trust - Embraces Diversity - Execute plans - Propose solutions - Promote change - Be open and receptive - Continually develop LICENSES/CERTIFICATIONS: - Valid South African Driver’s license for motor vehicle. - Own vehicle that can be used for business Job Type: Temporary COVID-19 considerations: Always remember to sanitize when visiting any of our offices Application Question(s): - Do you have a valid SAPC registration - Do you have a valid drivers license with a reliable motor vehicle? Education: - Bachelors (preferred) Experience: - registration of medicines and submission of NCE.: 2 years (preferred) Application Deadline: 2022/08/17
Johannesburg South Africa

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