Regulatory Affairs Pharmacist - Gauteng
mna
A global pharmaceutical company has a vacancy for a Regulatory Affairs Pharmacist to co-ordinate, project control and provide regulatory support for Central, East Africa and Mauritius countries. Key Responsibilities: Keeping abreast of regulatory requirements in Central, East Africa and Mauritius countries. Ensure the completion of submissions/ variations according to Central, East Africa and Mauritius strategic plan and timelines. Drive registration/variation follow up strategies and find solutions to potential supply challenges. Ensure that labelling for Central, East Africa and Mauritius is complaint with in-country specific requirements. Ensure master product tracker is up to date and accurate at all times. Ensure alignment to all other trackers that are linked to the master. Conduct Due diligence activities Co-ordinate and compile documentation for submission in Central, East Africa and Mauritius countries (New submissions/variations/RA documents) where required. Liaise and communicate with and support local agent in each country to meet regulatory requirements and timelines. Liaise and communicate with QA, Supply Chain and PV departments to ensure compliance and alignment with the various functions (including samples ordered for renewals, variations, and new submissions). Respond to product-specific queries from Central, East Africa and Mauritius countries where required. Co-ordinate internal back up and filing (electronic and hard copy) of dossiers and relevant communication. Download information from external portal i.e. Docubridge, sharepoint, we-transfer or regulatory drive. Arrange for translations of overseas documentation if required. Schedule Microsoft team meetings or teleconferences as needed. Conduct training sessions with Central, East Africa and Mauritius Team to ensure quality submissions in line with guidelines and upskilling of team members. Standardize folder structures and save information on NRD - Central, East Africa and Mauritius folder. Liaise with principals or the company with regards to outstanding information. Verify documents for completeness and current information. Compile and maintain spreadsheets and status reports as needed and upon request. Compilation of work map trackers to ensure visibility of tasks. Ensure Central, East Africa and Mauritius registrations are renewed in a timeous manner and retention fees are paid as required. Assist with task risk management and compilation of risk plans when associated with submissions. Ensure the completion of all assigned Company training within the specified timelines. Forward all received Product Quality Complaints, Adverse Events and Medical Enquiries to the relevant person in Quality Assurance/ Pharmacovigilance/ Medical Affairs Qualifying Requirements are: Must have a completed Bachelor of Pharmacy Degree and/or equivalent. 3-5 years’ experience in pharmaceutical industry (Regulatory Affairs/ Quality/ Production). Should have a sound knowledge of Sub-Saharan countries regulatory requirements and guidelines. Must have experience and understanding of electronic document management systems / eCTD. High level Computer literacy. People skills – highly adapted interpersonal skills. Problem solving analysis skills. Priority setting – initiative and follow through. Time management and ability to self-motivate. Strong attention to detail. Ability to work under pressure. Embodies Values & Behaviours in all internal and external interactions Candidates that meet the criteria may submit their applications via this portal or via vacancy link on www.mnarecruitment.com Should you receive no feedback within 7 days, please accept your application as unsuccessful.
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