Regulatory Affairs Pharmacist

• 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

• 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

MNA Recruitment