Senior Regulatory Affairs Manager

Senior Regulatory Pharmacist

Reference : DBN -RC-1

A leading pharmaceutical company has a vacancy for a Senior Regulatory Pharmacist to join their team. The responsibility of this position is to coordinate, project control and provide regulatory support for ensuring continuous compliance and product supply.

Duties & Responsibilities

Key Responsibilities :

• Completion of all assigned training within the specified timelines.
• Forwarding of all received Product Quality Complaints, Adverse Events and Medical Inquiries to the relevant person in Quality Assurance / Pharmacovigilance / Medical Affairs.
• Ensure the availability of training plans according to the direct reports' role profiles within the team.
• Ensure that the relevant training has been completed according to the training plan.
• Keeping abreast of regulatory requirements in Central East Africa and Mauritius Regions countries.
• Ensure the completion of submissions / variations according to Central East Africa and Mauritius Regions' strategic plan and timelines.
• Manage the pharmacists / assistants with respect to the allocation and completion of high-quality submissions.
• Drive registration / variation follow-up strategies and find solutions to potential supply challenges.
• Conduct documented meetings with Business unit heads and supply chain to ensure alignment with RA strategies.
• Lead the Central East Africa and Mauritius Regions region in discussions relating to product launch / special projects / GRA interaction.
• Ensure that labeling for Central East Africa and Mauritius Regions is compliant with in-country-specific requirements.
• Drive clean-up exercises and compliance activities within registered product portfolios.
• Update Central East Africa and Mauritius Regions' statistics and promotional material statistics monthly.
• Ensure transparency of Central East Africa and Mauritius Regions activities and highlight department improvements.
• Ensure the master product tracker is up to date and accurate at all times. Ensure alignment to all other trackers that are linked to the master.
• Oversee the approval and conduct review of promotional material in SA and Central East Africa and Mauritius Regions.
• Ensure the promotional material review is populated, accurate, and that statistics are being accurately reflected.
• Oversee the approval and conduct review of artworks and mat packs in SA and Central East Africa and Mauritius Regions.
• Conduct Due diligence activities.
• Coordinate and compile documentation for submission in Central East Africa and Mauritius Regions countries (New submissions / variations) where required.
• Liaise, communicate with and support local agents in each country to meet regulatory requirements and timelines (including samples ordered for renewals, variations, and new submissions).
• Liaise and communicate with QA, Supply Chain and PV departments to ensure compliance and alignment with the various functions.
• Respond to product-specific queries from Central East Africa and Mauritius Regions countries where required.
• Coordinate internal backup and filing (electronic and hard copy) of dossiers and relevant communication.
• Download information from an 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 Regions 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 Regions folder.
• Peer review of documentation prepared by registration officer / pharmacist.
• Liaise with principals or Companies regarding 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 Regions registrations are renewed in a timely manner and retention fees are paid as required.
• Assist with task risk management and compilation of risk plans when associated with submissions.
• Conduct performance reviews and goal setting / objective setting for direct reports.
• Conduct audit preparation activities and mock internal audits.
• Be a leader in the Central East Africa and Mauritius Regions area and take responsibility for the overall execution of department objectives in line with company and global objectives.
• SOPs are developed and implemented for Central East Africa and Mauritius Regions' specific processes and in line with AQD's.

Requirements :

Candidates that meet the criteria may submit their applications via this portal or via the vacancy link on Should you receive no feedback within 7 days, please accept your application as unsuccessful.

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