Senior Regulatory Affairs Manager Gauteng

2 weeks ago

Pretoria, Gauteng, South Africa MNA Recruitment Full time
Senior Regulatory Pharmacist

Reference: DBN003526-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
  • 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, ensuring 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 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.
  • Compile 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.
  • SOP's are developed and implemented for Central East Africa and Mauritius Regions' specific processes and in line with AQD's.
Requirements
  • Must have a completed Bachelor of Pharmacy Degree and/or equivalent.
  • 5-8 years' experience in the pharmaceutical industry (Regulatory Affairs/ Quality/ Production).
  • Should have a sound knowledge of Sub-Saharan country's 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.
  • Embody Company Values & Behaviours in all internal and external interactions.

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

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