Nina Lategan, RAC

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I am a B.Pharm educated Regulatory Affairs Professional with extensive experience in regulatory affairs, quality assurance, quality management systems, product lifecycle management and continuous improvement. I have worked as a licensed Pharmacist in both South Africa and the United Kingdom. As a Regulatory Affairs Professional, I place a high priority on establishing and maintaining Quality Management System (QMS) Principles, including leadership, evidence-based decision making, continuous improvement, customer focus, engagement of people and relationship management. I am a team-professional, highly focused to succeed and contribute to the organization I represent, the teams that I form part of, as well as my customers. I have a strong personal values system based on continued learning, personal growth, and professional development. Key Competencies:  CTD/eCTD compilation, variations, and renewals.  Conversion of existing submissions to CTD/eCTD format.  Marketing authorization applications in South Africa, Sub-Saharan Africa, East and West African countries, including Botswana, Ghana, Kenya, Mauritius, Madagascar, Namibia, Nigeria, Tanzania, Uganda, Zambia, Zimbabwe.  Product compliance activities (through the product lifecycle) for Regulated Markets.  Establishment license applications: Marketing Authorization Holders of Drug Products, Medical Devices and Medicinal Cannabis Products (incl. Cultivation, Harvesting and Manufacturing activities).  ISO 13485:2016 Medical Devices: Internal Auditor  Third-party audits and preparations for Regulatory Authority inspection readiness (GMP, GDP, ISO).  Quality Assurance and Quality Management System implementation and management.  Management of Product Complaints, Adverse Drug Reactions, Adverse Events & Pharmacovigilance activities.  Training of personnel on SOPs and related processes pertaining to activities of RA/QA/QMS. Key Achievements:  CEO Award, Cipla South Africa, July 2012 In recognition of excellence in Regulatory Affairs and Project Management.  Managed Cipla’s successful new product development and manufacture of Entiro™ Probiotic Capsules in collaboration with Bifodan A/S, Denmark and Professor Leon Dicks, researcher and developer from the Department of Microbiology at the Stellenbosch University.


United Kingdom Overseas Pharmacist Assessment Programme (OSPAP)
United Kingdom
2002 To 2003

North-West University - Formerly known as Potchefstroom University for CHE
Potchefstroom, South Africa
B.Pharm, 1999
1996 To 1999

Year Entered Profession

  • 2010-2014

Current Organization Type

  • Other

Job History

Regulatory Affairs Consultant (Contractor)
Calgary, AB, Canada
January 2020 - August 2020

Senior Regulatory Affairs Pharmacist
Cape Town, South Africa
September 2016 - June 2019

Regulatory Affairs Executive
Cape Town, South Africa
June 2013 - June 2016

Regulatory Affairs & Responsible Pharmacist
Cape Town, South Africa
December 2009 - May 2013

Cape Town, South Africa
May 2007 - November 2009

Relief Pharmacist
Sheffield, United Kingdom
July 2002 - April 2007

Highest Degree Earned

  • Baccalaureate/Bachelors/first university degree

Regional Interests

  • Africa
  • Europe
  • Global
  • North America