Profile

Nina Lategan, RAC

Contact Details

Canada
RegEx Pro

Social Links

Bio

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.

Education

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

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

Pharmacist
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