Rajappen is a Pharmacist, registered with the South African Pharmacy
Council, and has over two decades of extensive pharmaceutical
knowledge and experience in regulatory affairs, corporate affairs and
quality management practices. Kacy is a senior pharmaceutical
executive who is focussed, pragmatic, passionate and results driven.
Since 2007, Rajappen has been a Co-Founder and Director in KD
Consulting Pharmaceutical Solutions (KDC), a consultancy practice
supporting the needs of pharmaceutical, medical device, veterinary and
allied health companies in successfully delivering new products to markets and maintaining products inmarket. With her proven experience and track record within the industry, Rajappen has assisted companies
in developing filing strategies to facilitate registration of products in South Africa and Sub-Saharan Africa.
Rajappen’s intimate involvement within the pharmaceutical industry has allowed her to stay abreast of the
rapidly transitioning health care environment and strategically advise clients accordingly.
Since 2009, Rajappen is the Co-founder and Director of Umsebe Healthcare, a licensed South African
pharmaceutical company whose focus is on addressing the unmet medical needs of South African patients.
Rajappen is responsible and accountable for maintaining compliance of the Company’s product portfolio
and pipe line products, and ensuring quick access to market. Leading the company’s mid-long term plans
and strategy is top priority. Rajappen is also responsible for recruitment and developing the team to enable
high performance across all functions. With a vested interest in flattening the curve with the recent COVID19 pandemic, the company has collaborated with Thinking Crystal (Pty) Ltd, for the supply and distribution
of critical products required to manage the COVID-19 crisis.
Rajappen previously held the positions of Regulatory Affairs Departmental Manager and Medical Marketing
Manager at 3M Pharmaceuticals SA (Pty) Ltd (later known as iNova Pharmaceuticals). Rajappen was
responsible for ensuring the smooth, ethical functioning of the company by providing support for the
Marketing Department on Regulatory / Medical Strategic development, providing medical support to meet
business objective, participated in cross functional activities within the Division and responsible for
communicating and modelling management goals and values to assigned personnel. Rajappen also held the
position of Regulatory Affairs Pharmacist at Cipla-Medpro.
Some of the services that Rajappen is involved with across South Africa and Sub-Saharan Africa includes
amongst others: Regulatory consulting including Regulatory strategy development, Regulatory portfolio
management, Regulatory-Quality business management, Product registration and Registerability
assessments.
Rajappen is registered with the South African Pharmacy Council, Pharmaceutical Society of South Africa and
the South African Pharmaceutical Regulatory Affairs Association and is a member of the Regulatory
Committee of the South African Medical Device Association (SAMED) and well as IPASA (Innovative
Pharmaceutical Association South Africa). KDC is registered with and is a member of the Heath Products
Association (HPA).

Head of Regulatory Affairs –  MENA in Hikma Pharmaceuticals (Amman – Jordan):

BSc in Pharmacy from Jordan University, 1991

MSc in drug analysis from Monastir University, Tunisia, 1998

PhD in Pharmaceutical sciences from University of Lille II, France, 2005. PhD thesis was awarded with distinction and it was nominated for “State Prize” at the Pharmaceutical Academy in Paris.

I have been working in the pharmaceutical industry for around 30 years. Joined Hikma Pharmaceuticals in 1991 and worked in different technical departments, with many years of hands-on experience in the formulation and process development, as well as analytical development of oral and injectable generic products. I held the position of Technical Director in Medicef (a newly established sister company for Hikma in Tunisia) for seven years, where I established all the technical departments: QA, QC, Product Pipeline, technical transfer and Regulatory Affairs. I also headed the Research and Development – Injectables department in Amman for around 10 years and successfully developed and registered new generic products targeting global markets in USA, EU and MENA.

Currently, I am heading the Regulatory Affairs activities in the MENA region, contributing to the development of the Regulatory strategy as well as setting the required implementation plans and programs that ensure effective and efficient function’s performance to best serve business needs across the region; while overseeing the Regulatory Affairs operations considering compliance with the internal and external policies and legislations, including submissions of new products in the pipeline and the maintenance of the existing portfolio in more than 16 countries in the MENA region, with local regulatory affairs teams in the majority of these countries. Work closely with health authorities and work on shaping the regulatory environment through liaising with the local agencies, local pharmaceutical organizations and associations and other stakeholders.

 

Other Activities in the Educational Field:

Jordan University of Science and Technology-Deanship of Scientific Research:

• Member in the “Scientific Research Committee” during the scholar year 2019-2020.

Yarmouk University:

• Member in the Faculty of Pharmacy board during the scholar year 2018 – 2019.

Jordan University of Science and Technology (JUST) & Yarmouk University:

• Deliver lectures to 5^th year Pharmacy students on the application of certain concepts and technologies in the pharmaceutical industry, focusing on bridging the gap between theorical knowledge and practical application (started in 2017 till now).

Jordanian Association for Pharmacists:

Received an appreciation and recognition award from the “Jordanian Association for Pharmacists” for the significant contribution to the development of pharmaceutical industry in Jordan (March 2019).