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Principal Regulatory Officer - Research Jobs - National Drug Authority (NDA)

Organisation: National Drug Authority (NDA)
Duty Station:  Kampala, Uganda
Reports to: Director Product Safety

About US:
The National Drug Authority (NDA) is an autonomous body which was established by the National Drug Policy and Authority Act Cap 206 , Laws of Uganda (2000 Edition) to regulate Human and Veterinary Medicines and other healthcare products. NDA’s mandate is to ensure quality, safety and efficacy of human and veterinary medicines and other healthcare products through the regulation and control of their production, importation, distribution and use.

Job Summary:  The Principal Regulatory Officer – Research will provide support in the regulatory oversight and coordination of operational research and studies within NDA

Key Duties and Responsibilities:
·         Plan and coordinate the initiation of research protocol, and support establishment of operating policies and procedures in line with NDA’s overall policy framework.
·         Maintain detailed knowledge of all assigned protocols and ensure that the regulatory officers adhere to all protocol requirements to ensure the validity of the research data.
·         Tasked with initiating, coordinating and carrying out appropriate research for the enhancement of regulation of medicines, public health products and medical devices
·         Responsible for ensuring that all research studies maintain accurate and up-to-date regulatory files.
·         Provide quality assurance of all essential documents maintained by the local personnel on site (e.g. source documents in participant files, laboratory documentation, Clinical Trials, Post Market Surveillance findings). This may be accomplished through periodic site visits for review of these documents
·         Ensure the smooth and efficient day-to-day operations of research and data collection and documentation of research activities within the Authority.
·         Responsible for overseeing the collection, reviews for adherence to regulation, and tracks all regulatory documentation involved in studies
·         Plan research programs in areas that are pertinent to NDA and to ensure that such programs are implemented
·         Actively participate in GMP/GPP inspections.
·         Disseminate research findings, presented in a meaningful format that is understandable by a non- specialist audience.
·         Develop the capacity of staff in research
·         Undertake any other responsibilities, tasks or activities as may be assigned from time to time.

Qualifications, Skills and Experience:
·         The ideal candidate for the National Drug Authority (NDA) Principal Regulatory Officer - Research job placement should preferably hold a Bachelor’s degree in Pharmacy or Pharmaceutical Science
·         At least eight (8) years working experience in regulation
·         Five years’ experience in research
·         Proficiency in computer applications especially MS office packages
·         Impeccable level of Integrity
·         Keen attention to detail.
·         Excellent communication and interpersonal skills

How to Apply:
All suitably qualified and interested candidates are encouraged to send a cover letter, copies of your academic qualifications together with your Curriculum Vitae (CV) indicating three (3) referees of whom one (1) should be your current or most recent employer either electronically to the e-mail address- or hand delivered to National Drug Authority office, 1st Floor, Rumee, Plot 19 Lumumba Avenue opposite TWED PLAZA. Your application should be addressed to the Head Human Resources and Administration, National Drug Authority.

Deadline: 10th January 2018

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