Job Title: Principal Regulatory Officer – Research
Organisation: National Drug
Authority (NDA)
Authority (NDA)
Duty Station: Kampala, Uganda
Reports to: Director Product
Safety
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.
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
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.
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.
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
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.
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
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.
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
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
Plan research
programs in areas that are pertinent to NDA and to ensure that such programs
are implemented
·
Actively
participate in GMP/GPP inspections.
Actively
participate in GMP/GPP inspections.
·
Disseminate
research findings, presented in a meaningful format that is understandable by
a non- specialist audience.
Disseminate
research findings, presented in a meaningful format that is understandable by
a non- specialist audience.
·
Develop
the capacity of staff in research
Develop
the capacity of staff in research
·
Undertake
any other responsibilities, tasks or activities as may be assigned from time to
time.
Undertake
any other responsibilities, tasks or activities as may be assigned from time to
time.
Qualifications, Skills and
Experience:
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
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
At least eight (8) years working experience in regulation
·
Five years’
experience in research
Five years’
experience in research
·
Proficiency
in computer applications especially MS office packages
Proficiency
in computer applications especially MS office packages
·
Impeccable
level of Integrity
Impeccable
level of Integrity
·
Keen
attention to detail.
Keen
attention to detail.
·
Excellent
communication and interpersonal skills
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- [email protected] 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.
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- [email protected] 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
January 2018
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