Job description
Qualification and Experience Required
Bachelor of Pharmacy or Bachelor of Veterinarian Medicine
Registered with the applicable board
Competencies:
Self-starter; Work under ambiguity; Team-player; Customer orientated; Ability to partner with stakeholders; Pro-active planning; Problem solving; Communication skills; Accountability; Self-motivated; Influence and Impact.
Position Overview:
To support the registration and maintenance of IQVIA products in East Africa.
To meet critical registration timelines in compliance with global and local regulatory standards.
Deliver innovative registration solutions in East Africa timeously in a cost effective manner.
Job Specifications:
Interact with Competent Regulatory Authorities, local technical representatives and consultants on product registrations and associated legislations.
Requires technical knowledge of East African regulatory agencies in order to support the EAGA project on availability of data and documentation driving registrations
Accountable for new registrations including and not limited to:-
Compile requirements for new territory
Submit ELRRTS requests to obtain the documentations needed
Write local submission documents (cover letter; application forms etc)
Translate dossier and labelling as required
Ensure payment of local fees
Work with LTR and consultants to submit dossier and follow up until approval with the Authorities
Coordinate with commercial organization in the territory for milestone dates towards registration and launch.
Ensure compliance to procedures and systems to maintain proper regulatory records.
Administers department databases and collaboration sites as required ensuring accuracy of information kept on the Regulatory Information System.
Support the EAGA Regulatory Affairs Manager as and when required in ensuring the content of promotional materials is in compliance with existing licenses/SPCs and local labelling.
Provide affiliate support to meet critical government registration timelines in East Africa.
Proactively search for regulatory solutions to accelerate the registration process and meet customer needs
Area: Based in Nairobi and must have the ability to travel locally and internationally
Language: Fluent in English and kwiSwahili