Regulatory Associate at IQVIA

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