Regulatory Affairs Assistant: Animal Health (Fixed Term Contract) at IQVIA

IQVIA is looking for a Regulatory Affairs Assistant for a leading Animal Health client based in Nairobi, Kenya. Successful candidate will be expected to travel. This role is a Fixed Term Contract. Candidates MUST be HIGHLY SKILLED IN ADMINISTRATORS who have a background working in a REGULATORY DEPARTMENT.

Job Description:

• Manage the Regulatory database by maintaining proper regulatory records for the East Africa territory.
• Assist with submission of promotional materials to the regulatory authorities.
• Assist the RA personnel with the compilation of registration packages to the regulatory authorities.
• Administrative – Co-ordinate the filing (hard copies and electronic copies) of RA documents in a timely manner, arranging payment and submission of RA documents.
• Handle administrative requests and queries from RA personnel.
• Fheir JD unless you want them in BLUE system.JD.ause we already have the LTRollow-up with the invoices from the Local Technical Representatives.

Qualifications and Experience:

Qualification

• Diploma in Business Administration
• Microsoft Office certifications

Experience

Business Administration experience (2 years)

Competencies:

• Attention to detail and problem solving skills
• Excellent written and verbal communication skills
• Strong organizational skills with the ability to multi-task
• Integrity and honesty
• Consistency regardless of workload and pressure

Key Objectives/ Deliverables:

Regulatory maintenance of existing product marketing authorizations (Assistance with product regulatory compliance by (e.g.: submissions of variations, renewals, notifications, commitments etc where required)

• Assisting with preparation of Regulatory submission package
• Assist with the completion of submissions and follow up until registration approval
• Keep updated on relevant regulations in the territory
• Assist RA personnel with any Global Product requests (e.g.: variation requirements and ad hoc requests)

Regulatory database (Ensure compliance to procedures and systems necessary to maintain proper regulatory records (e.g. hard copies and electronic copies on the affiliate database))

• Ensure the accuracy of the information (products, dates etc) kept in IQVIA ’s Reg. Database e.g. RAPID
• Coordinate appropriate electronic and/or physical archiving (within 14 days from approval notifications)

Promotional materials (Assisting in checking content of final submissions for the approved promotional materials in compliance with existing regulations)

• Check content of final submissions to the Regulatory Authorities (check cover letter, references and leaflets)
• Follow-up with Regulatory Authorities on promotional material submissions & approvals when required

New Registrations (non-EU) (Assist RA personnel to obtain new registrations in East Africa)

• Writing of local submission documents (cover letter, application forms…) when required
• Assisting with labelling translation (English /Kiswahili)

Requesting of local fee payments

If you meet the requirements, please submit your application on Linkedin and attach your latest CV. No emailed CV’s will be considered. If you have not received any feedback 2 weeks after the closing date, please consider your application as unsuccessful.