We need someone who is working as a company pharmacist and is handling regulatory affairs as well as registration of products.
Key Duties and Responsibilities
- Develop regulatory strategies and link them with companies business plans
- Creating and implementing regulatory information management system which ensure follow up and timely registration of new and re-registration of existing products for Kenya and export markets.
- Dossier review, submission and augmentation, responding to queries and follow up
- Launching and negotiating import and export permits from regulatory authority
- Actively involved in regulatory affairs coordination for the EAC region
- Company link person with marketing authorities, pharmaceutical sector trade bodies in EAC region. Participating in these bodies to influence favourable legislation which improve the business outcome of the company
- Work in partnership with sales and marketing team to plan, strategize and execute marketing plans.
- Provide technical and regulatory support/input, where applicable on local and regional business agreement
- Ensure compliance and issued related to compliance are sorted in time
- Managing and coordinating production, QC , QA and GMP Inspections, .
- Responsible for Product release and is in compliance with GMP and Regulatory expectation
- Custodian of control substance in accordance to CAP 224
- Training coordinator for SOPs, CAPA, GMP AND QMS and any other training programmes which ensure understanding and compliance of current GXPs
- Recruit, train and retain different personnel
- Act as an information resource centre for product knowledge, train sale team on DAPA and SMART approach on pharmaceuticals sells
- Process and procedure improvement, work flow controls
- New product development
- A minimum of 3 years’ experience, should have worked in a pharma company.
- Holder of a Bachelor of Pharmacy or related fields
- Proficiency in Ms Word, Excel and PowerPoint
- Good written and verbal communication skills
- Ability to develop and maintain good relationships with staff and partners
How to Apply
Interested and qualified candidates should forward their applications including detailed CVS to Recruitment Manager on email firstname.lastname@example.org