Regulatory Affairs Manager Job in Kenya
Our client a well established global market leader in provision of Animal Health products and services is looking for a Regulatory Affairs Manager. He/she should be willing to travel.
- Obtaining new approvals and maintaining in-line products in Central & East Africa region.
- Develop regulatory strategies for the region by interacting/advising business colleagues.
- Assemble (according to global and regional regulatory affairs approved processes), submit according to timelines and manage regulatory submissions to support new product approvals and in-line products maintenance (renewals, variations, etc.).
- Foster and maintain professional relationships with the health authorities.
- Develop and update packaging material according to the local requirements of the region and Company’s policies.
- Update stakeholders, electronic systems and databases regarding regulatory requirements, submissions progress and approvals status on regular basis.
- Ensure regulatory/legal/corporate compliance of all company activities in the market.
- Fulfill pharmacovigilance reporting responsibilities.
- Must have a university degree in relevant discipline (i.e. chemistry, pharmacy, biology, veterinary medicine).
- Must have 6-10 years previous experience with regulatory affairs.
- Must have regional or international exposure.
- Must be Fluent in English.
- Excellent communication and interpersonal skills.
- Must be capable of managing negotiations with regulatory authorities.
- Strong organizational skills including the ability to prioritize workload.
- Strong sensitivity for multi-cultural/multi-national environments.
- Attention to details.