Regulatory Affairs Manager

Regulatory Affairs Manager 

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.

Key Responsibility:

• 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.

Key Qualifications:

• 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.

Key competencies:

• 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.

Monthly gross salary: Ksh.250,000 - 300,000/= (Approx. 2,900 - 3,500 USD)depending on experience

Deadline: 1st March 2014   

Applications:

Send your up to date CV to:  professionals@summitrecruitment-kenya.com

Summit Recruitment & Training, Blixen Court, Karen road, Karen.

Only short listed candidates will be contacted. Please indicate in your email which position you are interested in.

Please do not apply if you do not meet the requirements of the job.