Regulatory Affairs Specialist

Job Purpose:

Regulatory Affairs Specialist is responsible for the day to day management of Regulatory Affairs activities for the Central Asia and Ukraine region.

What would be the responsibilities for this role?

• Ensure ongoing regulatory compliance with all applicable laws and regulations, and other regulatory bodies, in all Central Asia and Ukraine markets of sale.

• Lead day-to-day Regulatory Affairs operations by directly or indirectly managing internal individual contributors and/or managing third-party vendors to ensure timely project execution according to defined project strategies and timelines.

• Ensures timely delivery of regulatory approvals to support the Business Grid and Commercial Plan. Maintain product licenses as required. Oversee commitments and outstanding issues with regulatory authorities to maintain regulatory approvals and inspection readiness.

• Work with internal / external partners to ensure product samples are well received and transferred to local laboratories on time.

• Ensure product compliance, the content and quality of all regulatory documentation is adequate and sufficient to meet local and / or regional regulatory requirements.

What are the competencies required for this role?

Requirements:

• BS degree in Life Sciences is a plus (preferably in chemistry, chemical engineering, pharmacy)

• Postgraduate Qualification, M.Sc. is preferred

Experience:

• Previous experience in Regulatory Affairs is a plus. As well as understanding of principles, concepts, practices and standards of Regulatory Affairs job function

• Fluent in English, Kazakh and Russian is mandatory, and other local languages in Central Asia are a plus.

• Good understanding of principles, concepts, practices and standards of Regulatory Affairs job function