Regulatory Affairs Specialist (Kazakhstan, Russia)

Responsibilities:

• Managing full cycle of medical devices registration - preparation, filing and registration dossier for the registration on the market in accordance with country’s legislation and standards - primarily Kazakhstan, but may be assigned to registration projects in Russia based on organizational needs and priorities
• Assesses regulatory intelligence to assist in the development of local, regional, and global regulatory strategies
• Determines requirements (local, national, international) and options for regulatory submission, approval pathways, and compliance activities
• Evaluates the regulatory environment and contributes to providing internal advice throughout the product lifecycle (e.g., concept, development, manufacturing, marketing) to ensure product compliance
• Anticipates regulatory obstacles and emerging issues throughout the product lifecycle and develops solutions
• Assists in the development of regulatory strategy and updates strategy based upon regulatory changes
• Provides regulatory information and guidance for product development and planning throughout the product lifecycle to the regulatory groups and others within the organization
• Compares regulatory outcomes with initial product concepts and recommends changes or refinements based on initial regulatory outcomes
• Negotiates with regulatory authorities throughout the product lifecycle
• Identifies the need for new regulatory procedures, SOPs, and participates in development and implementation
• Helps train stakeholders on current and new regulatory requirements to ensure organization-wide compliance
• Assists other departments in the development of SOPs to ensure regulatory compliance
• Provides regulatory input and technical guidance on global regulatory requirements to product development teams
• Advises stakeholders of regulatory requirements for quality, preclinical, and clinical data to meet applicable regulations
• Assesses the acceptability of quality, preclinical, and clinical document for submission filing to comply with applicable regulations
• Evaluates proposed preclinical, clinical, and manufacturing changes for regulatory filing solutions and proposes plans/strategizes (if appropriate) for changes that do not require submissions
• Identifies, monitors, and submits applicable reports or notifications to regulatory authorities during the clinical research process
• Provides regulatory information and guidance for proposed product claims/labeling
• Prepares and submits electronic and paper regulatory submissions according to applicable regulatory requirements and guidelines
• Monitors the progress of the regulatory authority review process through appropriate communications with the agency
• Communicates and interacts with regulatory authorities before and during the development and review of a regulatory submission through appropriate communication tools
• Works with cross-functional teams for interactions with regulatory authorities including panel meetings and advisory committees
• Attends local RA and QA Audits

Requirements:

• Degree in a relevant field
• Minimum of 2 years’ experience in Kazakh and Russian registration
• Experience in EEU registration is desirable
• Fluent in Russian with a good command of English
• Knowledge of the Kazakh language is desirable
• Experience in project management, writing, coordination, and execution of regulatory items
• Proficient user of MS Office, including Word, Excel, and PowerPoint
• Good communication skills, both written and verbal
• Ability to work independently with minimal supervision, consulting with superiors on unusual matters
• Results-oriented