Regulatory Affairs Manager

An international company has opened a competition for the position of Regulatory Affairs Manager 

Responsibilities:  

• Provide strategic planning and leadership to the Regulatory department by ensuring that appropriate structures, systems, competencies and values are developed; 
• Ensure that the interfaces between Regulatory and other departments are managed optimally; 
• Ensure effective team communication throughout the Regulatory department through the application of suitable reporting systems and structures and the identification and provision of appropriate training; 
• Plan, organize and implement strategies and activities required to procure Regulatory approval for new and modified product lines; 
• Influence through knowledge power to guide business managers at every stage during product planning to product launch;
• Responsible for the budget of the Regulatory function; Ensure costs are efficiently managed within budgets; 
• Engage in cross functional team activities from initial stages of product planning through till securing government approvals; 
• Educate team members appropriately to ensure accurate understanding of regulatory requirements and compliance to the same at every stage of development; 
• Ensure the Company complies with current Local Health Authority regulations in Russia and Division Guidelines for RA; 
• Maintain awareness of Russian Regulatory requirements; 
• Notify senior management of any notifications by Health Authorities or Regulatory Body for inspections, visits, permit renewals or licenses; 
• Proactively engage with regulators and health officials and maintain a positive relationship; 
• Educate management on any likely changes in the regulatory environment that may affect business.

Requirements: 

• 5 years + of deep expertise in medical devices / pharma/ FMCG/ Industrial / Food registration or sertification;
• English – Upper-intermediate/Fluent; 
• Poject management experiene; 
• People management experience; 
• Expertise in general business processes execution; 
• Experience in shaping environment initiatives; 
• Goal oriented, responsible, dedicated; 
• Excellent communication skills, good in listening, good problem-solving and influential skills.

Benefits:  

• Competitive salary; 
• Annual bonus; 
• Medical and life insurance; 
• Meal allowance; 
• Fitness compensation; 
• Mobile allowance; 
• Opportunities for professional development and growth.