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.