Regulatory Affairs Manager

компания "ancor" 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; be the face of the organization to regulators, participate in appropriate forums and convey the company’s point of view on all relevant matters; represents the company in industry associations. 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.