В международную фармкомпанию Boehringer Ingelheim приглашается Head of Regulatory Affairs & Government Relations (Animal Health).
Tasks
Establish overall regulatory strategy for Animal Health portfolio;
Collaborate closely with Global Regulatory, Industrial Operation teams, Global Quality and Commercial to ensure appropriate lifecycle planning;
Provide regulatory guidance to cross-functional groups regarding strategic aspects of manufacturing, quality, preclinical and clinical development and testing for Animal Health portfolio;
Manage a team;
Identify options and influence decisions;
Anticipate Health & Animal Health Authority initiatives and communicate areas of risk to project teams and line management;
Maintain awareness of new and developing legislation, policy and technical regulatory guidance relating to Animal Health portfolio;
Interact with company partners and consultants for various regulatory, quality and GR matters as needed;
Advocate company’s needs at Trade Associations level and Authorities’ meetings;
Interpret existing regulations and guidance documents for regulatory department and cross-functional teams;
Oversee development of submission content and documents - provide guidance when appropriate and other activities;
Be responsible for Pharmacovigilance.
Requirements
Diploma Degree (law, political science, international relations or economics preferred);
Work experience 3+ year in a similar / related position in a large foreign pharmaceutical company;
Strong leadership skills;
Fluency in English is mandatory;
Skills of regulatory & legislative analysis;
Business-oriented mindset;
Economic analysis and forecasting skills;
Analytical, communication, negotiation skills;
Critical thinking, problem-solving, and decision-making skills;
Willingness to implement innovative initiatives and creativity;
Team player, flexibility, stress tolerance;
Advanced PC user.
Offer
Competitive salary;
Social package: meal compensation, medical and life insurance, travel insurance;
Professional and friendly team;
Professional growth and development within stable global company.