Registration Specialist

Sanofi Ukraine, one of the leading pharmaceutical companies, announces position of the

Registration Specialist (Regulatory Affairs).

KEY RESPONSIBILITIES:

• Preparation of application forms, registration forms, drafts of instruction for medical usage, statements, letters, variation dossiers;
• Ensuring optimal support to key stakeholders to provide on-time high quality documents in compliance with requirements;
• Coordination of procedures according to the plans;
• Actively participation in the file preparation;
• Preparation of administrative documents: mail, legalization, translation requests, archives;
• Functions of the assistant of the regulatory department in case of need.

REQUIREMENTS:

• University Degree in Biotechnology, Pharmaceutics, Medicine (or related field) - completed/incomplete;
• Experience & knowledge: regulatory issues; pharmaceutical industry; the quality control of pharmaceutical and biotechnological products (preferable);
• Experience in similar position in different types of registrations, preferably in multinational organization as additional skills are welcome (preferable);
• Knowledge of relevant legislation and regulatory guidelines, Good Practices, both national and international.
• English (both verbal and written) - intermediate level;
• Good negotiation and interpersonal skills;
• Attention to details, accuracy, analytical skills;
• Ability to organize, multitask, prioritize and work under pressure;
• Knowledge of MS Office (MS Word, MS Excel, MS Outlook, MS PowerPoint) - user level.

CORE COMPETENCIES /SKILLS:

• Strong interest for regulatory issues, integrity and strong feeling for ethics;
• Striving for excellence in standards and methods of work;
• Excellent communication, training and administrative skills;
• Demonstrate flexibility, resilience and tenacity in complex and changing environment.

COMPANY OFFERS:

• Opportunities for professional and career growth;
• Competitive remuneration;
• Medical insurance, lunches etc.;
• Work and development in highly professional team.