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.
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