Sanofi Ukraine, one of the leading pharmaceutical companies, announces position of the Registration Specialist (Regulatory Affairs).
- 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.
- 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.