Опубликовано 4 недели назад
Regulatory Affairs Manager
On behalf of our client, a Swiss biopharmaceutical group, we are looking for a successful candidate to fill the position of the REGULATORY AFFAIRS MANAGER in Kyiv.
- Medicine or Pharmacological degree;
- Experience in Regulatory Affairs (minimum 5+ years);
- Experience and knowledge in other relevant areas (such as research, quality control, manufacture or quality assurance) within the pharmaceutical industry will be a plus;
- Intermediate level of English;
- Experience in Pharmacovigilance will be a plus.
- Excellent organizing skills, good oral communication and writing skills, reading comprehension skills, attention to details, critical and analytical thinking;
- Collaborative, tactical, diplomatic.
- Handle regulatory submissions (new registration, renewal, variations) - compile dossiers in accordance with company and local legislation requirements, perform all the necessary regulatory activities for the assigned products - order necessary documents for submissions, analyze dossiers, prepare methods of quality control, instructions for medical use, etc.
- Planning of regulatory procedures in co-operation with other departments;
- Planning and managing of medicine products/food supplements registration process according to the company business plan;
- Developing Normative documents, Patient Information Leaflets, and product packaging Artworks;
- Communication with Regulatory Authorities, outside organizations, and contractors regarding registration of medicine products and food supplements;
- Preparing responses to the Ukrainian Regulatory Authorities requests;
- Preparation of contracts/agreements associated with registration processes of medicine products/food supplements;
- Foreseeing changes in regulatory environments, alerting the management about upcoming changes & changing the product development, regulatory & manufacturing strategies accordingly;
- Interactions with cross-functional teams (Logistic Department, Marketing Department, Quality Department, etc.).
- Competitive salary;
- Life and health insurance;
- Corporate car provision;
- Career prospects;
- Professional development.
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