Вакансія Regulatory Manager (pharmacovigilance)

RB is the world's leading consumer health and hygiene company.

Every day, across 60 countries, we work with the best people to challenge conventional thinking and strive to find even better ways to give people innovative solutions for healthier lives and happier homes.

High impact, consumer-led research is the heart of the company's success. Ranked in the TOP 20 on the London Stock Exchange, our relentless drive to outperform has trebled our revenue since 2000 and quadrupled our market cap.

We announce vacant position Regulatory (pharmacovigilance) Manager

MAIN RESPONSIBILITIES:

Regulatory activities

• Planning and managing of medicine products registration process according to the company business plan;
• Planning and managing local regulatory submissions in compliance with local regulatory Requirements;
• Developing Normative documents, Patient Information Leaflets, and product packaging Artworks;
• Communication with Regulatory Authorities, outside organizations, and contractors regarding registration of medicine products
• Preparing responses to the Ukrainian Regulatory Authorities requests;
• Preparation of contracts/agreements associated with registration processes of medicine products/food supplements;
• Obtaining import permits (license) for reference standards and samples;
• Foreseeing changes in regulatory environments, alerting the management about upcoming changes & changing the product development, regulatory & manufacturing strategies accordingly;
• Ensure regulatory support to GMP inspections; assistance in preparing CAPA plan;
• Track product events, complaints and recalls;
• Interactions with cross-functional teams (Logistic Department, Marketing Department, Quality Department, etc.).

Pharmacovigilance activities

• Maintenance of the Global Pharmacovigilance system;
• Management of ADRs (collecting, reporting, obtaining follow up, detection of duplicates);
• Submission of PV documents (PSUR and other) to Competent Authorities;
• Local literature search, sending reports to the HQ of the performed local literature search;
• Preparation and update of local pharmacovigilance SOPs and ensuring implementation of SOPs concerning global PV System of company and local PV processes;
• Continuous pharmacovigilance education and training including training other company staff (medical representatives etc.);
• Act as a single contact point for the Competent Authorities;
• Communication and sharing information with the PV Unit of the HQ, including reporting any changes in the PV legislation.

REQUIREMENTS:

• Medicine or Pharmacological degree is a must;
• Relevant experience in Regulatory Affairs/Pharmacovigilance (minimum 2 years);
• Experience and knowledge in other relevant areas (such as research, quality control, manufacture or quality assurance) within the pharmaceutical industry and relevant aspects of the law will be a plus;
• Upper-Intermediate level of English is a must;
• Excellent organizing skills, good oral communication and writing skills, reading comprehension skills, attention to details

We propose:

• Official hiring + social package
• Getting X-functional and international experience
• Getting quick various experience related to real business environment
• Implementation of the initiatives