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Опубликовано 1 день назад

Regulatory Affairs Manager

UPharma Consulting

verifiedпроверено

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branchКонсалтинг / Аудит

cityКиев

contactАнастасия Максименко

phone+38xxx-xxx-xx-xx показать

sitehttp://www.upharma-c.com

  • полная занятость
  • английский

On behalf of our client, a fast-growing pharmaceutical company in Europe, we are looking for a successful candidate to fill the position of the REGULATORY AFFAIRS MANAGER, with an opportunity for fast growing and promotion.

 

REQUIREMENTS:

  • Medicine or Pharmacological degree is a must;
  • 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.

 

MAIN RESPONSIBILITIES:

  • 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.).

COMPANY OFFERS:

  • Competitive salary;
  • The official employment in accordance with the Labour Code of Ukraine;
  • Career prospects;
  • Professional development.

 

 

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