Вакансии партнеров

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 AND PHARMACOVIGILANCE MANAGER, with an opportunity for fast growing and promotion.

REQUIREMENTS:
  1. Medicine or Pharmacological degree is a must;
  2. Experience in Regulatory Affairs (minimum 3 years);
  3. Experience in Pharmacovigilance (minimum 1 year);
  4. 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;
  5. Upper-Intermediate level of English is a must;
  6. Excellent organizing skills, good oral communication and writing skills, reading comprehension skills, attention to details, critical and analytical thinking;
  7. Collaborative, tactical, diplomatic.


MAIN RESPONSIBILITIES:

Regulatory activities

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

Pharmacovigilance activities

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


COMPANY OFFERS:
  1. Competitive salary;
  2. The official employment in accordance with the Labour Code of Ukraine;
  3. Career prospects;
  4. Professional development.


Contact Anastasiya Maximenko for details: +380 (97) 953-68-14, AMaximenko@upharma-c.com

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:
  1. Medicine or Pharmacological degree is a must;
  2. Experience in Regulatory Affairs (minimum 7+ years);
  3. Experience and knowledge in other relevant areas (such as research, quality control, manufacture or quality assurance) within the pharmaceutical industry will be a plus;
  4. Intermediate level of English;
  5. Excellent organizing skills, good oral communication and writing skills, reading comprehension skills, attention to details, critical and analytical thinking;
  6. Collaborative, tactical, diplomatic.

MAIN RESPONSIBILITIES:

  1. 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.
  2. Planning of regulatory procedures in co-operation with other departments;
  3. Planning and managing of medicine products/food supplements registration process according to the company business plan;
  4. Developing Normative documents, Patient Information Leaflets, and product packaging Artworks;
  5. Communication with Regulatory Authorities, outside organizations, and contractors regarding registration of medicine products and food supplements;
  6. Preparing responses to the Ukrainian Regulatory Authorities requests;
  7. Preparation of contracts/agreements associated with registration processes of medicine products/food supplements;
  8. Foreseeing changes in regulatory environments, alerting the management about upcoming changes & changing the product development, regulatory & manufacturing strategies accordingly;
  9. Interactions with cross-functional teams (Logistic Department, Marketing Department, Quality Department, etc.).

COMPANY OFFERS:
  1. Competitive salary;
  2. The official employment in accordance with the Labour Code of Ukraine;
  3. Career prospects;
  4. Professional development.


Contact Anastasiya Maximenko for details: +380 (97) 953-68-14

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UPharma Consulting, Ltd.

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Адрес
"АПфарма Консалтинг"
ул. Маршала Тимошенко, 21
корпус 7, офис 5
Киев, 04212
Украина

Телефон: + 380 (97) 953 68 14

E-mail: mailbox@upharma-c.com
Web: www.upharma-c.com